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The landscape of data privacy is certainly dynamic and, at times, imposing. In particular, transferring data across borders can be difficult to navigate. Does your journey to responsible and compliant data governance seem daunting? Let’s explore some of the data privacy implications and their impact on research.

What is Brexit’s Impact on Organizations with GDPR Exposure?

In addition to the need for a lawful basis for processing personal data subject to the General Data Protection Regulation (GDPR) [1], directly regulated and contractually obligated entities must also have a basis to transfer personal data outside the European Economic Area (EEA). Valid transfer mechanisms include:

A blanket decision made by the European Commission (EC) that the destination jurisdiction maintains an adequate level of data protection [2]
Conformance with appropriate safeguards such as standard contractual clauses (SCCs) [3] or binding corporate rules [4]
Utilization of derogations such as informed consent from the data subject [5]

As the name implies, however, derogations should be limited exceptions rather than standard practice.

While the UK exited the EU on January 31, 2020, a grace period for the existing regulatory framework governing data privacy extended through December 31, 2020. [6] The flow of personal data from the UK to the EEA (and to those countries that were the subject of an adequacy decision by the EC at the time of Brexit [7]) was never in jeopardy. [8] However, a measure of uncertainty existed over the future state of EEA-to-UK transfers. The status quo of limbo persisted for another six months. [9] Then, on June 28, 2021, the EC adopted an adequacy decision ensuring the lawful transfer of personal data from the EEA to the UK. [10]

How does this Impact Data Transfer to the United States?

Litigation known as Schrems II [11] (July 16, 2020) resulted in the invalidation of the EU-U.S. Privacy Shield, [12] which served as an adequacy determination. The Court of Justice of the European Union (CJEU) judgement, though rendered after Brexit, remains authoritative in the UK, as well as in the EEA. Consequently, the Privacy Shield can no longer be used as a tool for data transfers from either the UK or the EEA to the US, and entities that self-certifying under the framework must decide whether to renew or abandon their related obligations (with associated costs), at least until a new paradigm for adequacy is established.

Furthermore, Schrems II has implications for relying on the appropriate safeguards for data transfer, including SCCs. Additional due diligence is required beyond contractual terms execution to demonstrate accountability. Essentially, the private entities involved in the transaction are responsible for ensuring an adequate—or GDPR equivalent—level of data protection throughout the voyage. These contractual terms cannot be susceptible to subversion along the way, given the actual circumstances in any particular destination.

What are Supplementary Measures?

The European Data Protection Board (EDPB) published recommendations on adopting and implementing supplementary measures necessary to legitimize transfers, including pursuant to SCCs. [13] The recommended steps are as follows:

Map data flows
Identify basis for transfer
Assess effectiveness of transfer tool(s)
Adopt supplementary measures, as necessary
Consider process for implementing supplementary measures and documentation, as necessary
Re-evaluate periodically

Foremost, organizations should map expected data flow, considering any onward transfers after the initial one outside the EEA. Then, organizations must assess local law and practice, conduct a risk/impact assessment, and implement any additional safeguards (contractual, technical, or organizational measures) for each implicated jurisdiction, given the particularized circumstances of the transfer. [14] This process based on relevant, objective, reliable, verifiable, and accessible information should be documented, with a rationale as to how the measures adequately safeguard the transfer. It is not necessary to repeat the assessment when transferring a specific data type to the same jurisdiction. This documentation must be available to supervisory authorities upon request.

It may be possible to avoid implementing supplementary measures if the implicated organizations, based on individual and broader experience in the relevant sector, conclude there is no reason to believe that any identified problematic legislation, [15] regulation, or practice will compromise the subjects’ fundamental privacy rights in the data transferred. More specifically, for example, parties involved in the transfer should conclude public authorities do not have disproportionate access to data, without notice, and private entities are adequately regulated so as not to inhibit adherence to the requirements of the SCCs. However, such a determination and the rationale need to be thoroughly documented and vetted.

Finally, organizations conducting international transfers of personal data have a continuing obligation to monitor changes in local circumstance and should have established processes to act accordingly.

To assist, the EC issued new SCCs in June 2021. [16] While the former SCCs may continue to support new data transfers until September 2021, all transfers must be based on the revised SCCs by December 2022. Importantly, the SCCs consider the fallout from Schrems II. To this end, per Clause 14:

The Parties warrant that they have no reason to believe that the laws and practices in the third country of destination applicable to the processing of personal data by the data importer […] prevent the data importer from fulfilling its obligations under these Clauses.

Moreover, to fulfill this warranty, any internal documentation supporting conclusions (e.g., practical experience with prior instances of requests for disclosure from public authorities, or the absence of such requests, covering a sufficiently representative timeframe) must be derived from a process of continuous evaluation and certified at senior management level. This documentation too must be made available to a supervisory authority upon request. As distinct from modifications to the SCCs themselves, adopting supplementary measures does not trigger an authorization by a competent supervisory authority. Consequently, these measures can be incorporated in the contract as long as they do not directly or indirectly contradict the SCCs.

Returning to the impact of Brexit, the new SCCs have no force and effect in the UK. [17] The Information Commissioner’s Office (ICO) advised UK controllers to continue to use the former EU SCCs. Organizations may make changes to the former EU SCCs so they are relevant to the UK, while not disturbing the substantive legal meaning of the clauses. Much the way Switzerland maintains its own SCCs, the UK intends to publish its own SCCs for transfers from the UK. The ICO warned after the Schrems II decision, organizations should conduct the same sort of assessment and adoption of additional safeguards to ensure sufficient data subject protection.

Illustratively, from a GDPR perspective, if clinical trial data is transferred from France to the US and, finally, to a commercial entity in Canada, the onward transfer from the US to Canada could be made pursuant to the applicable EC adequacy determination. The transfer to the US could rely upon SCCs, provided parties have performed the requisite due diligence and perfected all relevant documentation. Effective supplementary measures could include pseudonymization, where:

The US-based entity is contractually prohibited from re-identifying or receiving codes enabling re-identification of the subjects to whom the data pertains, and
an assessment concludes third parties would not be able to identify the subjects with other available information. [18]

It is important to also consider individual US states, not only federal laws. Colorado, as of July 2021, joins California and Virginia in having GDPR-like laws on the books.

Ultimately, organizations do not want to compromise their obligations or their data, and it certainly is no longer enough to adopt a reactive position. Instead, organizations can proactively establish an infrastructure and culture to support good data stewardship. Purposeful and strategic execution, such as implementing supplementary measures where appropriate, will help meet the complex regulatory landscape’s demands and mitigate today’s inherent risk involved in international personal data transfer.

References:

[1] Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

[2] Id. at Art. 45.

[3] Id. at Art. 46.

[4] Id. at Art. 47.

[5] Id. at Art. 49. See also European Data Protection Board, Guidelines 2/2018 on derogations of Article 49 under Regulation 2016/679 (May 25, 2018), https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_guidelines_2_2018_derogations_en.pdf.

[6] European Commission, The EU-UK Withdrawal Agreement, https://ec.europa.eu/info/relations-united-kingdom/eu-uk-withdrawal-agreement_en.

[7] See European Commission, Adequacy decisions, https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/adequacy-decisions_en.

[8] Information Commissioner’s Office, International transfers after the UK exit from the EU Implementation Period, https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/international-transfers-after-uk-exit/.

[9] European Commission, The EU-UK Trade and Cooperation Agreement, https://ec.europa.eu/info/relations-united-kingdom/eu-uk-trade-and-cooperation-agreement_en.

[10] Commission implementing decision of 28 June 2021 pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council on the adequate protection of personal data by the United Kingdom, https://ec.europa.eu/info/sites/default/files/decision_on_the_adequate_protection_of_personal_data_by_the_united_kingdom_-_general_data_protection_regulation_en.pdf.

[11] C-311/18, Data Protection Commissioner v. Facebook Ireland LTD, Maximillian Schrems, ECLI:EU:C:2020:559 (July 16, 2020) (holding Section 702 of the U.S. FISA does not respect the minimum safeguards resulting from the principle of proportionality under EU law and cannot be regarded as limited to what is strictly necessary, and the level of protection of the programs authorized by Section 702 is not essentially equivalent to the safeguards required under EU law.)

[12] Privacy Shield Framework, Privacy Shield Overview, https://www.privacyshield.gov/Program-Overview.

[13] European Data Protection Board, Recommendations 01/2020 on measures that supplement transfer tools to ensure compliance with the EU level of protection of personal data (June 18, 2021), https://edpb.europa.eu/system/files/2021-06/edpb_recommendations_202001vo.2.0_supplementarymeasurestransferstools_en.pdf (superseding draft recommendations available at https://edpb.europa.eu/sites/default/files/consultation/edpb_recommendations_202001_supplementarymeasurestransferstools_en.pdf) [Hereinafter Supplementary Measures].

[14] European Data Protection Board, Frequently Asked Questions on the judgment of the Court of Justice of the European Union in Case C-311/18 – Data Protection Commissioner v Facebook Ireland Ltd and Maximillian Schrems (July 23, 2020), https://edpb.europa.eu/sites/default/files/files/file1/20200724_edpb_faqoncjeuc31118_en.pdf.

[15] “‘Problematic legislation’ is understood as legislation that 1) imposes on the recipient of personal data from the European Union obligations and/or affect the data transferred in a manner that may impinge on the transfer tools’ contractual guarantee of an essentially equivalent level of protection and 2) does not respect the essence of the fundamental rights and freedoms recognised by the EU Charter of Fundamental Rights or exceeds what is necessary and proportionate in a democratic society to safeguard one of the important objectives as also recognised in Union or EU Member States’ law, such as those listed in Article 23 (1) GDPR.” Supplementary Measures, supra n. 13 at 22 n. 63, https://edpb.europa.eu/system/files/2021-06/edpb_recommendations_202001vo.2.0_supplementarymeasurestransferstools_en.pdf.

[16] Commission Implementing Decision (EU) 2021/914 of 4 June 2021 on standard contractual clauses for the transfer of personal data to third countries pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council, https://eur-lex.europa.eu/eli/dec_impl/2021/914/oj?uri=CELEX:32021D0914&locale=en.

[17] Information Commissioner’s Office, Standard Contractual Clauses (SCCs) after the transition period ends, https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/international-transfers-after-uk-exit/sccs-after-transition-period/.

As a drug makes its way through the development lifecycle, one of the most important relationships for a sponsor to maintain is with the Food and Drug Administration (FDA).

The FDA is responsible for protecting public safety and public health. Collaborating with sponsors to review and approve new chemical entities, the FDA’s main goals are to ensure the therapy’s safety and efficacy by reviewing the submitted data and providing scientific feedback to help usher the drug forward through approval, including negotiating a final label.

Interacting with the FDA

During the course of drug development, the FDA will grant at least three statutory meetings, including: a pre-investigational new drug (IND) meeting, a meeting at the end of Phase II, and a pre-new drug application (NDA) meeting. While these are three distinct meetings, sponsors may interact with the FDA otherwise on an ad-hoc basis if there is a need.

At each meeting, sponsors have the opportunity to present their program to the FDA, discuss certain issues they may have in mind, and reach an agreement on the proposed clinical plan and regulatory strategy moving forward. The FDA typically allots one hour per meeting, and there are many moving parts. It’s up to the sponsor to pay attention, hear exactly what is said, and to walk away with a sense of clarity. Transparency, scientific integrity, and credibility are of the utmost importance. Both the sponsor and the FDA should understand how the sponsor plans to proceed with the given advice.

Preparing to Meet the FDA

While sponsors will communicate with the FDA throughout a protocol’s lifecycle, being prepared for each meeting will yield great results. Completing a gap analysis beforehand helps sponsors see the bigger picture of the trial at hand – what early protocols will look like in Phase I, as well as the program all the way to approval. For rare disease trials, it’s especially critical to view the trial at large.

Since time with the FDA is finite, nothing is more important than clarity, transparency, and scientific credibility. Especially during the first meeting, sponsors are trying to build credibility with the FDA so the partnership turns into a collaboration. The smoother these meetings go, the better the collaboration between the sponsor and FDA.

Pre-IND Meeting

When preparing for a pre-IND meeting, sponsors must first submit a letter to the FDA requesting the meeting. The letter should contain itemized questions for the FDA to review and discuss. From there, the FDA will normally set up a meeting 60 days after the initial request. When the meeting is 30 days out, the sponsor needs to submit a briefing document, reiterating the questions and giving scientific detail for each issue discussed. The FDA will meet beforehand to reach an internal agreement before meeting with the sponsor, and to provide the sponsor with the remaining outstanding issues needing further discussion or clarification. This meeting beforehand becomes the basis for an in-person discussion with the sponsor. At the meeting itself, sponsors can focus on the components the FDA might not have addressed completely or at all.

A key aspect of a pre-IND meeting is manufacturing – and if done incorrectly, sponsors risk encountering a refusal to file or delayed approval. An efficient, regulatory strategy needs to include a clinical component and a chemistry, manufacturing, and controls (CMC) component, and both need to be carefully addressed with the FDA for a successful journey to approval.

End of Phase II Meeting

At the end of a Phase II study, sponsors will once again meet formally with the FDA. The purpose of this meeting is to discuss the end of Phase II results, as well as the final design of Phase III. Discussing and agreeing upon the dosage amount is important before initiating a large Phase III program. Sponsors must include what Phase III will look like, and identify any potential adverse events (AE) there may be, efficacy, studies, etc.

During a study, sponsors may generate unexpected data usually stemming from a safety issue. If that is the case, sponsors need to pause the study and communicate with the FDA. It’s not uncommon for the FDA to want to learn more, resulting in possibly putting a study on clinical hold.

Pre-NDA Meeting

The final formal meeting sponsors will have with the FDA is the pre-NDA meeting. Typically scheduled four to six months ahead of a formal submission, this meeting is considered to be an opportunity for the sponsor to talk about the following at a high level:

Program results
Location of results within the NDA
Addressing any issues raised in the development program
Follow up on any issues raised during the end of Phase II meeting

This meeting allows the FDA to resource plan with regard to review the program and to understand when the application is coming in itself. This is also a time for sponsors to ask questions about data analysis, integrated summaries for efficacy, or anything else relating to the application formatting. Similar to the pre-IND meeting and end of Phase II meeting, sponsors will have to submit material prior to the meeting for the FDA to prepare and review.

Who Goes to FDA Meetings?

Regardless of an organization’s size, key functional development staff for the protocol will attend, including:

Regulatory strategist
Clinical expert
Statistician
Clinical Pharmacologist
CMC expert
Pre-clinical toxicology expert

If a sponsor is presenting on a rare disease trial, the entire team could benefit from an outside expert to attend as well.

Similarly, the FDA will bring key staff to the meeting, including:

Medical reviewer
Biostatistician
Clinical Pharmacologist

Ultimately, through each of these meetings, the FDA is there to guide sponsors on how to move forward with their program. It’s imperative for sponsors to leave each meeting understanding the FDA’s guidance and how it impacts their program, including any adjustments needed to take place in order to move forward and conduct successful clinical research.

While the FDA provides guidance to sponsors, there are nuances to effective communication derived from experience. This blog series presents an experience-based review of best practices for FDA communication across pivotal milestones in the drug development lifecycle, diving deeper into each formal meeting between the two entities.

In this increasingly digital world, we have to remember data is now available in many different medians, including paper. When we think of clinical trials and the critical data we collect, we have to be very cognizant of how the data is obtained, as well as how data integrity is maintained throughout its lifecycle. This includes all phases in the data lifecycle, from generation and recording through processing (including analysis, transformation, or migration), use, data retention, archive/retrieval, and destruction.

What is Data Integrity?

The Food and Drug Administration (FDA) uses the ALCOA acronym to define expectations for data, indicating data should be:

Attributable
Legible
Contemporaneous
Original
Accurate

The Medicines and Healthcare products Regulatory Agency (MHRA) additionally refers to “ALCOA+.” The “+” stands for “complete, consistent, enduring, and available.” The MHRA GXP Data Integrity Guidance and Definitions focuses on promoting a risk-based approach to data management, including data risk, criticality, and lifecycle.

Data integrity is agnostic of the system used and may be collected via electronic means, on paper, a hybrid of the two, or other imaging techniques such as photographs. Instances of data integrity failure can occur at almost any point in data creation or processing in a clinical trial, so you need multi-dimensional strategies to help prevent and mitigate data integrity issues.

Assuring data integrity throughout clinical trials requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.

Why Data Integrity is Important

Ensuring data integrity is an important component of the pharmaceutical industry’s responsibility to protect the safety, efficacy, and quality of drugs, as well as a regulatory authority’s ability to protect public health. Data integrity is critical throughout the “data lifecycle,” from the initial creation of the data through any transfers, replication, or reporting stages. Data is critical to decision making, therefore, it is imperative for organizations to have systems and processes in place to assure data integrity.

How to Ensure Data Integrity

Having procedural documents, such as policies, standard operating procedures (SOPs), and risk management plans for data management available is important. However, you also need to have systems and processes in place to ensure everyone knows their role in maintaining data integrity throughout its lifecycle. The World Health Organization (WHO) draft guideline on data integrity recommends having governance control strategies in place using quality risk management principles, which enables error detection, lapses, and omissions of results and data during the data life cycle. Controls may include procedural controls, organizational controls, and functional controls.

These controls include:

Data risk management plans
- What to assess
- When to assess
- How to assess
- When/how/who to report outcomes to
Data integrity risk assessments
- Vendor selection and oversight
- Data monitoring
- Use of statistical methods for detecting data issues
- Validation processes and documentation
Data governance:
- Data ownership and accountability throughout the lifecycle
- Training in the importance of data integrity principles
- Accountability, oversight, and escalation of data integrity concerns; CAPA management
- Ready availability and direct accessibility to agreed upon individuals (e.g., regulatory authorities)

Ensuring data integrity practices are in place is critical to the confidence in the data generated and maintained to ensure participant safety and being able to reconstruct clinical trial activities. It minimizes risk to regulatory authority inspectional observations.

Consistent and effective training delivery across sites is challenging when addressing a global clinical trial with double or triple-digit site numbers and site staff located worldwide. Clinical trial training is an essential step in a successful study, requiring an explanation of the complex protocol, International Conference on Harmonization (ICH) good clinical practice (GCP), regulatory matters, and descriptions of challenging concepts. However, there are simple features applicable to all gold-standard eLearning development that can reduce manual work and make clinical trial training more compelling and improve compliance rates.

Know Your Target Audience and Keep them Motivated

A good eLearning course doesn’t simply provide essential information, it needs to motivate the end user. In the context of clinical trial management, site staff require training to ensure they know how to safeguard study participants and mitigate deviations. Site staff work in a highly fast-paced environment, often switching tasks at short notice to address an unscheduled item. It’s important to recognize interruptions will occur and to break down study protocol training into bite-sized chunks. Keeping this in mind ensures the content resonates for your busy target audience.

Storyboard Your Ideas

Your eLearning course must convey the essential aspects of complex, text-heavy protocols and present them in a fluid and easy-to-understand visual format. Storyboarding is the best way to achieve this. It will encourage teamwork by enabling staff to convert the content into animated graphics to ensure each scene and the overall message is clear for the learner. Take the time to think about the story you are telling by understanding the important aspects of the scene and how to sequence them. With storyboarding, everyone on the training development team has strong visualization from the beginning of how the final product will look and how the course will flow screen-by-screen.

Resist Putting Everything On-screen

With the best intentions for audience engagement, it can be tempting to throw everything into a course, but that may dissuade or distract your site audience. Generally speaking, too much media overwhelms. Don’t distract the learner from your key message; make sure what is on-screen is clear, concise, and visually appealing. Remember: short and easily digestible training is best since the average person’s attention span is limited.

Optimize for Mobile

In today’s world, learners are constantly connected via smartphones, tablets, and other portable devices. Optimizing your courses for mobile platforms is critical to ensure your target audiences can complete training on the device of their choice when they choose to. Additionally, over 80% of physicians now use smartphones for professional purposes.¹For this reason, it is essential to keep mobility in mind when selecting the type of authoring tool you’ll use to create and deploy your course.

Make the Effort Worthwhile for the Learner

Inherently, we all like to receive something to acknowledge our success and to make the effort feel worthwhile. Providing certification is a simple but tangible way of doing so. A certificate provides your learners with a sense of accomplishment and acts as an essential inclusion document in the site master file. These can be set to generate automatically when a course is completed.

Survey Your Learners

After an eLearning module is completed, surveys are a great way to gather honest, actionable, and insightful feedback. Always adopt a continuous improvement attitude to the eLearning you create to stay ahead of the curve and ensure your courses deliver as you want them to. Always remember: as with the eLearning itself, know your audience. Our target audience is busy healthcare and research professionals, so develop surveys that are short and to the point.

References: 

http://www.emarketer.com/Article/Smartphones-Enter-UK-Physicians-Offices/1011264

At Advarra, it’s our mission to ensure safer, smarter, faster clinical research every step of the way in the research process. One example of this approach is the way we promote and encourage research sites to own their technology, allowing them to ensure their solutions meet their specific needs and adhere to site workflows. How do we make this happen? This article outlines Advarra’s collaborative approach to the software development lifecycle (SDLC) process and how sites benefitted from it.

Encouraging Open Communication to Enhance Collaboration

Communicating directly with technology customers provides us with a better understanding of site needs and challenges at a granular level. A unique way the Advarra product management team accomplishes this is through regular “collaboration calls.”

Led by product managers, Advarra’s monthly collaboration calls involve dozens of customers providing input on how to further develop the product’s roadmap to not only fit their needs, but enhance research operations industry-wide. These ideas are then developed further and brought back to collaboration calls for community buy-in, evolving our product with direct input from our customers.

Another way to encourage communication is through forums, such as Advarra’s Onsemble Community. While community members have an always-on platform to ask questions and spark conversation, they also have the opportunity to meet, learn, and collaborate twice a year at the Onsemble Conference. During the Virtual 2021 Spring Onsemble Conference, panelists from Lifespan Cancer Institute, Duke Cancer Institute, Karmanos Cancer Institute, and Duke University provided insights about their experiences using Advarra’s eRegulatory Management System. A key theme woven throughout the presentation was the importance of collaboration between their organizations and the Advarra team. Not only did panelists feel empowered to suggest ideas and help them come to fruition, but it helped them to better understand product capabilities. Having an open communication relationship with a vendor enables sites to fulfill their needs and use the software to its fullest extent, and opens the door for a single organization—or even a single person—to provide insight to shape a product used industry-wide.

Encouraging Site Centricity to Advance the Industry

As we continue to move forward as an industry, site centricity and its impact on clinical trial success is more important than ever. Site centricity benefits everyone, including sponsors and contract research organizations (CROs), by focusing on empowering those closest to the research and participants. By developing workflows and technology solutions to address challenges faced by sites, we can enable more efficient trials, improving the participant experience and ultimately delivering treatments to market faster.

When sponsors and sites begin to work together and aim to become more site-centric, it allows sites to flourish. Through this approach, sites using technology have built top-tier programs at their institutions. 86% of National Cancer Institute (NCI)-designated cancer centers and 55% of clinical and translational science award (CTSA) programs use Advarra’s technology. By working together with the site in mind, it not only enables a more efficient SDLC process, but resulted in successful clinical trials, positively impacting sponsors and CROs in the process as well.

When it comes to selecting a clinical trial management system (CTMS) for your research organization, there dozens of factors to consider before making your final decision. Does the pricing model make sense for my company? Will the system provide a fast return on investment? Does the system provide the necessary functionality to get the job done?

All of these relevant questions to ask, but there are a few more questions to consider during the selection process. While the system itself is the often the most exciting part of the process, failing to ask questions about other aspects of the solution provider can help prevent you from selecting a vendor that is not a good fit for your company. Here are four questions to ask during the selection process to offer more insight into your future success with the selected vendor.

What is your Customer Retention Rate?

Understanding a CTMS provider’s customer retention rate is critical to ensuring you pick the right system. CTMS providers often highlight about how many customers they have, but don’t readily share any information on retention. It’s important to understand this because it indicates how much value the vendor brings to the table for the research organization. If a large number of people sign up but then don’t renew their subscription, it should pose a red flag. What is happening after the sale that is causing discontent? Was the system oversold on its capabilities? Is support not available?

How Frequently do you Release Software Updates?

The past few years have brought near-unprecedented change to the clinical research industry. For a CTMS system to continue to properly serve a research organization, it must adapt to meet the ever-changing needs of researchers. In today’s fast-paced world, CTMS vendors need to be quick in order to provide the best experience for researchers. This is why it’s critical to understand the release cycle for the CTMS vendor you select. Make sure your selected vendor releases three to four updates per year. This way, changes to the industry are accounted for in a very short period of time.

What New Functionality are you Working on for Future Releases?

Not only should a CTMS vendor provide releases on a regular schedule, but the content of those releases should be relevant to the users. During the CTMS selection process, be sure to ask what the company is currently working on for future releases, and how they determine which features are included in a release. This is often a good indication of your vendor’s marketplace awareness. Additionally, it helps ensure you select a vendor who understands trends and develops software to help keep you successful in the ever-changing research industry.

How Many Service and Support Personnel do you Employ?

The level of customer support your CTMS vendor provides to its customers is almost as important as the system itself. If you face a problem or have a question, you want to know you will receive answers in a timely manner. This is why it’s important to ask how many service and support personnel the CTMS vendor employs. There should be a sufficient number of staff available to handle calls in a timely manner and ensure users are up and running in no time.

Ultimately, thinking of questions such as these when choosing a vendor will help your organization in the long run. By understanding how a vendor holistically could fit into your organization, you are poised to select the best one for your organization’s needs.

Phase I research is a crucial part of drug and therapy development. Because it differs in important ways from later phase research, Phase I studies raise unique challenges, in both their design and implementation as well as for the institutional review board (IRB). Proactive strategies for identifying and addressing these challenges can enable ethical IRB review and timely study implementation.

What is Phase I Research?

Phase I studies are typically the first studies conducted in human beings and most often involve a drug or biologic. Perhaps the most common objectives for Phase I studies involve establishing parameters for an investigational agent’s pharmacokinetics (how it is absorbed, metabolized, and excreted by humans) and pharmacodynamics (the agent’s effects on humans, including its mechanism of action). Studies with other objectives, such as establishing bioequivalence and/or bioavailability between a reference and investigational product, may also be considered Phase I research.

While Phase I studies will under certain conditions be conducted in sick patient populations, oncology being the most notable example, much of Phase I research is distinguished by limiting its study population to healthy volunteers.

In addition to their unique objectives and healthy study populations, Phase I studies can also be distinguished from a participant perspective by the types and frequency of study procedures involved. Many Phase I studies require frequent blood collection and monitoring, often necessitating inpatient stays for participants at dedicated Phase I units, sometimes for extended periods of time.

Challenges with Phase I Research

Participant safety

Because Phase I studies often administer interventions that have not been evaluated in humans before, extra attention to participant safety is warranted. In most cases, the intervention will have been evaluated in animals prior to Phase I use, and the FDA has standards for moving from animal to human dosing to ensure an adequate safety margin, which sponsors and the IRB should ensure are met.

In addition, Phase I studies evaluating an intervention for the first time in humans are usually well-advised to employ sentinel dosing. This means administering the first dosage, and in some cases each new dose level of the product, to a small number of participants and allowing sufficient time to pass to detect adverse events before more people are exposed.

Sentinel dosing ensures that, should the intervention be poorly tolerated, the number of participants adversely impacted will be minimized. Intensive monitoring is also needed to ensure that adverse events are detected and addressed in a timely manner.

Payment and house rules

Phase I studies enrolling healthy volunteers often offer more robust payment and incentive for participation than research involving sick patient populations, where the prospect of receiving a new investigational treatment may be sufficiently motivating.

While there is nothing inherently problematic about payment, clear compensation schedules are paramount for both participants and the IRB. Such plans should include the amounts and timing of payment, whether and how payment will be pro-rated in case of early participant withdrawal, information about any completion bonus, and the conditions under which full payment will be made (e.g., if full payment will be made when a withdrawal is the result of a side effect from the test agent).

Many Phase I facilities have “house rules” that participants must follow to remain in studies. IRBs should be aware that house rules may contain information pertinent for certain aspects of their review and may request them as needed. Information that is contained in the house rules generally need not also be reiterated in informed consent documents.

Operational challenges

In addition to features of Phase I research that pose challenges for IRB review, Phase I studies also pose unique operational challenges for sponsors, CROs, and sites. Many Phase I studies are on tight timelines and face pressure to recruit and schedule participants as quickly and efficiently as possible. This makes identifying and proactively addressing the ethical and regulatory challenges posed by Phase I studies crucial so that IRB review does not needlessly become the rate-limiting step for Phase I studies.

Balancing Ethics and Efficiency

Appreciation of the unique features of Phase I research can help build a research ecosystem that meets demands on efficiency without sacrificing quality ethical IRB review. IRBs should clearly delineate their standards for review of Phase I research to sponsors and sites, including expectations around the common sticking points discussed above (e.g., when sentinel dosing will be expected; policies relating to payment and completion bonuses; etc.). Sponsors and sites should take that information and build protocols and IRB applications that proactively address the ethical and regulatory features of Phase I research. This can mitigate the need for IRB deferrals and speed review times while assuring ethical standards are maintained.

Decentralized clinical trials (DCTs) are becoming one of the most dynamic ways to conduct clinical research. The ability for research sites to deploy remote trials elevates opportunities easily and effectively, priming them for increased sponsor awards and participant engagement. In order to capitalize on all the benefits DCTs have to offer, clinical research sites must embrace the myriad of technologies making remote trials possible. This blog covers three must-have decentralized trial tools to efficiently and compliantly implement remote modalities at your organization.

Remote Workflow Capability

A main concern regarding successful remote trial work is preserving source document workflows, critical approval processes, and CRF completion. If a research site doesn’t have processes or technology in place to address these concerns, sponsors may not select them for remote research. Even if a site transitioned to mostly remote workflows, leveraging tools like a clinical trial management system (CTMS) or an eRegulatory management system demonstrates a site’s ability to effectively and compliantly manage remote workflows. However, the process of transitioning to remote data capture and case report form (CRF) completion is challenging. In order to keep the process moving and provide timely access to avoid unnecessary delays to remote principal investigators (PIs) and monitors, sites need an effective eSource system. eSource not only captures screening and visit data effectively, but also empowers team members, reviewers, and approvers working remotely to leverage 21 CFR part 11 compliant eCRF workflows instantaneously.

Electronic Consent Management

Maintaining updated hard copy consent documents are complicated for site-centric clinical research models, but they are especially impractical for remote trial work. Electronic consent, also known as eConsent, systems digitize the process of facilitating and obtaining initial and ongoing informed consent. While this is a necessity for all trials, it’s especially critical when participants never physically enter a site. Entering consent forms directly into the system increases information accuracy and completeness, helping boost sponsor satisfaction and ensure audit preparedness. Due to its dynamic digital nature, eConsent systems provide diverse engagement tactics via images, audio, video, and other eLearning elements to ensure informed consent and increase participant comprehension. Digitizing the process of obtaining consent can increase the chances of a positive participant experience and boost retention.

Video

Remote trials help remove a significant barrier to participating in research: frequent travel to a brick and mortar research site. However, requiring fewer in-person visits opens the door for improved research access and new participant engagement tactics. In order to maximize the remote participant experience, decentralized trials require technology to facilitate virtual visits, designed with both sites and participants in mind. Secure video conferencing is a critical component for remote trial model success, as it allows sites to complete study visits virtually, increases site revenue, and reduces in-person monitoring costs. Convenient video solutions don’t require special app downloads or installation, making it easy for participants and clinicians to gain access. They should also support multiple attendees to join, in case participants have home health care or family members who are involved in their trial participation. In addition, integrated video capabilities with your Clinical Trial Management System (CTMS) or EHR system further centralizes your workflows and eliminates multi-system visit data entry.

Explore more resources about how these tools can help your site succeed in the new remote research landscape:

As the clinical research industry becomes more technology-centric than ever before, it’s becoming more common to work with connected technology platforms to streamline studies. One such example is working with integrated eSource, electronic patient-reported outcome (ePRO), and electronic data capture (EDC) systems. What are their roles in research? Similar in many ways, how do they differ?

eSource

Any data initially recorded in electronic format, the Food and Drug Administration (FDA) guidance documents defines eSource as “any combination of text, graphics, data, audio, pictorial or other information represented in a digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system.”

By using eSource, researchers have the ability to produce consistent and legitimate data, as source data will be electronic from the start of the research process. Since data will be electronic, this considerably reduces the risk of submission errors. Additionally, source data are easily made available to sponsors and contract research organizations (CROs) for remote monitoring, as opposed to scanning in paper sources. Because of this, it’s becoming more common for sponsors to require a remote monitoring solution.

An example of eSource is an electronic case report form (eCRF), which holds data collected by a clinical investigator, a medical device, an electronic health record (EHR), automated laboratory reporting systems, or other forms of technology. When research staff use eCRFs, they’re often completed via EDC system.

ePRO

When participants use ePROs in trials, they have the ability to answer questions and give reports throughout a trial. These are usually done over devices such as a tablet, a smartphone designated for a study, or through an app on a personal device.

There are many benefits to adopting an ePRO technology. Participants typically prefer to electronically report their progress as opposed to keeping a paper diary, as it’s usually quicker and more convenient to report on a device than write things down manually. However, ePROs benefit research staff as well. By centralizing all patient-reported data electronically, it will lead to consistent and more reliable data than paper sources could provide. Using ePRO also reduces duplicate data entry by the staff since data are collected electronically from the start.

EDC

As participant data are collected throughout a trial, data are stored in an EDC software, keeping everything in one place. EDCs are used by sponsors to collect the key data needed for clinical trial analysis and reporting. If a site is running an investigator-initiated trial (IIT), it may implement both EDC and eSource together to streamline data collection.

As a way to help with intricate or simplistic studies, an EDC can help sites, sponsors, and CROs achieve success through:

Access to data
Data security
Accuracy
Greater organization
Cost-effectiveness
Compliance

Understanding Their Differences in Research

While each of these elements work to enhance research operations, there are differences among each of them. Owned by the site, eSource is designed to collect every piece of information researchers may need from a standard of care, research, and operational workflow perspective. An example of this is lab data. In eSource, researchers typically collect details such as a participant’s initials, their date of birth, the date and time of the sample collected, lab results, etc. Through eSource, researchers have a very detailed outline of how a study is going.

On the other hand, EDC is typically owned by the sponsor of a research study or a site if they are conducting an investigator-initiated trial (IIT). Additionally, EDC is a subset of eSource because it doesn’t collect protected health information (PHI). When collecting lab data, an EDC only needs the date and time of collection and the test results; not as thorough as researchers collecting eSource.

Used as a way to eliminate duplicate data entry, ePRO is considered to be another type of eSource. While eSource itself is collected by researchers, ePRO is generated by the participant directly. An example of this is a participant completing a survey to provide feedback about the study.

Even though there are differences between eSource, EDC, and ePRO, each element works to enhance operations and provide a more thorough understanding of how the study is going as a whole, from data collected to participant experience.

Research organizations utilize a variety of medical professionals to conduct successful clinical trials. Two of those positions are a medical science liaison (MSL) and a clinical liaison. Both play a crucial role in keeping research organizations running smoothly, while taking on separate roles and responsibilities.

MSL Responsibilities

According to the Medical Liaison Science Society, a medical science liaison is a healthcare consulting professional within the pharmaceutical, biotechnology, medical device, contract research organization (CRO), and other healthcare industries.

The main purpose of their role is to establish and maintain a peer-to-peer relationship with leading physicians at academic medical centers (AMCs) and clinics. With a more outwardly focused role, MSLs typically deal with products utilized by physicians already on the market. The MSL will take the information the organization learned during the clinical development process and will share it with the physicians. This establishes the relationship and gives physicians an understanding of how this new product benefits their patients. They can also get the opinion of those physicians on the product, and take those ideas back to the clinical development organization to further improve their invention.

MSLs also work very closely with sales teams; since they are the ones promoting the new product to potential buyers, the MSL has to train and educate the sales team on the product’s functions and the benefits they can bring to patients. A MSL typically works with physicians on a more clinical academic level, while the salesperson deals with the day-to-day sales processes. They also help oversee clinical trials that showcase how the product works as safely and effectively as it was shown to work in the original trials.

Clinical Liaison Responsibilities

A clinical liaison is another great asset to a medical facility or healthcare organization. They handle a variety of tasks related to communications and general growth, and provide a range of services, from technical handling of new patient processes to more general community outreach. Clinical liaisons are typically registered nurses or licensed practice nurses with strong clinical experiences. They serve as an advocate for patients during the pre-admissions process, continuing until the patient is discharged from the facility. A clinical liaison is responsible for maintaining communication between the healthcare provider and the patient, as well as ensuring the patient understands and consents to the procedures conducted. They have a significant role in evaluating patients by conducting a thorough review of the patient’s medical records, medications, treatment plans, and insurance availability. The main goal of a clinical liaison is to ensure the patients understand procedures, the paperwork, and the entire clinical research process

Teaming Up to Deliver High-Quality Clinical Trials

Both medical science and clinical liaisons are important members of a clinical research organization. While they serve different roles, their primary focus is to provide patients with the most reliable and high-quality clinical trial experiences possible.

The clinical research landscape is likely forever altered by the COVID-19 pandemic, especially regarding trial continuity and the potential for business development. According to the Lancet, 80% of non-COVID trials were suspended, forcing all major pharmaceutical companies to delay current or planned trials. In May 2020, BioPharmaDive reported nearly 240 trials experienced disruptions, which lead to potentially devastating financial gaps for research companies. While COVID-19 trials made up for some of the losses and other trial work is now mostly back on track, the situation underscored the need for constant attention to the business pipeline.

Keeping trial types and designs diverse, as well as understanding important metrics, helps research companies mitigate the negative effects of trial delays. Increasingly, sponsors want to ensure performance is monitored and reported upon accurately. Having the right technology to provide sponsors with predictability and reliability sets an organization apart, leads to growth, and helps sites secure a position as a loyal partner of choice. Through this, sponsors should understand how sites can provide predictable, reliable trial results. A site can further differentiate and demonstrate how their team approaches enrollment – especially how they track, record, and organize data.

Another ramification of COVID-19 trial work is the demand for increased speed to market from sponsors and communities. The time from the start of the pandemic to the approval of a vaccine was remarkable, but also will likely affect the public’s view of what is possible. Not only will sponsors look to partner with clinical research sites to offer more efficient trials, but the public will also likely demand quicker cures to known diseases.

The first hurdle of speedier trial execution is having the right recruitment tools in place, including social media integration for campaigns. Recruiting with a fully capable clinical trial management system (CTMS) also allows sites to track metrics easier and verify study participant enrollment goals are reached. Tracking recruitment efforts and outcomes can play a strategic role in deciding how to recruit for future trials. Perhaps more importantly, this encourages early enrollment for participants in studies still in the request for proposal (RFP) process.

Easily and effectively deploying remote trials will elevate opportunities for research sites and prime them for increased sponsor awards and participant engagement. In order to capitalize on all the benefits of these trials, clinical research sites must embrace the myriad of technologies making remote and hybrid trials possible. These include texting, video, electronic consent, remote monitoring, and decentralized workflow capabilities.

Maintaining a robust clinical trial pipeline for any type of trial a sponsor may offer includes tracking data collection, analytics, and reporting supported by comprehensive CTMS and eClinical systems. Successful sites have the tools and understand how to measure the return on investment (ROI) of these investments, deploying them thoughtfully to align with growth and revenue goals.