In Advarra’s first Fireside Chat, CEO Gadi Saarony met with Deb Tatton, Parexel Senior Vice President of Global Clinical Operations, for a video conversation about the future of clinical trials and site engagement. Almost 600 clinical research professionals joined the virtual event to hear about possible ways sponsors and CROs can work more collaboratively with sites to improve study startup and address the changing clinical trial landscape. In this blog, Deb and Gadi discuss the evolving role of technology in clinical research. Read part 2 of this Q&A for their thoughts on ways to improve site and patient engagement.
Q: What new skills should people working in the clinical trials space look to develop as technology begins to play a bigger part?
A: Many new technologies to manage clinical studies have been built with the end user in mind: intuitive interfaces, associated self-paced eLearning modules, and often help desk support included. That said, establishing basic competencies with mobile devices and apps, online financial activities (e.g., paying bills, depositing checks), and videoconferencing and online chat tools will help research professionals more comfortably adapt to new devices and tools. Also important to note is that the ability to trend and interpret data, use visualization tools to present information, and communicate clearly and succinctly are critical to effectively leveraging technology.
Q: Is there a movement to harmonize technology/software used by industry sponsors and contract research organizations (CROs) (e.g., electronic data capture [EDC], etc.)?
A: While some groups have discussed the benefits of this harmonization, we have not yet seen any major industry movement. Certainly, we are seeing efforts to harmonize data standards and a push toward common “e” templates. But with the emergence of so many new technologies and technology providers, harmonization is not currently on the near horizon. We believe as “winners” emerge, and smaller players merge into larger players, some standards will materialize. Pressure from industry groups such as CDISC may also produce some harmonization, but for now, there seems to be a greater push for interoperability and creation of application programming interfaces (APIs).
Q: What will be the new norm for on-site vs remote monitoring? Will sites be able to budget in contracts for both remote and on-site visits?
A: We expect hybrid approaches, whereby studies have a combination of remote and on-site visits, to continue. In the future, more trials will have decentralized components with a higher percentage of monitoring visits performed remotely. Site monitors’ ability to perform more monitoring activities off-site will increase, thus reducing site time for on-site visits, through things like remote access to electronic health records (EHR), eRegulatory systems, and CTMS; the use of wearables; and wider adoption of risk-based monitoring applications. Other technologies allowing the monitor to scan the site for compliance and track drug supply, for example, will also change the dynamics of site visits.
Sponsors and CROs typically do not set up their site budgets and contracted payment terms based on CRA visit types but rather on patient screening, enrollment, and patient procedures so we don’t anticipate significant impact on site payment budgets.
Q: What is needed from CROs and sponsors to embrace real-time and real-world patient data derived from wearables and other remote data capture systems (including electronic patient-reported outcomes [ePRO])?
A: Primarily expertise. You make a great point about the validation requirements. Parexel’s Scientific Data Organization is building strong capabilities to help select the right wearables and process the resultant data to satisfy protocol objectives. The key is making sure we understand the purpose of the data. Some devices are not quite suitable for primary endpoints, but the availability of suitable devices will change rapidly. In addition to domain expertise, we must also leverage expertise in areas like data integration, regulatory and IRB considerations, logistics (in the case of wearables and mobile technologies), remote training, and data privacy. Both Advarra and Parexel recognize the changing clinical trials landscape and have added expertise in these areas.
Q: Considering cultures in the workplace, how are clinical trial staff coping with technology changes?
A: This can be challenging for different countries/cultures. Not only are there different regulations for what technologies can be used to support remote activities, there are also local processes more dependent on in-person interactions. So, for some cultures, the technology changes are easily adopted, and for others, it takes more time to alter processes, seek approvals, and implement training to support the new use of certain technologies. In general, the adoption of any new technology involves a learning curve. At first, the burden on site staff actually increases, but over time, that burden decreases. In fact, these technologies should free staff to focus on research and high-value activities. Providing staff with IT experts who understand both technology and the staff’s day-to-day work is valuable.
Q: What are sponsors going to do about data integrity when the pandemic has changed the way data was collected (visits, assessments, etc.)?
A: Most if not all sponsors and CROs are currently conducting full project assessments to ensure they have evaluated and documented all of the risks and deviations that occurred as a result of COVID-19. In some cases, the deviations may require a protocol amendment to ensure study integrity remains intact. The protocol amendments will follow the required approval or acknowledgement process defined by country-level regulatory authorities and site-level ethics committees. Additionally, clinical staff can use technologies to analyze data and identify outliers and data risks.
Q: Can you outline the new technologies that are critical for success during this virtual era?
A: Allowing patients to participate in clinical trials from their own homes does require some novel technology solutions. The primary and core applicatoin is ePRO. This technology is used to collect data directly from the participant (e.g., questionnaires and pain scales), typically on a smart phone. Additionally, eConsent is important, allowing remote patients to consent to clinical trial participation from the same device. Telemedicine (HIPAA compliant) video calls are also an important technology, to allow face time with medical staff for patient visits. Lastly, wearables (devices collecting data from the patient while they are at home) will become a more critical part of decentralized trials, as these devices improve.
Q: Have sponsors and CROs modified their site selection criteria to cope with current conditions?
A: Most sponsors and CROs are now carefully looking at technology capabilities as part of site selection, whether for telemedicine, virtual studies, or remote access to site documentation. This is to ensure proper mitigation plans are in place to better help with future unanticipated events like COVID-19, enable better patient engagement, prioritize clinical research associate (CRA) time on-site for tasks that cannot be done remotely, and leverage the enabling technologies that already exist. In some cases, the site selection process, including qualification and initiation visits, can be performed remotely by leveraging tools and technology to facilitate communication and data gathering.
For more of these thought leaders’ perspectives on the changing clinical trial landscape, watch Fireside Chat: The Future of Clinical Trials and Site Engagement.