Collaborating with Research Sites: Best Practices for Site Selection and Study Startup
The study startup process is a critical point in research, and oftentimes, can make or break a study’s success. Sites, sponsors, and contract research organizations (CROs) must work together to ensure a streamlined startup process, but oftentimes, there are hurdles to overcome. Understanding the current state of study startup often helps shed light on methods to implement for process improvement.
Identifying, Qualifying, and Selecting Sites
A key component to improving the process is site selection. During this process, communication and personalization are key. Sponsors must be able to communicate with a site’s central office, rather than just specific people on a trial, such as principal investigators (PIs). This encourages the stakeholders most prepared to act and manage resources are informed of upcoming trial opportunities.
Due to a lack of centralized information and access about certain research sites, sponsor study teams will produce and distribute site feasibility questionnaires (SFQs) to sites they may have already engaged or received responses from in the past. While easier for sponsor study teams in the short term, it creates significant redundancies and administrative burdens for sites. Many questions are asked multiple times, and there’s a lot of back and forth with sites and sponsors to ensure feasibility. Leveraging what’s on file to reduce the amount of time you’re asking sites to fill out questions will go a long way.
Gained efficiencies in the SFQ process are needed – low site response rates exemplify this, as well as sites desiring to receive more study opportunities. Site respondents have various opinions on how repetitive SFQs are within the same sponsor, with 54% stating at least half the questions are redundant with previous questionnaires they have received from the same sponsor. This high rate of perceived redundancy, combined with the response from our sponsor respondents indicating 76% of them keep a repository of answers from previous SFQs, provides an opportunity for the industry to streamline efforts by better utilizing data already collected.
Budgeting, Contracting, and Managing Essential Documentation
The information and document exchange requirements of any research program can be enormous. Generating and exchanging documents through a standardized and repeatable process makes it much easier to systemize programs for faster startup.
A standardized approach to study startup lays an essential foundation for efficiency. Current processes in contracting and budget negotiations require most study and site teams to renegotiate the same terms across each individual trial. Creating a master clinical trial agreement (CTA) with regular partners will streamline processes and instill a sense of trust between stakeholders.
For example, when negotiating a study budget, if your site is charging a specific amount for a procedure or visit and negotiating with the sponsor, it’s important to be as detailed as possible. There are discrepancies between similar procedures and price differentials to consider, and the clearer a site can be about how much money they are asking for and why, instills a sense of transparency between them and sponsors, since everyone is on the same page about what is being funded.
Beyond budgets and contracts, a lot of additional documentation is exchanged during study startup, including essential regulatory documents. This may come in the form of email chains or paper documentation constantly needing updates. Utilizing purpose-built platforms to manage, exchange, and collect various critical documents in a centralized manner, rather than manual workflows required for managing email or paper, can go a long way for your teams during the study startup phase.
Site Initiation, Training, Transparency, and Reporting
As the study activation process leads into initiation and training, organizations are often closing the loop on many activities happening within the startup process – sites are selected, documents are signed, and operations are moving. At this stage, it’s imperative to have proper resources and tools prepared prior to the site initiation visit (SIV).
Typical site initiation activities such as investigator meetings (IMs) and SIVs should be supplemented with engaging training materials and a clear agenda. In addition to study-specific resources, sponsors and sites can streamline the training processes by accepting training programs of others on research requirements like good clinical practice (GCP) and store those certificates for future studies.
As sites and sponsors work together to uphold transparency and reporting across study startup, being able to see what’s happening at sites from an activity perspective is very helpful. Sponsors should ask questions such as:
- Have sites received our amendment to the protocol?
- How many sites have completed their training? Are they prepared to conduct the study?
- How many patients have been pre-screened? Are there any enrollment criteria to adapt?
Although notifications can keep sites on track, sponsors must realize more isn’t always better. Finding the right balance of updates to send to sites will be better than sending too much, or none at all. Also consider who you are sending notifications to – are they the right people who need to see them? Communicating expectations with sites – and being open to receive feedback regarding notifications and communication as well – will only strengthen your relationship with your sites in the long run, which leads to better study startup processes.
To learn more site-centric and collaborative strategies that will improve your research operations, watch our on-demand webinar, “Reducing Site Burden throughout Study Startup”, featuring a panel of industry peers of life sciences and sites alike.