Strong Site Relationships
Clinical sites that are highly engaged contribute more to clinical studies. This means higher enrollment, fewer deviations and queries, and a better relationship between the investigational technology and the end-users. So how does a sponsor company support sites to facilitate high levels of engagement? The answer is two-fold: (1) by cultivating strong relationships, and (2) by ensuring that the study protocol has been designed for executability (DFE). In this article, we focus on how to build strong relationships through a framework of support, with clear expectations, channels for communication, and tools for site motivation. More information about DFE can be found here.
Do you find it easier to work on something unfamiliar when you feel supported and empowered? Excellent site support starts with empathizing with the struggles each site faces as it learns to execute your trial. By periodically checking in with coordinators and investigators about their challenges and frustrations, you will learn how to provide support in specific ways that are meaningful to them. If they are struggling with a certain aspect of the protocol, perhaps there is a supplementary resource or tool that you can provide (see the FCE Source article on Supplementary Resources). And likely, if the resource or tool is beneficial for one site it will also help others -- increasing engagement for your study across the board. Another option is to establish a short bi-weekly or monthly call with each site individually to provide an opportunity for their voices to be heard (please just make sure to compensate investigators and coordinators for this time).
When a site has questions or needs assistance, the sponsor needs to function like a rapid response team. Communicating expeditiously with sites should always take priority over internal matters. We recommend providing a single primary contact for each site who is available to answer questions promptly -- someone whom the PI and coordinator have met face-to-face and feel comfortable opening up to. Preferably the primary contact is someone other than the monitor; while some monitors can develop strong ties with coordinators, the nature of the relationship often changes as the site’s work is checked for errors and monitoring reports are issued.
Establish the foundation for a strong relationship by listening, responding quickly, and showing a genuine desire to help.
Set Expectations (In Both Directions)
Sponsor companies have expectations of their sites, and conversely, sites also have expectations of sponsor companies. By discussing expectations early on, it shows a sincere willingness to invest in the relationship as you consider their needs as well as your own. Have you clearly conveyed your expectations of the site in terms of screening, enrollment, investigator meeting attendance, data entry, etc.? More importantly, have you asked sites of their expectations of you as the sponsor company? Sites appreciate prompt responses, assistance learning how to execute the protocol, and honesty about where the technology stands. The stage of development of your technology is important to share because the expectations sites have of your technology will influence how they respond to device malfunctions or troubleshooting. Strengthen relationships by clearly conveying and receiving expectations.
Share Findings and Request Feedback
Sites are not just enrollment and data generators; they are your research partners. Keep them engaged by actively sharing findings throughout the trial. Sites feel more empowered when they are able to see the value in the data they are producing and have an opportunity to share their thoughts. Sometimes due to the design of the study, data cannot be shared with sites until the trial has concluded. But is there anything you can share to help keep them interested? Case studies? Demographics? Discussing findings helps make it clear to sites that they are more than just cogs in the machine; they are research partners to your company. Conversely, keeping sites in the dark about findings while continually pushing them for enrollments often leads to study fatigue and loss of interest in the trial. Solidify relationships by truly treating your sites as research partners, and keep them engaged by sharing findings.
As you get to know each of your sites, note what motivates their performance. Common motivators include publication opportunities, contests between sites, collaboration on research with peers, awards presented at conferences, and adequate compensation for time spent on study matters. What motivates each site depends on the type of site and individual preferences of the investigator(s) and coordinator(s). For example, academic centers may be more motivated by publication opportunities than private practice sites. We recommend providing all sites with guidelines for co-authorship at the beginning of a study, to remove ambiguity about the process and ultimately help motivate certain sites to perform. When developing a contributionship policy, consider the recommendations from the International Committee of Medical Journal Editors (ICMJE) (link). Another thing to look out for is whether adequate compensation is being provided for certain time-consuming tasks. For example, if coordinators are having trouble regularly submitting screening logs, or investigators are not attending monthly calls, you may need to re-evaluate whether the remuneration outlined in your budget agreement adequately compensates sites for the actual time and effort they are investing. Finally, don’t forget to recognize sites for a job well done. Awards presented to individuals -- especially coordinators -- can go a long way in showing your appreciation for their hard work, and helps reinforce the relationship.
As the sponsor company, the relationship you have with each site affects their support of the clinical trial. Recognize the specific needs and challenges at each site, and work diligently to build relationships with investigators and coordinators. Engaged sites contribute more to clinical trials, and there is not a one-size-fits-all recipe for engagement. At FCE Source, we always stress the importance of relationship-building, and can help you develop a site engagement plan, train your site support team, or be your site support team. Contact us at firstname.lastname@example.org.