I was talking to a colleague who manages a study site about situations in which sites and sponsors might seem to be far apart and how that affects the clinical research enterprise. Most importantly, what, if anything, can be done in those cases?
The situation presents itself…
A common example this site manager cited is protocols that seem “unrealistic”. As sites should do, his site carefully considers whether their site could successfully conduct an upcoming trial when it is sent to them by a sponsor or CRO during the site selection process. After all, to be successful, the study must be a good match for the site just as much as the site must be a good match for the study.
Due diligence includes assessing multiple factors, including whether the site can perform the study per the protocol’s requirements, whether the site can access the target population, whether site staff with the right background are available, whether the budget covers the site’s expenses, and many other considerations.
If any factors are of concern, what do sites do? What can they do? Do they simply decline participation in the study? Do they do so without identifying the reasons why? How often do they accept the study without discussion of their points of concern, and do those in the end cause their site to not be able to successfully conduct the study? Why would they do that – what dynamics are in play that lead to this? With approximately 1/3 of sites performing poorly in trials they are selected to perform, what good does this do anyone? This is a loose-loose for both sponsors and sites. What course of action is best for all stakeholders involved?
Ask and you may find…
My colleague thought there was “nothing that could be done” but when I told him of solutions I have seen, he was both surprised and happy to hear of this. For example, if his site felt a protocol was “unrealistic” I explained what scenarios could be possible. By explaining to the sponsor that the site was interested in the study, but concerned because specific Inclusion or Exclusion criteria could make it difficult to identify potentially eligible subjects, the sponsor could address that challenge a number of ways that would make it more realistic for the site to participate. For example, when I managed studies at sponsor companies, we were able to take that type of specific feedback and find ways to mitigate barriers for sites’ participation, including:
- To address the fact that there would most likely be more screen-failures due to the protocol, sites would be reimbursed for more screen-failures than originally stated in the budget, and if more are needed, this could be approved after discussion with the sponsor.
- Since more time would be needed to recruit from outside the site’s database, time for recruitment activities would be reimbursed.
- Since different recruitment methods would be required than those usually used by the site, recruitment support would be available to the site, as well as extra funds for the types of recruitment activities needed.
My colleague was shocked, saying he didn’t know any of these actions were possible. It can’t hurt to try! The more detailed and specific your information is when discussing the feasibility of your site being able to successfully conduct the sponsor’s trial will increase the chances of the sponsor providing what is needed for a site that does such due diligence!
About the Author
Sherry Reuter is President of Sherry Reuter & Associates, LLC, a consulting firm that focuses on the conduct of clinical trials, Site Selection, Study Start Up, Training, and Patient Recruitment and Retention. Sherry may be contacted at sreuter@gwu.edu or 203.775.6031.
Image: Idea go / FreeDigitalPhotos.net
