The Sponsor Trap
As the sponsor company, you may be resistant to some of the ideas presented in this article. For the sake of your clinical trial, please read on with an open mind. In this article we discuss what not to do when working with sites, to ensure your trial has a smooth execution. The “Sponsor Trap” describes the mindset that sites work for you and your study, rather than recognizing that you and your study are competing for sites’ time and attention alongside many other studies. Don’t fall into the Sponsor Trap. Rather than nagging and micromanaging site staff, be upfront about the needs and burden of your study, and strive to give sites the best experience possible.
Here are some general principles to help you avoid falling into the Sponsor Trap:
Your study is one of approximately a dozen that each coordinator is working on. Said differently, there may be only a few hours a week that coordinators can dedicate to your study -- and those hours will occur only when their schedule allows. How can you make your coordinators feel as supported as possible, at the time(s) they need your support? Are you being respectful of their time by minimizing your ask?
Your study is one of a thousand things on the minds of investigators. While most have good intentions of enrolling into your study, you’ll have to compete for their mindshare. Can you design your device and your study to provide the smoothest and best experience possible? What makes your device/study clinically important?
Any activity that requires the site’s time should include compensation. Think about the effort that’s required to pre-screen patients for a study with stringent inclusion/exclusion criteria. Are you compensating sites for the time it takes to pre-screen patients for your study, or erroneously expecting that other study payments (e.g., startup fees or actual enrolled subject per-visit fees) will provide compensation for this time?
Shield sites from internal corporate pressures. See every ask of sites as potentially straining on the relationship, and as such, save your asks for the times that really matter. Is it worth pressuring a site to get activated before the holiday season when realistically they’re not going to enroll until mid-January anyway?
Consider two anecdotes from past studies we’ve worked on as examples of what not to do during your clinical study.
Anecdote #1: We once worked as FCEs on a study where the sponsor company contracted with a large CRO to manage site startup. The CRO employees were emailing and calling sites more than three times a week (in some cases, every day!) to check on the status of budgets, contracts, and IRB approval. When it finally came time for the SIV at one of the sites, the research manager commented that the constant badgering from the CRO was the worst study startup process they had ever experienced. The principal investigator was also standoffish, after hearing that the research staff were rubbed the wrong way. Needless to say, the site collected its startup fee and never looked at the study again, enrolling zero subjects (and quite possibly not screening a single candidate either).
We recommend avoiding that scenario by determining a mutually agreeable follow-up plan with site personnel. The Site Evaluation Visit (SEV) is a great time to discuss how they would like you to check-in about the activation process, and the Site Initiation Visit (SIV) is the ideal time to discuss how they would like you to check-in about screening and enrollment. For example, if the site says they expect the contract to take four weeks to finalize, ask if after four weeks have passed you can start checking-in with them once a week until it is complete. Also, rather than pushing for small milestones, like a signature on a form, keep the broader goal of on-time study completion at the forefront of your mind. Shield sites from internal pressures you are feeling from upper management. Patience and communication, rather than micromanagement, are instrumental to healthy and productive site relationships.
Anecdote #2: Our team of FCEs supported a trial in which the investigational product required preparation in the OR. During the study kickoff meeting, the Investigators and Research Coordinators were informed that mixing and preparing the product was “simple” and that detailed instructions would be given to site staff for reference. In reality, the process that was anything but simple, and sites were only given the small-print package insert as directions for use. Our FCE team spent many hours with the Sponsor and their graphic designer developing a laminated visual aid to assist the Coordinators and OR staff. In total, the preparation of the product and subsequent measuring of unused product added a significant amount of operating room time to the surgery, and also required the OR staff to reconfigure their workflow to accommodate the product. While this sort of thing is not unusual for investigational surgical devices, the mistake was that the Sponsor did not set expectations clearly in advance, resulting in frustration for sites early on in the study.
Communicate to your sites all of the things you’ll need them to do for your study well in advance of enrollment. In fact, expect anything that was not disclosed prior to and factored into budget negotiations to be de-prioritized by sites. If you ask sites to provide detailed data on their pre-screening efforts but did not include compensation for this in the study budget, expect very few sites to deliver on what you want (and rightfully so, as sites cannot work for free). And if the intraoperative requirements of your device and study are more onerous than what was communicated during activation, they may simply focus on enrolling into other studies.
As a team of consultant field clinical engineers (FCEs), we at FCE Source have unique insights into what does and doesn’t work when working with study sites. We help our clients avoid falling into the Sponsor Trap, which in turn helps them complete their studies in a more timely manner. Equally importantly, it keeps sites happy and forges a strong long-term relationship between the sites and sponsor. Consult with us before well before your trial begins to maximize your chances for a smooth rollout and execution. Contact us today at info@fcesource.com.