Do We Still Need To "Save" Our Sites?
By Dan Schell, Chief Editor, Clinical Leader
I’m not going to waste your time: The answer to my headline is yes.
Of course, not everyone would agree, and how we interpret “save” in this context is highly subjective. Still, I believe this segment of the clinical research ecosystem continues to get the short end of the stick in many ways, which, I guess, warrants my support of the metaphorical “saving.”
This topic is still top of mind for me since I just returned from my third Save Our Sites conference in San Diego. With approximately 500 attendees and more sponsors and exhibitors than the past three years, this show — and I would argue the sentiment around its eponymous mantra — doesn’t seem to be losing steam.
Budgets Remain Stumbling Block
If you’re one of those sites that doesn’t feel you need saving, then maybe think of SOS as “Strengthen Our Sites” or “Support Our Sites,” because, to me, I could sense undertones of each verb throughout the conference sessions — at least the ones on the first day when I was there (I couldn’t stay for the second day). This was really evident in the sessions related to budgets, including the one I moderated, “Strategies To Maximize Your Budget” and one led by MaryAnn Bowman titled “What Are You Worth? Budget & Compensation.” For the latter, since I was in the audience, here are some of the solutions/tips that stood out to me:
- Fair Market Value as Your Pricing Foundation
Document why your pricing is fair market value and sponsors will accept it 9 out of 10 times.
- The Clinical/Finance Disconnect is Costing You Money
Coordinators who don't know what's in the budget won't document correctly, and you won't get paid. Show your clinical team the procedures so they know what to check off.
- Hidden Protocol Traps
In COVID vaccine studies, coordinators had to call patients weekly — but nobody negotiated pay for it because the budget person never read the footnotes. Always have someone read the full protocol before finalizing the budget.
- You Are Not a Bank
Monthly payments with no holdbacks are now the industry norm. Push back confidently if a sponsor proposes otherwise.
Bad Experiences And Good Advice
In two of the sessions I attended, sponsors offered valuable insights, mostly regarding what sites should NOT do. For example, in one workshop held in a smaller room, we all sat at round tables and discussed questions we had for sponsors. Sean Cunningham from Takeda, Laura O’Donnell from GSK, and Robert Goldman from Contraline were the sponsors in the room who would wander from table to table fielding questions. This was a great example of the more personalized types of interactions this conference offered, and one I appreciated. Near the end, through prompting of the audience, the sponsor reps did come up with the following list of things that “turn off” a sponsor to a site:
- having to hound a site for info
- generic feasibility responses
- vague or exaggerated explanation of your site’s niche and expertise
- lack of info input into “free text” fields in the feasibility survey
The other session may have been my favorite, and probably for the wrong reason. This one, moderated by Marlyn Brookins, included three panelists who had sponsor experience and were asked to recount some of their “nightmare” experiences working with sites in the past. Their stories were entertaining, which is why this session was my favorite, but these anecdotes were so “out there,” that I’m hoping any real-life takeaways would probably be limited. For instance, Jess Thompson recounted how at one site, the employees were collecting their own urine and passing it off as samples from fictitious study participants. She also mentioned a site that was manufacturing meth. You know, common stuff like that.
Elizabeth Weeks-Rowe told us about the time when she could tell something was off at a pre-study visit. After repeatedly pressing the site's business development director, she uncovered that the original PI had been swapped to sub-I status specifically to hide a history of seven FDA inspections and multiple 483s. Needless to say, she didn't recommend the site, and the staff didn’t take that well.
Finally, Viviana Messick explained that at one of her sites, she discovered the PI and coordinator were a married couple who divorced mid-study. The coordinator fled to another city, leaving the PI's mother as backup coordinator and a cousin as lab manager. She spent weeks trying to get the estranged pair in the same room to close the site. The situation was compounded when three of the six enrolled subjects turned up with identical abnormal lab results at the same time — and the coordinator offhandedly mentioned they were all friends, strongly implying shared urine samples.
So, you see what I mean about takeaways? I guess you could say, don’t share your pee, marry your coordinator, obfuscate about your PI’s 483 history, or … cook meth?
Take Care Of Yourself
I saw a LinkedIn post that talked about the “vibe” at this conference being unique, and I’d agree. It might be the size of the crowd or their shared experiences, but there is definitely a more relaxed atmosphere at SOS complete with lots of hugs and “genuine” connections being made. I also liked the frequent acknowledgement that working at sites can be mentally taxing, and consequently, you get sessions like the one presented by Denali Rose called “The Breaking Point Behind The Breakthrough. Burnout in Clinical,” where she talked about ways you can … well … avoid burnout.
Working at a site or owning one is hard. Hell, any job in clinical research is hard! And until it gets significantly easier, I think there will always be a place for the SOS conference.