From The Editor | October 3, 2024

Want To Improve Study Startup? Get More Efficient

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By Dan Schell, Chief Editor, Clinical Leader

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John McAdory, MHA, VP of ClinOPs, CG Oncology

Even if I didn’t know ahead of time that John McAdory, MHA has a Six Sigma Green Belt, it would have been evident shortly after we started our conversation. Of course, it didn’t hurt that we were talking about finding efficiencies in clinical trials.

McAdory is VP of ClinOPs at CG Oncology, a late-stage clinical biopharma focused on treatments for bladder cancer. It’s a small company compared to some of the large CRO and Big Pharma companies he’s worked for in the past. But it’s that difference that has really given him the opportunity to use those Six Sigma skills he learned while getting his graduate degree in Health Administration.

He explained that he’s always been interested in the “big picture” idea of how we as an industry can reduce the cost of healthcare. We then narrowed that topic to some of areas he’s been focused on that will increase efficiencies (i.e., save time and reduce costs) in CG Oncology’s clinical study conduct. Ultimately, we landed on study startup. “It's always been the same; it’s inefficient,” he says. “Say you’re starting up a study and you have the same site working on two trials. Why are you asking them for the same information and materials all over again? Often, the answer is ‘Because that’s the way we’ve always done it.’”

He says that some of the information (e.g. a PI’s CV) that’s needed can already be found in the CTMS or eTMF. And if you just negotiated a CTA for the same site recently, is there a way you can reuse some of that data? Or would a master agreement be a better choice? Asking a site to collect redundant information is frustrating, especially since most stats related to feasibility studies say that sites already spend roughly 250 hours a year completing feasibility questionnaires. So, anything you can do to lessen that burden will be a welcome addition.  

HOW DO YOU STREAMLINE YOUR PROCESSES?

Interestingly, during our May 2024 Clinical Leader Live titled, “How Can We Improve Clinical Trial Feasibility Processes?, we asked attendees if they felt the feasibility process has improved in the past five years. Of the 79 attendees who answered, 61% said yes. I’m guessing, though, with a larger sample size, that percentage would be lower.

At CG, McAdory says they’ve focused on streamlining the feasibility process to include only the key questions they need to ask to decide if a site is a fit for a study. “We're trying to get our feasibility questionnaire down to 15 questions,” he says. “Often, sponsors will use feasibility surveys as data collection tools for not just the trial they’re recruiting for, but for future research. But if I stay focused on simply figuring out if they have the adequate experience and patient population to conduct the trial at hand, I don't need a five-page questionnaire to answer that question.” He says if you want that additional information for future trials, perhaps you do a separate phone call with the site rather than add another form for them to fill out.

Further efficiencies can be achieved, he says, if you use some type of site database that enables you to query based on the specific requirements of your study. With that capability, you can ask specific questions of a site for just the information you may need, such as a sub-I’s CV, eliminating the need for some massive binder of documents to be compiled. “The more targeted we get, the more efficient we get,” McAdory says. “It’s funny, I heard someone talking about the need for a site to have a -20-degree freezer. It seems like we’re always asking a site if they have one of these freezers, but if that info was already included in some site database, then that’s one less question we need to ask — and they need to answer. And all those little time savings add up, which can really help since we’re always trying to reduce study startup time.”

 

For another great resource on this topic, check out From Data Chaos To Clarity: How To Modernize Clinical Trial Site Selection.