A few weeks ago, I had the pleasure of interviewing Beth Harper. Beth has extensive experience in the field of clinical research. Among some of her prestigious past positions; she was an associate director at Merck and was Sr. Vice President at D. Anderson & Company. She is currently an adjunct professor at George Washington University, CCO (Chief Clinical Officer) of Centerphase Solutions, a clinical research focused company dedicated to streamlining the clinical trials process and one of TrialX’s esteemed advisers. You can read more about her impressive biography on her LinkedIn page.
I asked Beth a range of questions and got such great information from her that I needed to break this interview into 3 parts. The first section will focus on obstacles to conducting good quality clinical research and the second and third section will be dedicated to patient recruitment.
We spoke for about an hour, and with Beth’s birds eye view answering my questions fueled by my own frustrations and observations from my decade or so working in the field, I believe we have come up with answers to some very relevant issues within the clinical research field today.
I hope you enjoy this 3 part interview series:
What are the three biggest road blocks or the three things we can to do more of in the clinical research field to positively impact the quality and efficiency of clinical research ?
Great question Kimberly;
1) I think that everything starts from the protocol. We need better designed, more executable and patient friendly protocols. Protocols are getting more complex and increasingly difficult to recruit for the targeted patient population. Protocols are often developed in isolation of the, on-the–ground medical practice and the increasing complexity inhibits us from rapidly moving forward, if at all in some cases. So first let’s start with overhauling the protocol design process to increase executability.
2) We need to improve sponsor and site relationship. We’ve operated in a sort of antagonistic, “us vs. them” mentality, but we need each other to survive. We need to view the other as a collaborator in this enterprise. I think, in particular, a lot of work needs to be done to better understand the complexities of what goes into developing the budget which is a chronic source of delay in getting a study activated at a given site.
3) The piece I am most passionate about is, feasibility. We need more accurate feasibility studies of a protocol with much more up front effort ensuring workability, ensuring that the patients exist, that budgets are realistic and that there are realistic time lines that accommodate the realities that we uncover during the feasibility process.
I worked on all aspects of clinical trials and from the day we signed the CDA, it sometimes took a year for the clinical trial to be active, open and accruing so I know exactly what she is talking about. One other thing I mentioned to Beth is something that always used to aggravate me and my team. Entire sections of pharmaceutical sponsored protocols and some CRFs seemed to be copy/paste jobs from the previous protocol. This would create delays, confusion and needless tests to be performed and so I asked her:
I observed a lot of inefficiency and with so much regulatory burden and so much pressure from the FDA for both sides, there was so much information and data we needed to record, but how much of it is actually important?
Exactly, really getting clarity on the design, pulling out the most important questions the study is designed to answer, only getting the data that is relevant and paying attention to document development are all key. These oversights create untold amendments and expenses on the data collection side that we really didn’t need to collect in the first place, not to mention the risks and burden this places on the patients to do all the things that they really didn’t need to do.
I was so glad this was coming out because I really want to highlight relevant issues inhibiting the advancement of clinical trials.
Do most industry sponsored clinical trials meet their initial accrual goals – why or why not?
Ultimately we get the patients but it’s a matter of time. So when you ask, did we meet the initial goals meaning the planed number of patients in the planned for amount of time within a planned for budget? As long as I have been working in the industry, the answer is NO.
Why is that? It goes back to our root causes we talked about. It’s an un-executable protocol that has not been vetted. Sites routinely over-estimate their enrollment potential because they are enthusiastic about the trial and want to get selected to participate. We don’t do the proper feasibility, we don’t do recruitment planning and we don’t budget for what it’s really going to take to find patients. What often happens is that we get the wrong sites who either don’t have the patients or need to go through very extensive outreach and awareness building efforts just to reach patients. This then can lead down another rabbit hole which is that patients are misinformed so even if we have the right sites but are relying on a population who doesn’t understand what clinical research is let alone the nuances and details around this particular trial then there is a disconnect. We have to have an educated audience who is aware of the trial, we need to have the proper site to be able to enroll them and we need that study that is enrollable.
Beth and I then spoke mainly about clinical trials recruitment, a very important issue and one that urgently needs to be improved in order for clinical research to grow and to be relevant, but I’ll save this for another blog.
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