Table 5.

The implications for educating the broader research community

Code		Description	Sample excerpt
Difficult to articulate		Participants noted it is difficult to "articulate what adaptive design represents.”	“Too many people out there, including our study section don’t really understand adaptive design.” (SHINE Clinician) “I’m going to struggle with a twelve-page limit to a protocol that is reviewed by the NIH that can only have maybe two or three pages about the design…need to be able to explain a number of things including the Adaptive Design, and which we do less than a page, maybe half a page to describe the Adaptive Design.” (Progesterone Clinician)
Are review committees ready?		Participants wondered whether review committees at NIH are ready for adaptive designs.	“I do worry that review committees at the NIH are still not ready for this.” (Progesterone Clinician) [Regarding ICECAP] “It’s hard to know from what we’ve heard of the reviews so far, but I actually think that despite it being less fundamentally different I still think that review didn’t get it.” (ADAPT-IT Clinician)
Challenges in applying adaptive		Participants reported it was important to acknowledge and dialogue about the challenges of applying adaptive methodology appropriately.	“I think it’s an option for some disease areas, some more so than others but I’m not quite sure I’m on board yet.” (NETT Statistician) “The advantage of the traditional design is when there are more questions to be answered and something has to be changed rudimentarily, the control group or the site, that isn’t answered by the adaptive process.” (NIH Representative) “There are benefits to adaptive design but I think there are some drawbacks, and let’s discuss those drawbacks rather than just push through based on only the good things” (NETT Statistician 2)
Practical implementation		Participants discussed the need for information about practical day-to-day aspect of operating an adaptive trial.	“There’s some complexity in the implementation of this type of trial at the local level because of the varying doses, durations, and the way the Adaptive Design requires – it will change and how that affects the clinicians who are enrolling patients, the coordinators, and the pharmacy at the local level.” (NIH Representative) “Often the modification sounded efficient but in reality it would take longer and more money” (Progesterone Clinician)
Ongoing training resources needed	Additional training resources are needed to understand adaptive designs and the use of Bayesian techniques in clinical trial design.		“In terms of the goal of getting all of the parties and the stakeholders in the same room and hearing one another speak about it, that part was great. As far as addressing adaptive design, I don’t know if that would totally meet the adaptive project and maybe that wasn’t the primary goal of the adaptive project..” (NETT Statistician) “…says well the model learns from it, but I’m not quite sure how that happens, so that’s the part that’s still a little mystery to me..” (NETT Statistician) “There are lots of places you can send you trainees to get a semester of medical epidemiology but there is no place to send them to get a semester of introduction to adaptive design in clinical trials.” (SHINE Clinician)