Table 4.

The ADAPT-IT Adaptive Design Development Process Illustrates Procedures that Could Enhance the Development of Other Trials

Code	Description	Sample excerpt
Needs met	The ADAPT-IT process met needs and worked well with grants.	“…well-organized, thoughtful attempt at introducing a new concept to people that were unfamiliar to it.” (Progesterone Clinician) “It’s enabled me to think about how to design the clinical trial– our goal is very specific and very pragmatic.” (Progesterone Clinician)
Value of ADAPT- IT	Participants reported the value of ADAPT-IT in incorporating adaptive elements into trials.	“We had some adaptive components in our design to start with, which I loved and then we - - again, we added slightly more after we met with the adaptive team.” (SHINE Clinician) “So adaptive was the integral part of this because the concepts were there, but without the tools I think that it would have been much harder to try to accomplish these goals.” (ARCTIC Clinician)
Design/Planning	Individuals noted the design was strengthened in their grant.	“Because we don’t have any planning money so this actually served as a planning one for us in terms of design, otherwise we had a different design to begin with which had some issues with it so we could use that, especially the first meeting in July.” (ESETT Clinician)
Understand research problem	Participants described many ways the ADAPT-IT development process allowed them to understand the research problem and address research questions better.	“It has the chance to bridge the gap in dealing with heterogeneity of disease and the fact that human beings respond differently than lab animals in terms of dose, duration, and effect.” (Progesterone Clinician) “So in a way the research question went from does cooling work to is it differential as a function of time since injury.” [Referring to ICECAP] (Consultant Statistician)
Adaptive trials future	Individuals reported they were more open to adaptive trials and likely to use them again.	“I became more interested and intrigued by the idea for the adaptive design.” (ESETT Clinician) “I make more of a point of talking about adaptive design again, on the national stage and things when I am talking about SHINE.” (SHINE Clinician)
General approach to clinical trials	Participants described how the ADAPT-IT project affected their general approach to clinical trials.	“Hopefully, it will show that is does have the advantages that I’m hoping it does have and if it does I think it will change the practice of clinical trial design especially when there is competitive efficacy issues.” (ESETT Clinician) “I don’t know if it did that much to tell you the truth. I don’t know if it’s changed the way I approach trials and maybe…it’s because I also teach clinical trials so I’m always combing the literature to make sure my class is getting the most up to date information and things like that.” (NETT Statistician)
Opened opportunities	The ADAPT-IT development process opened up opportunities to explore the research question.	“I think that if we had not started long this road with the seamless design to begin with we might just have dropped the project all together, or launched a phase one study or something like that. So, yeah, it opened up our opportunities to explore the fundamental research question.” (ARCTIC Clinician)
Efficiency	Comments related to the efficiency of an adaptive approach.	“If you do a lot of clinical trials you kind of have an idea of the allocation of efforts, but when you start doing adaptive design do those efforts have to increase? Probably, but to what amount, I don’t know if anyone has a good handle on that.” (NETT Statistician) “The futile things can be identified quickly and be stopped and that we can do more efficient approaches to figure out which treatments or which doses or which timings or whatever should go forward and which ones shouldn’t” (SHINE Clinician)