General considerations about adaptive trials


Here, we highlight additional considerations that researchers should be aware of when planning and running a clinical trial using an adaptive design. These often apply to all adaptive designs although some may be more relevant to certain adaptive designs than others (see 1, 2, 3, 4, 5, 6) or in certain research context (e.g., 7). In the following, we use the terms “adaptive features” and “trial adaptations” interchangeably for changes to be made to aspects of an ongoing trial that are specified at the design stage and documented in trial documents (e.g., the protocol and statistical analysis plan) as evidence of pre-planning.


 1. Pallmann et al. Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Med. 2018;16(1):29. 
2. Wason et al. When to keep it simple – adaptive designs are not always useful. BMC Med. 2019;17(1):152.
3. Gaydos et al. Good practices for adaptive clinical trials in pharmaceutical product development. Drug Inf J. 2009;43(5):539-556.
4. Quinlan et al. Implementing adaptive designs: logistical and operational considerations. Drug Inf J. 2006;40(4):437-444.
5. He et al. Practical considerations for adaptive trial design and implementation. Springer. 2014.
6. He et al. Practical considerations and strategies for executing adaptive clinical trials. Drug Inf J . 2012;46(2):160-174.
7. Lauffenburger et al. Designing and conducting adaptive trials to evaluate interventions in health services and implementation research: practical considerations. BMJ Med. 2022;1(1):158.