Practical guidance for planning resources required to support publicly-funded adaptive clinical trials.

ABSTRACT: Adaptive designs are a class of methods for improving efficiency and patient benefit of clinical trials. Although their use has increased in recent years, research suggests they are not used in many situations where they have potential to bring benefit. One barrier to their more widespread use is a lack of understanding about how the choice to use an adaptive design, rather than a traditional design, affects resources (staff and non-staff) required to set-up, conduct and report a trial. The Costing Adaptive Trials project investigated this issue using quantitative and qualitative research amongst UK Clinical Trials Units. Here, we present guidance that is informed by our research, on considering the appropriate resourcing of adaptive trials. We outline a five-step process to estimate the r

SUBMITTER: Wason JMS 

PROVIDER: S-EPMC9364623 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature