Adaptive clinical trials in public health emergency contexts: ethics considerations
Open Access
- 23 March 2023
- journal article
- Published by F1000 Research Ltd in Wellcome Open Research
Abstract
While Adaptive Clinical Trials (ACTs) have grown in prevalence, prominence, and impact, the ethical issues implicit in such trial designs, particularly in the context of public health emergencies, have been afforded relatively scant attention. This work argues that the ethical dimensions of ACTs should be considered at trial conception, factored into the trial’s design, and subject to ongoing evaluation during the trial’s conduct.Funding Information
- Wellcome (214711)
This publication has 30 references indexed in Scilit:
- Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysisBMC Medical Ethics, 2015
- The Platform TrialJAMA, 2015
- Are outcome-adaptive allocation trials ethical?Clinical Trials, 2015
- Ethical Considerations for Outcome‐adaptive Trial Designs: A Clinical Researcher's PerspectiveBioethics, 2014
- A tutorial on pilot studies: the what, why and howBMC Medical Research Methodology, 2010
- Adaptive design clinical trials: Methodology, challenges and prospectIndian Journal of Pharmacology, 2010
- Assessing the Impact of Protocol Design Changes on Clinical Trial PerformanceClinical Journal of Sport Medicine, 2008
- Adaptive design methods in clinical trials – a reviewOrphanet Journal of Rare Diseases, 2008
- LABORATORY AND CLINICAL TRIALS OF PATULINThe Lancet, 1944
- PATULIN IN THE COMMON COLDThe Lancet, 1943