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Chow SC, Chang M. Adaptive design methods in clinical trials - a review. Orphanet J Rare Dis. 2008 May 2;3:11. Review. PMID: 18454853

Shein-Chung Chow of Duke University School of Medicine and Mark Chang of Millennium Pharmaceuticals have written an excellent review article about adaptive design in clinical trials, focusing on research in rare diseases, multiple myeloma and non-Hodgkin’s lymphoma.

So what is adaptive design? From the paper:

"In clinical trials, it is not uncommon to modify trial and/or statistical procedures during the conduct of clinical trials based on the review of interim data. The purpose is not only to efficiently identify clinical benefits of the test treatment under investigation, but also to increase the probability of success of clinical development. Trial procedures are referred to as the eligibility criteria, study dose, treatment duration, study endpoints, laboratory testing procedures, diagnostic procedures, criteria for evaluability, and assessment of clinical responses. Statistical procedures include randomization, study design, study objectives/hypotheses, sample size, data monitoring and interim analysis, statistical analysis plan, and/or methods for data analysis. In this article, we will refer to the adaptations (or modifications) made to the trial and/or statistical procedures as the adaptive design methods. Thus, an adaptive design is defined as a design that allows adaptations to trial and/or statistical procedures of the trial after its initiation without undermining the validity and integrity of the trial."

Adaptive design fits well with translational research, as it makes it possible to reflect real-time clinical experience in a clinical trial. Chow and Chang also present the problematic aspects of adaptive design, and in the end could help investigators employ adaptive design to optimize development of new therapies for hard-to-treat cancers and other challenging diseases.

OncologyWatch: Posts about free-access articles on aspects of oncology theory, practice and policy (about the blogger). This blog is not a source for medical advice.

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