14.Randomization01.Adaptive enrichment design - sporedata/researchdesigneR GitHub Wiki
- These are trials where the eligibility criteria can be adaptively updated during the trial, progressively restricting the inclusion to patients who are more likely to benefit from the intervention [1].
- Patients willing to be randomized
- Guidelines for the Content of Statistical Analysis Plans in Clinical Trials [2].
- Books
* - Articles
- Treatment effects in multicenter randomized clinical trials [3].
- Common references for randomized designs.
[1] Simon N and Simon R. Adaptive enrichment designs for clinical trials. Biostatistics. 2013 Sep;14(4):613-625.
[2] Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, and others. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. Jama. 2017 Dec 19;318(23):2337-2343.
[3] Senn SJ, Lewis RJ. Treatment effects in multicenter randomized clinical trials. Jama. 2019 Mar 26;321(12):1211-2.