Any challenges, risks of biases, and whether this trial design can be used for investigating lasting effects of a treatment (upon switching to placebo - i.e. Stopping treatment).
Please let me know if the following references/sites are useful to you:
1. Enriched enrolment: definition and effects of enrichment and dose in ...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2492925/May 16, 2008 ...
Enriched enrolment study designs have been suggested to be useful for proof of concept when only a proportion of the diseased population ...
2. A comparison between enriched and nonenriched enrollment ...
https://www.ncbi.nlm.nih.gov/pubmed/19851161Clin J Pain. 2009 Nov-Dec;25(9):797-807. doi: 10.1097/AJP.0b013e3181b12dec . Enriched enrollment randomized withdrawal trial designs of analgesics: focus ...
3, A comparison between enriched and nonenriched enrollment
..
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3206784/
An enriched enrollment randomized withdrawal (EERW) study is a type of randomized, controlled trial in which potential participants are assigned to receive the ...
4. Enrichment Strategies for Clinical Trials to Support Approval of - FDA
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm332181.pdfENRICHMENT
STUDY DESIGN AND OTHER CONSIDERATIONS . .... 36 these selection strategies are obvious (e.g., patients are enrolled only if they have the ...
Dennis
Dennis Mazur
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