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Large phase 3 trials often continue for years after interim data show the drug is unlikely to work. Pre-registering futility boundaries at 30 to 50 percent of the information, judged by independent committees and reported publicly, would stop them earlier, sparing patients and freeing money for better ideas.
Phase 3 protocols include non-binding but pre-registered futility boundaries at 30-50 percent information (predictive probability of success below a threshold), evaluated by independent monitoring committees, with public reporting of the interim decision. Sponsors commit to the rule in the registry entry, reducing the temptation to continue for commercial reasons.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Failures are hidden, Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Failures are hidden, Trial design, endpoints and cost.
Shares ClinicalTrials.gov, Failures are hidden, Trial design, endpoints and cost.
Shares ClinicalTrials.gov, Failures are hidden, Funding follows fashion, not burden.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Funding follows fashion, not burden, Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Trial design, endpoints and cost.