Rethinking statistical approaches to evaluating drug safety
Resource
Yonsei Medical Journal 48 (6): 895-900
Journal
Yonsei Medical Journal
Journal Volume
48
Journal Issue
6
Pages
895-900
Date Issued
2007
Author(s)
Abstract
Purpose: The current methods used to evaluate the efficacy of drug products are inadequate. We propose a non-inferiority approach to prove the safety of drugs. Materials and Methods: Traditional hypotheses for the evaluation of the safety of drugs are based on proof of hazard, which have proven to be inadequate. Therefore, based on the concept of proof of safety, the non-inferiority hypothesis is employed to prove that the risk of new drugs does not exceed a pre-specified allowable safety margin, hence proving that a drug has no excessive risk. The results from papers published on Vioxx? and Avandia? are used to illustrate the difference between the traditional approach for proof of hazard and the non-inferiority approach for proof of safety. Results: The p-values from traditional hypotheses were greater than 0.05, and failed to demonstrate that Vioxx? and Avandia? are of cardiovascular hazard. However these results cannot prove that both Vioxx? and Avandia? are of no cardiovascular risk. On the other hand, the non-inferiority approach can prove that they are of excessive cardiovascular risk. Conclusion: The non-inferiority approach is appropriate to prove the safety of drugs.
Subjects
Effectiveness; No excessive risk; Non-inferiority approach; Safety
SDGs
Other Subjects
celecoxib; ibuprofen; naproxen; nonsteroid antiinflammatory agent; rofecoxib; rosiglitazone; cardiovascular risk; clinical trial; colorectal adenoma; congestive heart failure; drug efficacy; drug industry; drug safety; hazard ratio; heart infarction; human; mortality; review; risk; risk assessment; statistical analysis; thrombosis; Biometry; Confidence Intervals; Controlled Clinical Trials as Topic; Data Interpretation, Statistical; Drug Evaluation; Drug Toxicity; Humans; Models, Statistical; Research Design
Type
journal article
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