How to ascertain drug related deaths during clinical trials ?
Recent guidelines by the Drug Controller General of India require extra care by Investigators & Sponsors of Clinical Trials in India. The author, an eminent member & Chairman of various Independent Ethics Committees in Mumbai, proposes various concrete solutions for adherence to these guidelines. Insurance cover to the subjects, use of Internet databanks for drug interactions, active involvement by the pharmacologists in Ethics Committee, review of data from animal studies, being amongst them. In case of death due to trial, autopsies, or at least verbal autopsies, are essential in the interest of Science and Law. More importantly Anticipation and prevention of ADEs can be done by exclusion of subjects from trials by using newer technologies like cDNA in microarrays to determine several polygenic quantitative trait loci (QTLs) and tests for Single Nucleotide Polymorphisms (SNPs). Drug manufacturers must provide prototypes of Affymetrix chips to clinicians and bear the cost in their own enlightened self-interest.
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D016907:Adverse Drug Reaction Reporting Systems / Q000941:ethics / Q000331:legislation & jurisprudence; D000818:Animals; D001344:Autopsy; D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D016903:Drug Monitoring; D015507:Drugs, Investigational / Q000009:adverse effects*; D017041:Ethics Committees / Q000941:ethics / Q000331:legislation & jurisprudence; D033161:Government Regulation; D019983:Guideline Adherence; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D007194:India
D015507:Drugs, Investigational