A Hercule Poirot of clinical research
2015; Springer Science+Business Media; Volume: 19; Issue: 1 Linguagem: Inglês
10.1007/s10120-015-0555-3
ISSN1436-3305
Autores Tópico(s)Health and Medical Research Impacts
ResumochemotherapyHercule Poirot: ''I gave to you the clues and every chance to discover the truth…'' Agatha Christie, Curtain: Poirot's Last Case (1975) Well-conducted randomized clinical trials have now become mandatory to confirm the effects of new therapies and to obtain marketing approval from the healthcare authorities.Even after registration and filing, post-marketing, investigator-driven clinical trials are often conducted to provide repeated confirmation of a new drug's efficacy and safety.Although stringent regulations have long been imposed on registration trials, rules for the conduct of post-marketing trials have not been standardized, and the lack of oversight of these studies has occasionally led to investigator misconduct.In Japan, for instance, a major case of data fabrication was recently disclosed by a whistleblower in an investigator-driven clinical trial for an antihypertensive blockbuster drug.This case is by no means isolated [1].More rigorous, transparent, and well-conducted post-marketing clinical trials are needed, as mandated by the new ethical guideline enacted
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