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STEPS Trial
The STEPS trial (an acronym for Study of Neurontin: Titrate to Efficacy, Profile of Safety) was a clinical trial sponsored by Parke-Davis (now Pfizer) to evaluate the anticonvulsant Neurontin. It is notable for being a seeding trial to promote that drug and for contributing to the drug companies loss in the court case '' Franklin v. Parke-Davis''. Detailed documents were released due to litigation against Parke-Davis and reviewed by several researchers in a 2011 ''Annals of Internal Medicine'' article. The STEPS trial was presented as a phase IV clinical trial with the stated objective to "study efficacy, safety, tolerability, and quality of life among gabapentin users"; however, the trial was actually completely uncontrolled and unblinded and the scientific validity of the trial was considered dubious by independent external sources. Documents also revealed that the trial recruited 772 physician investigators, many with very limited research experience, provided inadequate tr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received institutional review board, health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small Pilot experiment, pi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
