The STEPS trial (an acronym for Study of Neurontin: Titrate to Efficacy, Profile of Safety) was a

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 v ...

sponsored by Parke-Davis (now

Pfizer Pfizer Inc. ( ) is an American Multinational corporation, multinational Pharmaceutical industry, pharmaceutical and biotechnology corporation headquartered at The Spiral (New York City), The Spiral in Manhattan, New York City. Founded in 184 ...

) to evaluate the

anticonvulsant Anticonvulsants (also known as antiepileptic drugs, antiseizure drugs, or anti-seizure medications (ASM)) are a diverse group of pharmacological agents used in the treatment of epileptic seizures. Anticonvulsants are also used in the treatme ...

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 A lawsuit is a proceeding by one or more parties (the plaintiff or claimant) against one or more parties (the defendant) in a civil court of law. The archaic term "suit in law" is found in only a small number of laws still in effect today. ...

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 Quality of life (QOL) is defined by the World Health Organization as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards ...

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 training for investigators, and that company sales representatives were "directly involved in collecting and recording individual subject trial data". The STEPS study has been considered as an example of

pharmaceutical marketing Pharmaceutical marketing is a branch of marketing science and practice focused on the communication, differential Positioning (marketing), positioning and commercialization of pharmaceutical products, like specialist drugs, Biotechnology in pharma ...

merging with research.

References

{{reflist Clinical trials Pfizer

Further reading

References