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.[1] 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.[2][3][4]

Detailed documents were released due to litigation against Parke-Davis and reviewed by several researchers in a 2011 Annals of Internal Medicine article.[2] 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.[2] 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".[2]

The STEPS study has been considered as an example of pharmaceutical marketing merging with research.[5]

Further reading
  • Morrell, MJ (1999). "Dosing to efficacy with neurontin: the STEPS trial. Study of Titration to Effect Profile of Safety". Epilepsia. 40 Suppl 6: S23–6, discussion S73–4. doi:10.1111/j.1528-1157.1999.tb00929.x. PMID 10530679.
  • Beran, R; Berkovic, S; Black, A; Danta, G; Dunne, J; Frasca, J; Grainger, K; Kilpatrick, C; McKenzie, R; McLaughlin, D; Schapel, G; Somerville, E (October 2001). "AUStralian study of titration to effect profile of safety (AUS-STEPS): high-dose gabapentin (neurontin) in partial seizures". Epilepsia. 42 (10): 1335–9. doi:10.1046/j.1528-1157.2001.23000.x. PMID 11737169.

References
  1. Morrell MJ, McLean MJ, Willmore LJ, Privitera MD, Faught RE, Holmes GL, Magnus L, Bernstein P, Rose-Legatt (June 2000). "Efficacy of gabapentin as adjunctive therapy in a large, multicenter study. The Steps Study Group". Seizure. 9 (4): 241–8. doi:10.1053/seiz.2000.0407. PMID 10880282.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  2. Krumholz, Samuel D.; Egilman, David S.; Ross, Joseph S. (2011). "Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) TrialA Narrative Account of a Gabapentin Seeding Trial". Archives of Internal Medicine. 171 (12). doi:10.1001/archinternmed.2011.241. ISSN 0003-9926. PMC 3319750. PMID 21709111.
  3. Alexander, G. Caleb (2011). "Seeding Trials and the Subordination of Science". Archives of Internal Medicine. 171 (12): 1107–8. doi:10.1001/archinternmed.2011.232. ISSN 0003-9926. PMID 21709112.
  4. Malakoff, D. (2008). "Allegations of Waste: The 'Seeding' Study". Science. 322 (5899): 213. doi:10.1126/science.322.5899.213. ISSN 0036-8075. PMID 18845743.
  5. Steinman, Michael A. (2006). "Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents". Annals of Internal Medicine. 145 (4): 284–93. doi:10.7326/0003-4819-145-4-200608150-00008. ISSN 0003-4819. PMID 16908919.
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