PMID: 8939118Nov 16, 1996Paper

Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners

BMJ : British Medical Journal
P Wise, M Drury

Abstract

To assess the outcome of 100 general practice based, multicentre research projects submitted to the ethics committee of the Royal College of General Practitioners by pharmaceutical companies or their agents between 1984 and 1989. Analysis of consecutive submitted protocols for stated objectives, study design, and outcomes; detailed review of committee minutes and correspondence in relation to amendment and approval; assessment of final reports submitted at conclusion of studies. 82 finally approved protocols, embracing 34,523 proposed trial subjects and 1195 proposed general practice investigators. Success at enrolling subjects and investigators; commencement and completion data; validity of final report's assessment of efficacy, safety, tolerability, and acceptability; and method of use and dissemination of findings. 18 studies were not approved and 45 had to be amended. Randomised controlled trials comprised 46 of the original submissions. Remuneration considerations, inadequate information or consent sheets, pregnancy safety, the need to discontinue existing therapy, and suboptimal scientific content were major reasons for rejecting studies or asking for amendments. Of the 82 approved studies 8 were not started. Shortfalls o...Continue Reading

References

May 20, 1995·BMJ : British Medical Journal·J Pearn

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Citations

Feb 14, 2002·Trends in Biotechnology·Lara Marks, Emmett Power
Dec 11, 2003·The American Psychologist·David O AntonuccioTerry Michael McClanahan
Jan 11, 2013·BMJ : British Medical Journal·An-Wen ChanDavid Moher
Jun 4, 2013·Trials·Anja Maria BrændJørund Straand
Feb 13, 2002·Sports Medicine·Roy J Shephard
Feb 20, 2002·Controlled Clinical Trials·Masahiro Takeuchi
May 6, 2008·International Journal for Equity in Health·Marin C GemmillElias Mossialos
May 6, 2016·BMC Medical Research Methodology·Stéphane CullatiThomas V Perneger
Sep 4, 2015·Journal of Empirical Research on Human Research Ethics : JERHRE·Elina HemminkiElena Regushevskaya
Mar 11, 2020·The British Journal of General Practice : the Journal of the Royal College of General Practitioners·Jane WilcockDavid Spitzer
Nov 22, 2017·The British Journal of General Practice : the Journal of the Royal College of General Practitioners·Elizabeth MorrisGail Hayward
Feb 24, 2018·The British Journal of General Practice : the Journal of the Royal College of General Practitioners·John Holden
Mar 14, 2018·The British Journal of General Practice : the Journal of the Royal College of General Practitioners·Tom MarghamSally A Hull
Nov 18, 2018·Therapeutic Innovation & Regulatory Science·Bolennart Eriksson
Aug 2, 2001·The Medical Journal of Australia·C A Commens

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