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


METHODS
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.


METHODS
82 finally approved protocols, embracing 34,523 proposed trial subjects and 1195 proposed general practice investigators.


METHODS
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.


RESULTS
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 of investigators (of 39%) and trial subjects (of 37%) and an overall 23% withdrawal rate were responsible for a significant incidence of inconclusive results. Within the six year follow up interval, only 19 of the studies had been formally published.


CONCLUSIONS
This audit identified substantial ethical concerns in the process of approving multicentre general practice pharmaceutical research.
Wise
P
P
Royal College of General Practitioners, London.
Drury
M
M
D002985:Clinical Protocols; D032962:Consent Forms; D004358:Drug Therapy; D026724:Ethical Review; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D005194:Family Practice; D006801:Humans; D033181:Information Dissemination; D008485:Medical Audit; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D035842:Research Subjects; D036302:Therapeutic Human Experimentation