PubMed · 7908352
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J J Lipsky. 1994-04-09. Concorde lands.. https://doi.org/10.1016/s0140-6736(94)90002-7
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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. DESIGN: 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. SUBJECTS: 82 finally approved protocols, embracing 34,523 proposed trial subjects and 1195 proposed general practice investigators. MAIN OUTCOME MEASURES: 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.
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OBJECTIVE: To compare the costs of diagnosis and treatment of patients clinically suspected of pulmonary embolism, before and after the adoption of the Dutch consensus for the diagnosis of pulmonary embolism. DESIGN: Study of the records, followed by a prospective study with a follow-up lasting 6 months. SETTING: Academic Medical Centre and Slotervaart Hospital, Amsterdam, the Netherlands. METHOD: Data were collected on 120 patients from the preconsensus period and on 452 patients examined according to the consensus strategy. This established the average patterns of medical consumption of patients before and after adoption of consensus. The mean costs per patient were then estimated. RESULTS: Diagnosis and treatment of a patient according to the consensus strategy on the basis of our estimates were considerably less expensive than non-protocolled diagnosis and treatment (Dfl. 4,413 as against Dfl. 5,115 per patient). This difference mainly resulted from shorter hospital stays owing to more rapid completion of the diagnosis. Considering the large number of annual hospital admissions in the Netherlands in connection with this diagnosis, savings of up to Dfl. 26 million would appear possible if the consensus were followed nationwide. CONCLUSION: Considerable amounts are involved in the diagnosis and treatment of pulmonary embolism in the Netherlands. Accordingly, further research into possibilities to make these more efficient would appear advisable.