Differing attitudes of industry and academia towards controlled clinical trials

Abstract

A consensus conference was held in 1984 on controversial issues concerning controlled clinical trials. Thirty-six individuals working in academic institutions, forty-six in industry and twelve in regulatory authorities participated. Academics accepted and industrial representatives rejected the following: existing regulations cannot cope with the rate at which new treatments develop; drug companies may be reluctant to undertake surveillance programmes because sales will fall if adverse reactions are detected; novel remedies should not be promoted before extensive post-marketing surveillance; third parties should finance trials promising to reduce the costs of illness and trialists should be separated from sponsors in data analysis and interpretation, the investigator owning the data unless stated otherwise. Industrial representatives supported and academics rejected the following: government price control inhibits drug development and a multicentre trial can be justified simply by the wish to speed drug registration.

Powered toothbrushes: a review of clinical trials

“…It is now recognised that bias originating from material gain by sponsors, manufacturers and trialists can affect the outcome of clinical trials (Blum et al 1986) although the use of multiple trial centres and independent auditors are likely to expose both outliers and irregularities. It is evident from the data in Tables 1 and 2 that in the majority of cases, the PTBs evaluated in clinical trials are marketed products rather than prototypes.…”

“…Analysis issues of wider significance and which pertain to all industry sponsored clinical trials are also relevant to PTB studies. There is some agreement between industry and academics/clini-cians that sponsors and trialists should be separated in the process of data analysis in order to further reduce the effects of bias and self-interest (Blum et al 1986). It is important that a study protocol clearly defines not only the proposed methods for statistical analysis but also all aspects of intellectual property including ownership of the data, who is the responsible party for analysis, and who will undertake the preparation of the final report and any subsequent submission for publication.…”