Jp. Boissel et Mc. Haugh, CLINICAL-TRIAL REGISTRIES AND ETHICS REVIEW BOARDS - THE RESULTS OF ASURVEY BY THE FICHTRE PROJECT, Fundamental and clinical pharmacology, 11(3), 1997, pp. 281-284
Clinical trial registries could make an important contribution to rese
arch by playing a role in the avoidance of trial duplication as well a
s serving as a source of information on the existence of clinical tria
ls for those wishing to perform overviews. In order to fulfil their ro
le efficiently, these registries should contain information about all
trials. However, resources of existing registries are not exhaustive.
Currently, all protocols for clinical trials must be submitted to an e
thics review board for approval - thus these boards could provide an i
nvaluable source of information about what trials are being performed.
One of the objectives of our project was to assess the attitudes of t
he ethics review boards (ERBs) to providing this type of information t
o clinical trial registries. We received 115 replies from 281 question
naires sent to ERBs in seven European countries. More than 70% replied
that they would be willing to communicate information about the trial
s they review, and there seemed to be general agreement that clinical
trial registries should be funded and supported by governments. Althou
gh ERBs could provide a useful source of information, only an official
body such as the Ministry of Health or a drug regulatory body could e
stablish and run a clinical trials registry efficiently.