Academic journal article Bulletin of the World Health Organization

Registering Clinical Trials Is Necessary for Ethical, Scientific and Economic Reasons

Academic journal article Bulletin of the World Health Organization

Registering Clinical Trials Is Necessary for Ethical, Scientific and Economic Reasons

Article excerpt

For unbiased judgement of the effectiveness of medications or non-pharmaceutical therapies, controlled clinical trials are the most important elements in deciding whether an intervention does more good than harm. Often undervalued, but increasingly used under the concept of evidence-based medicine, trial results are of utmost importance as the basis of decision-making in health care. As controlled trials are one of the main sources of medical knowledge, it is essential that results of completed trials and information about ongoing ones are available to all those professionally involved in health research and health care as well as to patients.

Public access to trial information is essential from various perspectives. First of all, research is a cumulative process, the unbiased synthesis of which is particularly important in order to summarize existing knowledge about a specific problem. Systematic reviews need to have complete information about ongoing and completed trials: the widespread phenomenon of not publishing trials with negative or disappointing results can seriously distort perceptions of the effectiveness of medical interventions (1). Knowledge of unreported trials may help to reduce the detrimental effects of this publication bias.

Next, reliable information about trials is necessary to identify evidence gaps and thus indicate where further trials are needed. Planning of new trials has to be based on knowledge gained from previous ones, and information about similar trials is necessary to avoid duplication of effort and to ensure optimal use of resources. Prioritization of research programmes is dependent on complete knowledge of the evidence from trials.

Finally, it is particularly important for patients and doctors to be able to obtain support to find trials suitable for participation. Patients and consumers of health care need access to information about trial results to allow them to make an informed choice. Participants in clinical trials expect the results to be made fully available to future patients; this is stipulated in the contract when they agree to participate in a trial, with its associated risks of not receiving the optimal treatment or experiencing adverse events. Underreporting of trial results is thus unacceptable from an ethical point of view and should be overcome by publicly accessible registers (2).

In view of these convincing arguments which have been put forward for more than 30 years (3, 4), it is surprising that no system has yet been developed that allows systematic access to information about past or current clinical trials. Various local as well as publicly accessible registers have been set up over the past decade. For example, the United States National Institutes of Health, through the National Library of Medicine (5) and the National Cancer Institute, have developed publicly available web sites that facilitate searching for clinical trials (6, 7). In Europe, the European Science Foundation published a policy briefing that strongly recommends registration of controlled trials (8, 9) and urged its members to introduce registration. However, all these registers are of limited use as they cover only specific geographical regions or medical specialties and are not mandatory. …

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