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Compensating patients in trials: Perspectives from an ethical committee versus sponsor
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International audience.
Background:
According to European clinical research legislation, no undue influence,including financial incentives, should be used to encourage participationin clinical trials. Financial compensation should be based on the inconvenienceexperienced by patients and is determined by the sponsor.
Objectives:
The objective of this study was to assess the adequacy of patients'financial compensation by obtaining an external ethical opinion compared to theactual compensation provided.
Methods:
We randomly selected and reviewed 50 clinical drug trials, including25 academic and 25 industry-sponsoredstudies. An external ethics group consistingof three members from French ethics committees, blinded to the actualcompensation and the sponsor, retrospectively reviewed the study characteristicsand assessed whether financial compensation was appropriate. Cohen's Kappatest measured agreement between actual compensation and the ethics group'sopinion, and the McNemar test measured discrepancies.
Results:
There was no agreement between the actual financial compensationand the ethics group's opinion (K = −.07; 95% CI = [−.16–.02]). More discrepancieswere found in favour of financial compensation according to the ethics groupthan provided by sponsors (12 vs. 2, p = .016). The ethics group recommendedfinancial compensation in 12 out of 50 studies (24%), which were studies with ahigher number of additional visits (p = .004) and were more frequently sponsoredby industry (p = .008). Sponsors only provided financial compensation in 2 out of50 studies (4%).
Conclusion:
Patients are rarely compensated despite the perceived inconvenience.Both sponsors and ethics members struggle to determine the need for financialcompensation, indicating a need for more precise recommendations forboth parties.
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