Pharmacovigilant, Responsable de lunite de vigilance des essais cliniques (UVEC), Direction de la Recherche et de l'innovation, CHU Caen Normandie, Caen, France.
CHU Grenoble Alpes, La Tronche, France.
Eur J Clin Invest. 2023 Oct;53(10):e14044. doi: 10.1111/eci.14044. Epub 2023 Jun 21.
According to European clinical research legislation, no undue influence, including financial incentives, should be used to encourage participation in clinical trials. Financial compensation should be based on the inconvenience experienced by patients and is determined by the sponsor.
The objective of this study was to assess the adequacy of patients' financial compensation by obtaining an external ethical opinion compared to the actual compensation provided.
We randomly selected and reviewed 50 clinical drug trials, including 25 academic and 25 industry-sponsored studies. An external ethics group consisting of three members from French ethics committees, blinded to the actual compensation and the sponsor, retrospectively reviewed the study characteristics and assessed whether financial compensation was appropriate. Cohen's Kappa test measured agreement between actual compensation and the ethics group's opinion, and the McNemar test measured discrepancies.
There was no agreement between the actual financial compensation and the ethics group's opinion (K = -.07; 95% CI = [-.16-.02]). More discrepancies were found in favour of financial compensation according to the ethics group than provided by sponsors (12 vs. 2, p = .016). The ethics group recommended financial compensation in 12 out of 50 studies (24%), which were studies with a higher number of additional visits (p = .004) and were more frequently sponsored by industry (p = .008). Sponsors only provided financial compensation in 2 out of 50 studies (4%).
Patients are rarely compensated despite the perceived inconvenience. Both sponsors and ethics members struggle to determine the need for financial compensation, indicating a need for more precise recommendations for both parties.
根据欧洲临床研究法规，不应使用任何不当影响，包括经济激励，来鼓励参与临床试验。经济补偿应基于患者所经历的不便，并由赞助商确定。
本研究旨在通过获得外部伦理意见来评估患者经济补偿的充分性，与实际提供的补偿进行比较。
我们随机选择并审查了 50 项临床药物试验，包括 25 项学术研究和 25 项行业赞助研究。一个由三名法国伦理委员会成员组成的外部伦理小组对研究特征进行回顾，并评估经济补偿是否适当，该小组对实际补偿和赞助商均不知情。采用 Cohen's Kappa 检验评估实际补偿与伦理小组意见之间的一致性，采用 McNemar 检验评估差异。
实际经济补偿与伦理小组意见之间无一致性（K=-.07；95%CI=[-.16-.02]）。根据伦理小组的意见，发现更多赞成经济补偿的差异，而不是赞助商提供的补偿（12 比 2，p=0.016）。伦理小组建议在 50 项研究中的 12 项（24%）中提供经济补偿，这些研究有更多的额外访视（p=0.004），且更多由行业赞助（p=0.008）。赞助商仅在 50 项研究中的 2 项（4%）中提供经济补偿。
尽管存在不便感知，但患者很少得到补偿。赞助商和伦理成员都难以确定经济补偿的必要性，这表明双方都需要更精确的建议。
