Dal-Ré Rafael, Caplan Arthur L, Holm Søren, Sofat Reecha, Stephens Richard
Epidemiology Unit, Health Research Institute-Fundacion, Jimenez Diaz University Hospital, UAM, Madrid, Spain.
Division of Medical Ethics, School of Medicine, NYU Langone Medical Center, New York, New York, USA.
Basic Clin Pharmacol Toxicol. 2025 Jan;136(1):e14115. doi: 10.1111/bcpt.14115.
In a 2022 consultation, the UK public highlighted the need to disseminate trial results to participants. We assess whether the information provided to trial participants in publicly available participant information sheets (PISs) of trials conducted in the UK is helpful for future trials. This cross-sectional study is based on a search conducted on 18 August 2023 on ClinicalTrials.gov looking for UK completed or terminated phase 2-4 medicine trials. The posted PIS (or the protocol, if the PIS was unavailable) were reviewed checking the text used to inform participants on how results will be disseminated to participants. Of the 48 records retrieved, 32 were included: 23 and 9 had the PIS or the protocol posted, respectively. Seven (22%) did not mention dissemination of results to participants. Thirteen (41%) used the same short "common, standard text" of four sentences to inform participants. This text mentioned ClinicalTrials.gov as the source for further information and US Law as the reason for it. Twelve (38%) used different texts with different scopes and lengths. These results showed that publicly available PISs of medicinal product trials conducted in the UK are very limited and of scarce utility for investigators aiming to start a new trial.
在2022年的一次咨询中,英国公众强调了向试验参与者传播试验结果的必要性。我们评估了在英国进行的试验的公开可用参与者信息表(PIS)中提供给试验参与者的信息对未来试验是否有帮助。这项横断面研究基于2023年8月18日在ClinicalTrials.gov上进行的一次搜索,以查找英国已完成或终止的2-4期药物试验。对发布的PIS(如果没有PIS,则审查试验方案)进行了审查,检查用于告知参与者结果将如何传达给他们的文本。在检索到的48条记录中,纳入了32条:分别有23条和9条发布了PIS或试验方案。其中7条(22%)未提及向参与者传播结果。13条(41%)使用了相同的由四句话组成的简短“通用标准文本”来告知参与者。这段文本提到ClinicalTrials.gov是获取更多信息的来源以及美国法律是这样做的原因。12条(38%)使用了范围和长度不同的不同文本。这些结果表明,英国进行的药品试验的公开可用PIS非常有限,对于旨在开展新试验的研究人员来说实用性很差。