What participants are told about receiving trial results when they consent to participate in a trial.

Autor: Dal-Ré R; Epidemiology Unit, Health Research Institute-Fundacion, Jimenez Diaz University Hospital, UAM, Madrid, Spain., Caplan AL; Division of Medical Ethics, School of Medicine, NYU Langone Medical Center, New York, New York, USA., Holm S; Centre for Social Ethics and Policy, Department of Law, School of Social Sciences, University of Manchester, Manchester, UK.; Centre for Medical Ethics, HELSAM, Faculty of Medicine, University of Oslo, Oslo, Norway., Sofat R; Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.; BHF Data Science Centre, Health Data Research, London, UK., Stephens R; Cancer Research Advocates Forum (CRAF-UK), Stevenage, UK.
Jazyk: angličtina
Zdroj: Basic & clinical pharmacology & toxicology [Basic Clin Pharmacol Toxicol] 2025 Jan; Vol. 136 (1), pp. e14115.
DOI: 10.1111/bcpt.14115
Abstrakt: 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.
(© 2024 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society). Published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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