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

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.

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Publication Details

Journal
Basic & Clinical Pharmacology & Toxicology
Published
2024-12-19
DOI
https://doi.org/10.1111/bcpt.14115
Primary Topic
Ethics in Clinical Research
Type
article
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article

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

Richard Stephens, Rafael Dal‐Ré, Reecha Sofat, Arthur L. Caplan et al.
Basic & Clinical Pharmacology & Toxicology
Ethics in Clinical Research
article

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

Richard Stephens, Rafael Dal‐Ré, Reecha Sofat, Arthur L. Caplan, Søren Holm
article en

Abstract

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.

Basic & Clinical Pharmacology & ToxicologyVol. 136(1)
University of Liverpool (GB), University of Oslo (NO), University of Manchester (GB), NYU Langone Health (US), Hospital Universitario Fundación Jiménez Díaz (ES), Health Data Research UK (GB), Universidad Autónoma de Madrid (ES)
Peace, Justice and strong institutions
Openalex Percentile: Top 64%
Ethics in Clinical Research
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