Return of participant-level clinical trial results to participants: pilot of a simplified centralised approach.

ABSTRACT:

Objectives

Public access databases such as clinicaltrials.gov achieve dissemination of clinical trial design and aggregated study results. However, return of participant-level data is rarely done. A key barrier includes the proprietary ownership of data by the sponsor. Additionally, investigators may not have access to centralised data, and per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice, must maintain the confidentiality of participants. This study piloted an approach to return both individual and aggregate clinical trial data to parents of children participating in a series of open-label clinical trials.

Setting and design

A small biotech company obtained central ethics approval (centralis

SUBMITTER: Hoffman E 

PROVIDER: S-EPMC10961551 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature