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Sharing clinical trial results with the trial’s participants can build trust, show respect, and help participants feel valued. Yet most trials do not inform participants of the trial’s findings at all. Those that do inform participants rarely do so in a way that most can understand.
Researchers from the MRC Clinical Trials Unit at UCL have released a new framework of considerations for planning how to share trial results with participants. The SHOW RESPECT framework is based on qualitative findings of the Show RESPECT study, which took place within an ovarian cancer trial, but can be adapted to fit different trial contexts.
Late-phase randomised controlled trials typically require hundreds or thousands of participants to detect differences in outcomes between groups. Trial participants volunteer their time and data to help answer important research questions, often accepting a level of personal risk and/or inconvenience in the process.
Sharing results with trial participants is therefore an ethical imperative. It is also recommended by authorities, such as the UK Health Research Authority (HRA) and in the World Medical Association’s Declaration of Helsinki, which outlines principles of ethical conduct of medical research involving human subjects.
Despite this, sharing results often does not happen in practice. According to the HRA’s 2021 research transparency report, 90% of clinical trials had not told participants about their findings. Even when researchers do share results with participants, it is rarely done well. Trial teams often refer participants to academic publications, which are not written in a way that is easy for non-scientists to understand.
The Show RESPECT study tested different approaches to sharing trial results with participants. It found that participants preferred to receive a mailed printed summary of results, compared to sharing results via a webpage, with or without an email list invitation, and without the printed summary. These approaches were also feasible for site staff to implement.
Researchers surveyed and carried out semi-structured interviews with patients and site staff who were involved in Show RESPECT. By analysing themes within survey and interview answers, the team developed a framework of nine considerations for planning how to share results with participants:
- Supporting and preparing trial participants to receive results
- HOw will the results reach participants?
- Who are the trial participants?
- REsults—what do they show?
- Special considerations
- Provider—who will share results with participants?
- Expertise and resources
- Communication tools
- Timing of sharing results.
The framework is designed to be adaptable to fit different trial contexts. In the framework paper, the researchers demonstrate this by applying the framework to the CHAPAS-4 trial, which looked at treatment options for children living with HIV in Uganda, Zambia and Zimbabwe.
Other trialists can now use this framework to plan how to share results with their own trial participants.
Further information:
- The SHOW RESPECT adaptable framework in Trials
- Show Respect study page
- Testing approaches to sharing trial results with participants paper
- Site staff perspectives on sharing trial results with participants paper
- Our work on improving communication of trial results
- Sharing results of clinical trials with participants (podcast playlist)
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