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#TalkClinicalTrials: Sharing trial results with trial participants: where are we at and how do we move forwards?

#TalkClinicalTrials: Sharing trial results with trial participants: where are we at and how do we move forwards?

The following blog post was submitted by Dr. Katie Gillies, Director, Health Care Assessment Programme & Reader, Health Services Research Unit/School of Medicine Medical Sciences and Nutrition, University of Aberdeen.


 

‘….informing participants of results needs to be part of the plan early on doesn’t it because you know, if we can think about what journal we want to put it in and what conference we want to go to then we can think about how we’re going to actually engage with the people that have made the study possible.’’

Trials wouldn’t be possible without participants. People, often patients, who give up their time, who may be exposed to additional risks, and who provide data (e.g. through a questionnaire or a clinic visit) to help determine which treatments work. Whilst most trial teams consider what information they should share with participants when approaching them to participate in the trial, many fail to consider how they should tell participants the results of the trial. In fact, some research studies have shown that whilst trial teams may have good intentions, only 27% actually provided their participants with the results at the end of the trial. Let’s now consider those trials whose teams reported they would share results with participants. Across the board the ‘results’ that tend to be shared with participants are the scientific paper reporting the main findings, with all the statistical and clinical jargon.

But this situation is changing. There have been a number of research studies investigating how trial results are shared with participants and whilst a ‘best’ method hasn’t been identified, opportunities for improvement have been.

Our group recently completed and reported on the RECAP project (REporting Clinical trial results Appropriately to Participants). RECAP worked with public contributors, trialists, sponsors, research funders, regulators, ethics committee members to co-produce evidence informed recommendations to support trial teams to share results with participants. You can read the full (hopefully not to jargon heavy!) paper here. To give you the highlights, RECAP recommended that results summaries for trial participants should cover four core questions:

  1. What question the trial set out to answer?
  2. What did the trial find?
  3. What effect have the trial results had and how will they change National Health Service/treatment?
  4. How can I find out more?

This content should be developed in consultation with trial participants and also consider how the information will be shared (i.e. a letter, an email, in person) and when (i.e. after publication of the results). It was also recognised that ensuring that appropriate funds were requested and a plan for sharing at the start of the trial to deliver this would also help ensure it actually happened.

The job isn’t finished yet though. In order to provide high quality evidence on what the best methods for sharing trial results are we need to evaluate it in practice.  A recent study did a great job of this within a trial of chemotherapy regimens for ovarian cancer.  We need more studies evaluating these approaches, and patient input into what outcomes we should use to determine this has been done well, such that we can confidently say which approach is better for participants.

So what can you do now? If you are a patient being approached to take part in a trial or a participant actively enrolled in a trial, ask your trial team how results will be made available to you at the end and if those answers are vague, point the team in the direction of the RECAP study.  If you are a trial team member – read our RECAP study! Trials wouldn’t happen without participants and they should be amongst the first to know the results of the research that they made possible.

About Katie – @GilliesKatie is a Reader and Programme Director for the Health Care Assessment Programme at the Health Services Research Unit (@hsru_aberdeen), University of Aberdeen, UK. Katie’s research interests lie in generating evidence to improve the design and delivery of clinical trials to make them more participant centered.


CTO wishes to thank Dr. Katie Gillies for sharing this blog as a part of #TalkClinicalTrials, a campaign led by Clinical Trials Ontario with support from many voices to build awareness of clinical trials. Why? Because clinical trials matter to all of us. They help to generate better treatments and technologies and ultimately help shape the future of medicine. Read more of the #TalkClinicalTrial blog posts here.

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