Clinical trials involve millions of participants worldwide and are a multi-billion pound enterprise. At the current time, international registers show that there are over 200,000 trials actively recruiting participants in over 190 countries around the world. In England alone the costs of clinical trials are around £6 billion annually and include over 600,000 people each year.  

A core tenet of clinical trials is the timely and effective return of trial results to participants; however, the routine sharing of research results with trial participants is rare. When information is fed back it is often very poorly done. Practice is highly variable and has been known in some cases to cause harm. There are often hundreds of thousands of participants waiting to hear about the results of the trials they took part in. Yet the routine sharing of results with trial participants is uncommon, despite the evidence that feeding back results improves participants’ experience and encourages future participation. There is an urgent need to address this poor practice. Yet the details of the “what”, “how”, “by whom” and “when” of results feedback, has not been evidenced appropriately with trial stakeholders (specifically participants but also research ethics committees, industry, funders, etc). Existing studies have called for ‘clear guidelines’ and ‘ethical frameworks’ generated from empirical data as an appropriate way to inform sharing results meaningfully with trial participants.

This project (funded through the Academy of Medical Science’s Springboard scheme) aims to generate participant-centred, evidence-based recommendations for trialists to implement the dissemination of results to trial participants.  The specific objectives are:

  1. Explore and evaluate the range of methods for feeding back results to trial participants that are currently used, appraising the advantages and disadvantages of each.
  2. Determine consensus amongst trial stakeholders (participants, trialists, industry representatives, regulators) surrounding key content of trial feedback.
  3. Explore trial stakeholders' views and perceptions about how trial feedback is delivered.
  4. Develop practice recommendations for feeding back results to trial participants.

Identifying current practice and determining what should be delivered and how (in ways that are individually appropriate and responsive) would be a demonstrable step forward in realising and fulfilling the ethical and regulatory requirements. There is significant potential for the results of this research to improve trial participants' experience and encourage participation in future trials.





Bruhn, H., Cowan, EJ., Campbell, M.K. et al. Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review. Trials 22, 361 (2021).

Raza MZ, Bruhn H, Gillies K. Dissemination of trial results to participants in phase III pragmatic clinical trials: an audit of trial investigators intentions BMJ Open 2020;10:e035730. doi: 10.1136/bmjopen-2019-035730