Public involvement in healthcare research is now well established (1–3). For clinical trials, there is good evidence that this improves the relevance of the studies to patients and their clinicians, and improves their quality (1,3). Nevertheless, there is often little public involvement in deciding which trials should be conducted. Decisions about how research funds should be spent, and what trials should be done, are usually made by researchers; with little input from the public. For example, many research funding bodies operate in a responsive mode, relying on researchers to submit their ideas and then using a process of peer review by other researchers to decide which applications to fund.
An alternative, but challenging, approach is to find out what questions patients and the public would want to address in randomised trials and then seeking research that will answer these questions. This can be done. For instance, the James Lind Alliance in the UK has developed methods for bringing patients and clinicians together to identify and prioritise what they call ‘treatment uncertainties’, in order to inform publicly funded research (4). As just one example of how this approach can potentially influence the research agenda, when it was used for urinary incontinence, 5 of the top ten 10 priorities came from clinicians, 4 from patients, and 1 from researchers (5).
Once patients and members of the public have been involved in identifying and prioritising the questions for which randomised trials are needed, they may decide they would like to help make these trials happen. They may also want to get involved in doing the trials. Currently, researchers often look for public involvement in the trials they – the researchers – want to do (3,6). In the future, it seems likely that we will have members of the public looking for researcher involvement in trials they – the public – want to do.
Trials led by patients and members of the public could overcome some of the traditional hurdles to success, such as making sure that people eligible for a study know about it, and understand its aims and what participation would involve (7); finding strategies for keeping in touch with people in the trial until their follow up is complete; checking that any questionnaires are understandable and easy to complete and return; making sure that results of the study are available to the people to whom they are relevant; and helping ensure that the results are implemented into health care (3). To misquote Abraham Lincoln, we need to strive for “clinical trials of the people, by the people, for the people”.