By Duncan Reynolds
Can recruitment be reimagined so trials are found for participants, rather than the other way around?
In a recently published work, Duncan Reynolds and colleagues show how a clinical trial centre in London addressed recruitment challenges by inverting conventional recruitment logic.
Traditional clinical trial recruitment
Finding participants is one of the main barriers to the timely and successful running of clinical trials. Poor recruitment can lead to many issues, such as delays, which often leads to greater financial resources being put into the trials. Only 20% of clinical trials are completed on time, and difficulty in recruitment has been argued as a major reason for why with the average recruitment period being 4-5 years. Traditionally, recruitment for clinical trials falls into the category of “finding participants for trials”, where the logic is that there are specific trials with specific inclusion and exclusion criteria, and people who fit these must be found. Potential participants are recruited for a specific trial, screened, and either consented onto the trial or rejected.
Recently, some patient-centred approaches have begun to reverse this thinking, where matching trials to participants rather than hunting participants for trials becomes the norm. Research by Duncan Reynolds and colleagues offers a striking example of how one London clinical trial centre put this into practice.
Inside the research
The research was guided by the question: how does a clinical trial centre with a good record for recruitment find participants for trials through the flipping of the recruitment logic?
Over 17 months, the researchers conducted ethnographic observations and interviews at a highly successful trial centre in London. This centre was chosen because of its experience and success in running clinical trials. For example, it was the highest recruiting centre for a large, transnational, long-term, hypertension study. As a result, the local area has seen rapid decline in cardiovascular event rates, and an improvement of around 300% above the national average. The study followed three hypertension trials, documenting 353.5 hours of observation, 322 minutes of recorded interviews, and many informal conversations with staff and participants.
The flipped logic of recruitment
Findings showed how The Centre engaged in traditional recruitment such as through newspaper adverts and via other medical settings. However, in addition to these The Centre also actively sought to find trials for participants. What this meant is that instead of finding participants who met the inclusion criteria (and did not meet the exclusion criteria) for specific trials, when people expressed an interest in a trial at The Centre, a lot of work was done to find a trial that was appropriate for by explaining a range of options to them. This was not a one-off action, but a strategy to aid recruitment.
This was seen through the offering of multiple trials to participants. On potential participants’ first visit to the Centre, the staff would explain the trials they had come to The Centre for and also inform them about the other research being done at the site. This recruitment strategy was also used when the participants were nearing the end of the trial they were currently on. Staff were observed casually mentioning to participants that they may have another trial at The Centre for which they might qualify. If the participants responded positively to this, more information was given, and the participant’s information would be passed on to the relevant clinician (with permission from the participant).
The full paper shows this in action through the stories of multiple participants who were recruited or attempted to be recruited at The Centre. Stories such as Mr Lisbon, who joined three trials one after the other, and Ms Rabat, who did not successfully join any trial but screened for many different ones at The Centre.
Looking forward
The research concludes with a caution that the flipping of the logic of recruitment had the potential to be used as a strategy to improve the representation of traditionally underserved groups in clinical trials. This could be achieved as a participant with such a background comes for a trial or completes one, then they could have other trials found for them, thus keeping them in research and helping to redress existing imbalances in who partake in trials.
However, there was also potential for negative impacts of the reversed logic on representativeness as it is possible that staff may enact their own biases and see “suitable” or “good” participants as those who, for example, conform to their own cultural and social norms.
The full research can be accessed here.