When participants get involved: reconsidering patient and public involvement in clinical trials at the MRC Clinical Trials Unit at UCL

Abstract

BackgroundPatient and public involvement (PPI) in clinical trials aims to ensure that research is carried out collaboratively with patients and/or members of the public. However, current guidance on involving clinical trial participants in PPI activities is not consistent.MethodsWe reviewed the concept of participant involvement, based on our experience. Two workshops were held at the MRCCTU at UCL with the aim of defining participant involvement, considering its rationale; benefits and challenges; and identifying appropriate models for participant involvement in clinical trials. We considered how participant involvement might complement the involvement of other public contributors. Both workshops were attended by two patient representatives and seven staff members with experience of PPI in trials. Two of the staff members had also been involved in studies that had actively involved participants. They shared details of that work to inform discussions.ResultsWe defined trial participants as individuals taking part in the study in question, including those who had already completed their trial treatment and/or follow-up. Because of their direct experience, involving participants may offer advantages over other public contributors; for example, in studies of new interventions or procedures, and where it is hard to identify or reach patient or community groups that include or speak for the study population.Participant involvement is possible at all stages of a trial; however, because there are no participants to involve during the design stage of a trial, prior to enrolment, participant involvement should complement and not replace involvement of PPI stakeholders. A range of models, including those with managerial, oversight or responsive roles are appropriate for involving participants; however, involvement in data safety and monitoring committees may not be appropriate where there is a potential risk of unblinding.Involvement of participants can improve the trial experience for other participants; optimising study procedures, improving communications; however, there are some specific, notably, managing participant confidentiality and practicalities relating to payments.ConclusionsParticipant involvement in clinical trials is feasible and complements other forms of PPI in clinical trials. Involving active participants offers significant advantages, particularly in circumstances where trials are assessing new, or otherwise unavailable, therapies or processes. We recommend that current guidance on PPI should be updated to routinely consider including participants as valid stakeholders in PPI and potentially useful approach to PPI.

“PROUD to have been involved”: an evaluation of participant and community involvement in the PROUD HIV prevention trial

“…PPI including participant involvement in PROUD was approved as part of the REC approval for the trial (REC: 12/LO/1289). This is discussed in our previous publication [10]. The surveys were completed anonymously, and those completing them consented to the results being analysed and published.…”

“…They have also identified challenges posed by PPIfor example power-struggles and conflict in decision-making, managing confidentiality, prioritising of opinions, and resources. However, very little has been reported regarding the impact of involvement of trial participants in PPI [10].…”

“…The involvement of both participants and community representatives in PPI is seemingly uncommon in the UK. The current INVOLVE guidance says involving participants is usually not appropriate due to concerns that it will "compromise both the researcher and the person involved" [21], although our experience in PROUD has led us to call for INVOLVE to reconsider this advice [10]. PROUD is the first example of such involvement in a UK clinical trial that we are aware of, however in sub-Saharan Africa, particularly in relation to HIV clinical trials, such an approach is more commonplace.…”

“…For the purpose of this study, we use the INVOLVE definition of patient and public involvement (PPI): "Research being carried out 'with' or 'by' members of the public rather than 'to', 'about' or 'for them'" [8]. A range of PPI models were implemented throughout the design, implementation, analysis and dissemination phases of PROUD, which have been previously reported [9,10] and are summarised in Table 1. Community representatives from regionally diverse HIV and gay men's sexual health charities were invited to join an e-group along with researchers, clinicians, commissioners and policy makers, to design a trial that was both acceptable to potential participants and able to address the relevant research questions and ultimately to influence policy and practice.…”

“…Therefore PROUD took the decision to aim to involve trial participants. Participants were uniquely placed to represent the wider study population, provide perspectives of individuals who may potentially benefit from the research results, and (because PrEP was not available in the UK at that time) provide unique, first-hand experience of using (or wanting to use) PrEP [10]. PROUD involved participants through a range of approaches, including face-to-face meetings, teleconferences, webinars and email.…”