Shifting research culture to address the mismatch between where trials recruit and where populations with the most disease live: a qualitative study

Abstract

Background Research participation is beneficial to patients, clinicians and healthcare services. There is currently poor alignment between UK clinical research activity and local prevalence of disease. The National Institute of Health Research is keen to encourage chief investigators (CIs) to base their research activity in areas of high patient need, to support equity, efficiency and capacity building. We explored how CIs choose sites for their trials and suggest ways to encourage them to recruit from areas with the heaviest burden of disease. Methods Qualitative, semi-structured telephone interviews with a purposive sample of 30 CIs of ongoing or recently completed multi-centre trials, all of which were funded by the UK National Institute of Health Research. Results CIs want to deliver world-class trials to time and budget. Approaching newer, less research-active sites appears risky, potentially compromising trial success. CIs fear that funders may close the trial if recruitment (or retention) is low, with potential damage to their research reputation. We consider what might support a shift in CI behaviour. The availability of ‘heat maps’ showing the disparity between disease prevalence and current research activity will help to inform site selection. Embedded qualitative research during trial set up and early, appropriate patient and public involvement and engagement can provide useful insights for a more nuanced and inclusive approach to recruitment. Public sector funders could request more granularity in recruitment reports and incentivise research activity in areas of greater patient need. Accounts from the few CIs who had ‘broken the mould’ suggest that nurturing new sites can be very successful in terms of efficient recruitment and retention. Conclusion While improvements in equity and capacity building certainly matter to CIs, most are primarily motivated by their commitment to delivering successful trials. Highlighting the benefits to trial delivery is therefore likely to be the best way to encourage CIs to focus their research activity in areas of greatest need.

A systematic review examining socioeconomic factors in trials of interventions for men that report weight as an outcome

“…While a policy priority in many countries, 53,54 socioeconomic factors may not always be a top priority for researchers who design and evaluate (weight management) interventions. A recent qualitative study found that although trial Chief Investigators deemed matters relating to equity to be important, the majority were primarily motivated by a commitment to delivering successful trials efficiently 113 . Undertaking trials in less research‐active sites, with higher disease prevalence and lower socioeconomic status, could be seen as a risk to trial success 113 .…”

“… 113 Undertaking trials in less research‐active sites, with higher disease prevalence and lower socioeconomic status, could be seen as a risk to trial success. 113 In the current review, this may be reflected by the majority ( n = 20) of trials making no specific mention of the socioeconomic profile of their study sample in relation to strengths or limitations. Moreover, this could also point to the need for a shift in the way that researchers report on the socioeconomic profiles of study samples, and how this information is contextualized in relation to intervention reach, trial outcomes, and the potential for interventions to positively (or negatively) impact health inequalities.…”

“…A recent qualitative study found that although trial Chief Investigators deemed matters relating to equity to be important, the majority were primarily motivated by a commitment to delivering successful trials efficiently. 113 Undertaking trials in less research-active sites, with higher disease prevalence and lower socioeconomic status, could be seen as a risk to trial success. 113 In the current review, this may be reflected by the Due to the heterogeneity of socioeconomic measures across studies and countries, moderation analysis of socioeconomic status on weight outcomes and retention rates was not undertaken.…”

“…113 Undertaking trials in less research-active sites, with higher disease prevalence and lower socioeconomic status, could be seen as a risk to trial success. 113 In the current review, this may be reflected by the Due to the heterogeneity of socioeconomic measures across studies and countries, moderation analysis of socioeconomic status on weight outcomes and retention rates was not undertaken. In addition, heterogeneity of measures makes it difficult to make conclusions about the socioeconomic profiles of study samples.…”

Enrolment in clinical research at UCLH and geographically distributed indices of deprivation

“…One approach is to promote equity in innovation through reason-based interventions, such as distributing research activity closer to the populations it serves 8 . But any intervention here is in as much need of empirical evidence as the novel treatments research aims to discover.…”