Patient recruitment is boosted by health condition awareness strategies and financial incentives, according to research, but various methods of randomisation and consent design have no impact.
Tackling bottlenecks in patient recruitment is essential for biopharm attempting to cut costs and time spent on randomised controlled trials (RCT). To establish the effectiveness of recruitment strategies researchers performed a systematic review of 37 RCTs that used various methods.
Findings from the research have been published in PLoS Medicine . Strategies employed in the 37 RCTs cover all steps in the recruitment process, such as trial design, randomisation, provision of information, and recruiter differences.
The review showed strategies to increase potential participants’ awareness of the health problem being studied increased consents in both real and mock RCTs. Such strategies engaged people in the learning process using questionnaires, educational sessions, videos and interactivity.
However, when similar strategies were used to educate potential participants about the clinical trial process no boosts to recruitment rates were observed. Furthermore, the review suggests how or when information is provided to patients has no impact on recruitment rates.
This finding contrasts with an earlier observational study that found emphasising uncertainty when framing information increased recruitment. Furthermore, the researchers expected the role of the recruiter to influence rates but the systematic review found no evidence to support this.
Also, a separate piece of research , published in the Journal of Clinical Epidemiology after the systematic review finished, found no evidence publicity increases recruitment rates. The study included a newspaper article with some information sheets to assess the impact of publicity.
The systematic review shows a non-inferiority clinical study, where all patients receive active treatments, had higher consent rates than a placebo-controlled trial. This is consistent with previous research.
Furthermore, patients were more willing to participate in non-blinded trials which let them know if they are receiving a placebo prior to signing the consent form. However, higher drop out rates in the treatment arms of the study “is likely to jeopardise the validity of the results”.
Also, in mock clinical studies increasing the likelihood of receiving the experimental treatment appeared to have no effect on consent rates. However, extrapolating the results of mock studies to real-world trials may be unrealistic and this is one of a number of limitations to the review.
Around 50 per cent of the studies included in the systematic review took place in the US and many others were performed in developing countries. Consequently, results may be less applicable to other regions, in particular emerging markets.
However, despite these limitations, the researchers believe the results can be used to support further evaluation and investigation into recruitment strategies. Performing this work will help biopharm and contract research organisations (CRO) reduce the likelihood of slow recruitment.