Education of health conditions in RCTs boosts recruitment

By Nick Taylor

- Last updated on GMT

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.

Related news

Related products

VDS groß

Meet the challenges of complex injectables

Vetter Pharma International GmbH | 07-Nov-2017 | Technical / White Paper

In the time it takes from the exciting discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can...


Process Development for Lyophilized Products

Baxter BioPharma Solutions | 30-Oct-2017 | Application Note

Baxter approaches formulation and process development with the intention of identifying the failure points for the product. Knowing where the product fails...


Advancing therapeutics for myeloma

Recipharm AB | 04-Sep-2017 | Case Study

Multiple myeloma is the second most common blood cancer in the world and despite survival rates increasing over the last decade, there remains a requirement...

Related suppliers


Recruitment article

Posted by Dan Weddle,

Thanks a bunch, Nick, and have fun at AAPS with all the scientists!!


Report abuse

@Dan Weddle

Posted by Nick Taylor,

Hi Dan,

Thanks for your interest in the article - you're welcome to link to it. I'm at AAPS this week but am happy to talk next week if there's anything you'd like to discuss.



Report abuse

SiteAvail comments

Posted by Dan Weddle,

Hi Nick - Interesting article on relationship of health education to patient recruitment for clinical trials. I am interested in how the health education video was delivered/shown to patients. As you might recall, I offer a Video Ad Network (VAN) aggregation service in US + Canada where patient recruitment video can be narrowcast to medical offices proximal to principal investigators, and this information will be of extreme importance to development of my model. Most patient recruitment-oriented video is 30-60 seconds in length; however, I've been approached by one large pharma company that inquired about ability to deliver a 3-minute video that has more health education in it than a recruitment perspective, albeit with a URL + toll-free tel# for patients to respond to recruitment opportunities within a specific therapeutic area. The study you publish here could push us to piloting this 3-min video here in US to test outcome on patient responses to the recruitment message therein.

I'd like to inquire whether I can copy a link to this article within a blog I'd send out on LinkedIn, discussing such opportunity...please let me know.

Thanks for the article!

Report abuse