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Education of health conditions in RCTs boosts recruitment

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By Nick Taylor+

15-Nov-2010

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.

Placebo

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.

Limitations

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.

3 comments (Comments are now closed)

Recruitment article

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

Dan

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Posted by Dan Weddle
18 November 2010 | 20h13

@Dan Weddle

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.

Cheers,

Nick

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Posted by Nick Taylor
16 November 2010 | 20h42

SiteAvail comments

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!
Dan
508-653-5349

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Posted by Dan Weddle
16 November 2010 | 19h35

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