Leaflets, adverts and phone calls have all been used to recruit patients in clinical trials with some results. Still, the personal contact remains the most reliable method, if you can get the recruiter to do it. In this post, I explore some of the barriers of clinicians’ recruitment activity in randomised controlled trials.
Lack of time, specialist staff and patient motivation are the most frequently reported barriers that prevent clinicians to recruit their patients into clinical trials. Even though the physician signs up for the study and is informed about what is involved, they often do not complete the job. Some are distracted by competing clinical priorities, while others cannot get a positive answer from their patients. Regardless of the reason, the research suffers because of low participation numbers and prolonged study set-up.
Researchers from the University Of Birmingham, UK, looked at all ways that improve the clinicians’ recruitment activity. Their systematic reviewof scientific literature compared the impact of different recruitment strategies and underlying clinician attitudes. To recruit successfully, the clinicians should be incentivised or supported in some way. Unfortunately, many researchers use supports that don’t work. What’s more worrying is that nobody knows how to boost clinicians’ recruitment rates. The study authors recommend that each clinical trial uses qualitative methods to ask clinicians what would work for them and use their suggestions. Another issue was what clinicians think of clinical trials. Misconceptions about trials methods still prevail and clinicians do not see the positives of trials; nor do their patients. Improved education and communication from researchers to physicians can overcome these issues.
Paying research participants for taking part can increase the number of people who agree to take part in the study, the so-called consent rate. It has become a norm in the Western world studies. Still, some studies and countries are unable to provide financial incentives to patients who volunteer for research. Direct payments may also be viewed as introducing unwanted bias into research results. Some may think that people who get paid for research would not participate if they did not get anything. Human motivation is a mysterious subject and money is part of it. It is the currency of modern society.
Is it ethical?
The healing relationship between the patient and doctor can be viewed as unsuitable for recruiting patients into clinical trials. Patients may feel obliged to agree, without making a fully informed decision. Ideally, the recruitment should be done by someone who isn’t involved in patients’ care; however, this is often not feasible in the real life. On one hand, the participants should make an informed decision about their participation and decide voluntarily. On the other hand, the researchers should not surprise patients who attend medical services for non-research purposes. The way to overcome this problem is through a two-stage recruitment process, as used in our study. The first step is to give information. The care provider gives a leaflet with information about the study to potential participants. The person goes home and reads the leaflet at their leisure. When they come to see their doctor next time, they can ask questions about the study, and decide to take, or not to take, part in the study.
Recruitment to randomised trials will probably always remain an issue for science. With an open mind, the investigators and clinicians can seek better solutions for creating trials that would attract human participants and help advance science for the benefit of all.
Ben Fletcher, Adrian Gheorghe, David Moore, Sue Wilson, Sarah Damery: Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open 2012;2:1 e000496 doi:10.1136/bmjopen-2011-000496
Klimas J, Anderson R, Bourke M, Bury G, Field CA, Kaner E, Keane R, Keenan E, Meagher D, Murphy B, O’Gorman CSM, O’Toole TP, Saunders J, Smyth BP, Dunne C, Cullen W: Psychosocial Interventions for Alcohol Use Among Problem Drug Users: Protocol for a Feasibility Study in Primary Care. JMIR Res Protocols 2013;2(2):e26