What Motivates Patients To Enroll In Clinical Trials?
6 CommentsBy Ed Silverman // August 31st, 2010 // 7:49 am
Drugmakers regularly complain that it is getting more difficult and more expensive to recruit people into clinical trials, hence the rush overseas (background here and here). So how should a drugmaker or clinical research organization entice prospective participants? A new survey finds some companies succeed by simply appealing to the need people have to receive an otherwise unavailable treatment, or to a feeling of altruism.
But let’s get down to the numbers: as the chart indicates, the most effective pitch is offering a treatment that represents an improvement, following by the convenience of the trial site, the prospect of receiving a free med, tinkering with the number and frequency of site visits and a short trial duration, according to the survey from CuttingEdge Information, which canvassed 84 companies, including drugmakers big and small, CRO’s and companies specializing recruitment. One trial manager interviewed noted that, in urban settings, compensation was a motivating factor, but in rural settings, altruism is a driving force among people who are willing to go out of their way to further understand a disease or do something to give back.
“Recruitment managers will make better decisions if they have a solid understanding of the patient population’s demographics,” the report advises. “For example, will patients have young children and require child care for each visit? If the trial is for prostate disease, which usually affects older patients, is offering free child care not as important? (And the answer is….) Are many of the patients unemployed or on disability? Do patients’ jobs require that any site visits take place after 7 pm?”
Which items are not huge motivators? Transportation, oddly enough. Compensating for travel is certainly a benefit, but it doesn’t appear to register highly as a motivator. And while some people consider themselves to be professional guinea pigs and earn part of their living from participating in clinical trials (see here), monetary compensation, generally, didn’t rank high as a way to motivate people, at least in the experience of those surveyed.
Greg Pawelski
What could motivate patients to enroll in clinical trials is better clinical trial design.
It is said that the statistical method used nearly exclusively to design and monitor clinical trials (the frequentist method) is so narrowly focused and rigorous in its requirements that it limits innovation and learning. The frequentist approach to clinical trials has to do with how each method deals with uncertainty, an inescapable component of any clinical trial.
Unlike the frequentist methods, Bayesian methods assign anything unknown a probability using information from previous experiments. The Bayesian methods make use of the results of previous experiments, to do continuous updating as information accrues, whereas the frequentist approaches assume they have no prior results. Clinical trial design applying Bayesian adaptive randomization can be the first step toward personalized medicine.
A recent report from the Institute of Medicine (IOM), which was commission by the NCI to review its Clinical Ttrials Cooperative Group (CTCG), stated that improved treatments will be delayed and patient lives will be lost unless the efficiency and effectiveness of the clinical trials system improves.
At issue are concerns the CTCG program can’t conduct timely, large-scale, innovative trials needed to improve patient care. The average time required to design, approve and activate a trial is two years, and only about half of all trials undertaken are completed. Meanwhile, funding since 2002 had dropped 20 percent.
To remedy the problem, the IOM says the CTCG needs to better respond to emerging scientific knowledge, involve broad cooperation of stakeholders, and leverage evolving technologies to provide high-quality research that can change practices.
pharmavet
Clinical trials are like drug rehabs; they get a high frequency of repeat customers. If a patient feels he/she has benefitted from a previous drug trial at a particular site, they may be more likely to enroll in a future trial at the same site.
M. Black
Money.
MB
M. Black
It’s been shown in urban environments, especially those that pose a danger to walk to, unsafe transportation, etc patients are deterred from utilizing health clinics, emergency rooms, university health clinics for actual health issues. The risk, to these people, is higher than actually GETTING TO facilities where trials are held.
It’s also been shown, that clinics with mainly Hispanic nurses and doctors is a deterrent for black patients, and clinics run primarily by black nurses and doctors comprise a deterrent for Hispanic patients.
Source: Me. I performed a study on this as part of my Masters Degree program. Research took place in centers in Newark.
Any more info, and I’ll have to charge you ;-)
~M.Black
pharmavet
M. Black, you said it in a nice way, but if it’s the same medical center in Newark that I’m thinking of there have been stories for many years about racial preferences in treatment, and your thesis work supports this notion. Unfortunate but true. If, God forbid you ever have to be hospitalized where I’m talking about, I know from personal experience that you had BEST have a private duty nurse, even if you have to pay out of pocket. It may be a matter of life or death, and in my family’s case almost resulted in a fatal drug dispensing error. Hopefully the financial corruption on a massive scale that has been going on there for many years will put this institution out of business.
Dan Sfera
The reasons that motivate people to join clinical trials are as diverse and varied as the trials themselves. In Phase 1 healthy volunteer studies, there is really no other reason but the almighty dollar. What other benefit can a healthy person get from joining a clinical trial? In phase 2 and 3 studies, money is also a factor but what i’ve noticed is that usually, the more chronic and discomforting the medical condition is, the less motivation money may play in the participant’s decision making process. When the medical indications are chronic, better treatments and the propect of finding a cure play enormous roles in the participant’s motivation. Of course, getting NEW, research naive people to join studies requires a combination of motivating factors, but repeat trial participants only need one motivating factor to try a trial again. It may be money or simply a desire to find a better treatment option.