Overcoming Barriers to Clinical Trials
There’s lots of talk in the research world about clinical trials, how hard it is to recruit patients, and the accompanying inability to meet the research goals. How often have we heard or read ‘we couldn’t get enough patients to enroll so the clinical trial ended’ without an additional explanation as to why that might happen. This probably happens more often than we would think because failures in clinical trials aren’t discussed often in public.
So what is it that keeps us from participating? Those obstacles, also called barriers to participation, are varied. Some are very basic such as concern if we will be guinea pigs for experimental treatments or if the trial might cause us harm. Trust is also a big barrier – if a person does not trust the researchers or even the process of clinical trials, they are much less likely to participate in a trial. Clinical Trials Recruitment and Enrollment: Attitudes, Barriers, and Motivating Factors offers an excellent summary of some of the literature done on barriers to participation.
There are also the very practical, logistical barriers to participation such as out of pocket costs, transportation issues, or difficulty with obligations such as work schedules and child care. I recently came across a company, Clincierge®, that aims to handle the hospitality side of clinical trials, freeing the research staff to focus on the delivery of medical care.
The idea is so simple it is hard to understand why no one has done this before – the Clincierge® care coordinator establishes a relationship with the person (subject) participating in the clinical trial, makes sure all of their transportation needs are handled seamlessly, prepays things like food vouchers and housing if there is to be a long stay, and will even arrange a translator if the person needs one. According to Scott Gray, CEO of Clincierge®, their first work in this area was a rare disease trial in 2014, conducted in London, and drew from a very small population of people with this disease, from around Europe and other continents. The language barrier was a significant problem, and the subjects were appreciative of having their native language available through translators to talk with the researchers and better understand what was going to happen to them. He pointed out this helps to build on the trust in the relationship between the researcher and person, too.
I related to Scott my own personal experience with a trial that left me wondering if I will ever do one again because it required me to take time off of work to go to the clinic, use my own auto and gasoline, and it had minimal reimbursement compared to my real out of pocket costs. The concern I have voiced more than once is the pharmaceutical companies and the research sites all have their costs covered, and only the patient/subject is inconvenienced and subsidizing the trials. There is something wrong with this model and the work done by Clincierge® addresses these shortcomings.
Scott said from their early clinical trial experience they have seen improved rates of people remaining in trials rather than dropping out due to barriers, and by keeping more people in trials the research work can be completed faster. If the work is done faster, and the results are positive, then new drugs can come to market sooner. Clincierge® got its official launch in June 2015 and now is supporting 40 clinical trials. For now, their work is mainly in the rare disease area and does not include any multiple sclerosis trials, but has included a study on jet lag and another on post-partum depression.
This leads me to ask if any of you reading this have encountered barriers to helping with research and what those might have been. I think it is an important topic and I would love to hear more of your thoughts.
Wishing you well,
Do you have a fear of needles and take medication that requires injection?