There are over 380,000 registered clinical studies in all 50 states, ClinicalTrails.gov reports. Of those studies, 34% of U.S.-based ones are actively recruiting. However, according to the National Institutes of Health, 80% of clinical trials fail to meet their expected enrollment size. What’s leading to this recruitment challenge?
There are some common themes that clinical trial sponsors and CROs face when recruiting patients for a new study. Fortunately, with so many active studies across the country, experts in the area can shed light on these barriers and how we can overcome them based on their own experience.
Because 2020 On-site’s mission is to provide accessible treatment through decentralized clinical trials, we wanted to explore what may be holding back potential patients from participating in studies and how we can address these challenges. We’ve uncovered the top three common barriers to patient recruitment with insights from the research community — discover more below.
Jonathan Jackson, a researcher at Massachusetts General Hospital claims “many patients can't afford the costs associated with participating [in clinical trials].” In Jackson’s study, many participants who come to clinical trials in Boston may not live in the area, resulting in costs for flights, hotels, childcare, and time off of work. Even those who live in Boston may not be able to afford the costs of traveling to a research site.
Oftentimes, this cost to participate in a clinical trial can deter prospective patients. Furthermore, patients can become overwhelmed or confused by what is financially expected of them when overloaded with information.
Additionally, by lessening the financial burden on participants, researchers can increase the pool of potential patients. This means sponsors can have a more diverse clinical trial, reaching individuals who truly represent the population they are trying to treat.
One way to combat this challenge is to bring clinical trials directly to the individual. Our mobile vision clinics travel to patients, both assisting the sponsor by sharing or completely owning the transportation expenses while shifting the travel burden away from the patient.
It is an extreme convenience for patients dealing with burdening finances and certain health conditions to access their treatment from their home or more localized areas, including their doctor’s office. 2020 On-site saves both patients and the clinical trial itself time and money by traveling directly to the patient.
John Brownstein, CIO of Boston’s Children Hospital states, “We have a massive number of no-shows and transportation plays a really critical role. And when you look specifically at clinical trials, we have major issues with dropouts and we know some of those are just about logistics, just about getting to those trial sites."
According to one study, geography and the distance to the clinical site was the main barrier for trial participation for 60% of patients. This is especially true if the study requires multiple follow-up appointments a month or involves multiple locations for endpoint collection, requiring patients to take time out of their day to get treatment.
Even if the site is relatively close to a patient’s home, the process of traveling to be seen by a doctor still requires effort and time. Someone taking local transit to a site may still need to take time off work to account for station changes or certain bus schedules. Those depending on a ride from a loved one must wait to be picked up and dropped off. All of these actions, no matter how close patients live to research sites, take time out of their day.
It’s not just about resolving the long-distance travel for faraway patients, but also reducing the stress for local patients who have to adjust their normal routines to participate in a trial. Following a decentralized approach to clinical trials — especially with the use of mobile clinics — will alleviate these burdens, allowing patients to access treatments no matter where they live.
If no one has heard of a clinical trial, how will they know to enroll? This is a common barrier for patient recruitment: awareness of the trial occurring. Once patients are diagnosed with a disease, they most likely will be communicating directly with their doctor or specialist for treatment opportunities.
Craig Lipset, founder of Clinical Innovation Partners and former head of clinical innovation at Pfizer, notes, “many trial recruitment campaigns may think reaching patients directly is more ‘patient-centric.’ But not giving patients tools to have conversations with their treating doctor is doing those patients a disservice.”
In addition to the lack of awareness, there is an opportunity to improve communication with patients before a trial begins. This dialogue can answer questions such as:
Mark Summers, President of Patient Engagement at WIRB-Copernicus Group (WCG) states, “if you're maintaining ongoing communication with the patient, you're going to greatly reduce the chance of lost follow-ups.” Without clear communication, patients can feel lost or confused which increases likely dropout rates.
Conclusion: Overcoming Patient Recruitment Barriers
UT Southwestern Professor Dr. Celette Skinner states that “Before we can figure out how to improve accrual in trials, we need to better understand the entire process and challenges along the way.”
Common barriers like financial costs, travel time, and miscommunication can greatly impact the speed and success of patient recruitment. At 2020 On-site, we use a patient-centric approach to provide access for all prospective individuals interested in participating in a clinical trial. Our goal is to help sponsors and CROs achieve their clinical trial goals while improving the patient experience.
Interested in learning more about 2020 On-site’s contribution to decentralized clinical trials? Read more here.