Trial professionals brainstorm recruitment solutions
It’s long been a source of frustration among pharma companies: clinical trial participants are needed for testing so new drug products can move forward, but finding viable subjects can be tricky at best, nearly impossible at worst.
The patient-recruitment issue substantially delays FDA approval on potentially impactful drugs. For example, although the number of trials registered on clinicaltrials.gov nearly tripled between 2000 and 2014, 80 percent of those trials failed to meet enrollment timelines. A whopping 50 percent of proposed trials enroll one patient or zero patients.
The main barriers to subject recruitment? A 2015 peer review on Appliedclinicaltrialsonline.com points to a lack of awareness by potentially interested participants and “recruitment methods that have not kept pace with advances in communications and other technologies.” Privacy standards that keep recruiters from identifying those with relevant diseases is another important issue.
But the review also suggests possible solutions. A survey sponsored by public-private partnership The Clinical Trials Transformation Initiative gathers input from several stakeholder groups, including Clinical trial sponsors (industry, federal and academic); Research sites (investigators, coordinators and executive-level staff); and patient advocacy organizations. And 70 percent of those respondents significantly influence recruitment strategies for the trials they manage.
Possible solutions they suggest encompass better education about the research among patients, physicians and research staff; more targeted use of technology; better access to electronic health records; patient and community input into research design; better planning and budgeting; and more flexibility and streamlining of elements like study visits and consent.
More specifics on the findings:
- 81 percent of respondents call the difficulty in finding eligible patients a somewhat or very significant barrier to trials. Ranked next-most significant, respectively, are insufficient staff time for recruitment (67 percent), length/complexity of consent forms (66 percent) and other protocol (60 percent).
- Deemed important by many is relationship building between researchers and clinicians and researchers and patients. Some suggest a “research presence” should be established in clinics, either via on-staff research coordinators, the advertising of trials in waiting room collateral and/or the reaching of patients via electronic alerts. Others suggest patients should be recruited via social media, webinars, trial-matching websites or patient registries.
- Respondents feel the most effective avenues for recruitment are medical records and hospital-based registries or databases, privacy issues notwithstanding. Sending electronic alerts to physicians about clinical trials was planned by 20 percent of respondents’ organizations. Named the least-favorable recruiting venue: public events such as farmers markets or health fairs.
- A broadening of eligibility criteria is suggested. One respondent says some criteria is “needlessly narrow to the point of making few subjects eligible, even if we have many subjects with the disease available.”
- Establishing realistic timelines for trials and clearly communicating expectations is emphasized.
- Simplification of the informed-consent process is recommended.
- More efficient site planning is recommended by many, with feasibility studies conducted beforehand to determine whether sites are conveniently located. “One size does not fit all,” says one respondent. “There needs to be a site-specific recruitment action plan to strategically apply tactics to the site’s own institution, community and patient population.”
- Patient advocacy groups specifically point to the lack of viable transportation to trial visits and overly burdensome out-of-pocket expenses for participants. Most respondents overall advocate for “reasonable” financial reimbursement that can’t be construed as enticement.
- Many point to problematic under staffing of test sites, suggesting job sharing or the addition of part-time positions. The need for more financial resources for staff hiring and training is frequently mentioned.
- Several respondents say sponsor or regulatory requirements often lead to excess or unnecessary data collection or trial procedures.
Much of the healthcare industry continues to study the problem of how to better find clinical test subjects. And the movers and shakers are highly motivated: One report indicates drug manufacturers can lose between $600,000 and $8 million on sales for each day a trial deadline isn’t met, notwithstanding the priceless loss of human life due to delayed therapies.
“This century has truly kicked off with a new era of patient engagement and patient-focused clinical trials,” writes Tina Tockarshewsky on Fastercures.org. “But, like developing the next blockbuster drug, time is of the essence. One can almost hear the clock ticking — ticking off the lives holding out hope (and the lives lost), ticking off the years passing by and ticking off the dollars spent.
“Stakeholders’ frustration and even exasperation with each other and with the process is palpable. But one also senses the excitement and the optimism that new collaborations could yield extraordinary advances.”
Contact Artcraft Health for strategy on recruitment for your upcoming clinical trial.