Low enrollment and patient diversity remain two of the largest challenges in the clinical research industry, and standard solutions are falling short in addressing them. One 2020 study on recruitment and retention challenges discovered that 55% of clinical trials are terminated due to low enrollment rates, and 80% of trials fail to enroll on time, resulting in extensions and increased costs for sponsors.
So, what are the underlying causes of low enrollment and the lack of diversity? It’s easy to say that patients just aren’t interested in clinical research, but it’s not that simple. There are a variety of reasons patients don’t enroll at all or fall off at some point in the enrollment process, and oftentimes, preventing their disinclusion is completely within the sponsor’s control.
Causes of Low Patient Enrollment and Retention in Clinical Trials
Complex Enrollment Requirements & Lack of Focus on the Patient Experience:
Of course, sponsors have to follow a set of regulatory requirements when creating a study, which is laden with industry jargon and legalese. Unfortunately, there is little effort dedicated to “translating” this material for patients learning about the study for the first time. The result? Dense resources that are completely unapproachable to the layperson, which causes fear, uncertainty, and doubt.
Think about buying a car and the angst that arises when you have to sign the final documents. You’re making a big decision without fully understanding the terms because in order to understand those terms, you’d have to sit down with a car industry expert and a dictionary.
The same goes for clinical trials. Although a lot of the material is required by the FDA for patient protection, it could be optimized to improve the patient user experience.
The logistical requirements of clinical trials can be demanding for many patients. Travel and transportation are deterring factors, especially if patients are expected to report to a research site on a frequent basis. Although decentralized trials are becoming more popular, they come with their own set of logistical challenges such as at-home visits and blood draws. Longer studies become an issue because patients may have a hard time adhering to the requirements for an extended period of time or their circumstances (i.e. living situation) may change and prohibit them from finishing the study.
Although sponsors are working to improve patient convenience and often provide solutions to do so, this information is often not obvious to patients at the time of enrollment, causing them to opt out of participating at all.
Failure to Meet Patients Where They Are:
The issue is not that patients aren’t interested in clinical research. The issue is that sponsors are not willing to adapt recruitment strategies and embrace more modern approaches to meet patients where they are. Many of the advertisements attempting to recruit patients lack effective messaging and design, and they are often not targeted correctly to appear in front of the right audience. And even if patients make it to the enrollment website, they are often deterred from going further due to poor conversion strategy.
Solutions to Low Patient Enrollment and Retention
Improve Enrollment Resources & Solve Easy Logistical Barriers:
Sponsors can improve the enrollment process and increase recruitment numbers by approaching the process from both logistical and experiential perspectives. Logistically, sponsors can offer solutions to travel issues like Uber Health, in-home blood draws, or transportation to the research site. Although this increases the cost of the trial overall, it increases convenience for the patient and overcomes early logistical barriers.
When it comes to learning more about the study and reviewing enrollment materials, sponsors can present patients with more approachable resources that aren’t laden with legalese and industry jargon. Pro-ficiency’s patient education solutions include videos, animations, and 3D modeling that are proven to improve retention, reduce anxiety, and answer a patient’s top question, which is what should I expect from this study?
When it comes to international studies, sponsors should ensure the moderators and patient-facing staff reflect the diversity of the audience they are trying to attract. This will serve to address any cultural nuances, and will also help ease the anxiety associated with historical mistrust in the clinical trial industry.
Improve Outreach and Communication Methods:
Sponsors will see an improvement in enrollment by optimizing communication with patients as well as site team members. Several ways sponsors can enhance the patient experience from the very beginning are to:
- Optimize messaging and design in digital advertisements and on website landing pages to encourage enrollment. Address patient concerns upfront, tell them why the study is good for them, and provide information about logistics.
- Diversify the platforms where these ads are served to target a diverse audience. Don’t just focus on Facebook and LinkedIn. Look to platforms like YouTube, TikTok, and Discord to find patients of different ages and backgrounds.
- Modernize the approach to study screening to minimize the drop off between when a patient shows interest and when they are approved for participation. Prioritize methods like text and email over phone calls.
Although enrollment is a looming and costly issue in the industry, it is solvable. Pro-ficiency is dedicated to helping sponsors overcome these barriers by offering solutions such as:
- Enrollment optimization, which uses simulation-based training to expedite enrollment, help sites gain a full understanding of their screening process, and reduce unwarranted subject loss.
- Patient education services also provide easy-to-access materials with video, animation, and 3D modeling to help participants understand their role in a study, and teach them how to execute potentially confusing tasks, which reduces dropout rates.
- Study support tools such as virtual investigator meetings, rapid communications capabilities, and post-training support help enhance the efficiency and effectiveness of a site team and a protocol to increase enrollment retention and study efficacy.
To learn more about how Pro-ficiency can help sponsors address enrollment issues, click here.
Michael Lang brings more than 25 years of healthcare experience to Pro-ficiency, including 20 years of senior leadership. While scaling, delivering revenue growth and managing change have been hallmarks of his career, Michael is most proud of the impact his high-integrity approach has had on patients. Ultimately, his commercial operations were focused on achieving excellence by developing an intimate understanding of his client’s needs rather than quota which ultimately benefited the patient. As he leads Pro-ficiency through their most recent growth and expansion strategy, the “client-centric” approach is already evident in the high-quality experience clients receive.