Eighty percent of clinical trials in the United States fail to meet their patient recruitment timelines [1, 2] and 15-20% of activated clinical trial sites never enroll a single patient.  Meanwhile, 50% of clinical trial sites don’t reach their enrollment goals.  These data make it clear that enrollment is the Achilles’ heel of clinical trials. Before we talk about solutions, we need to understand why we keep getting stuck.
So here are the four key reasons why enrollment is a recurrently painful issue for Clinical Operations Teams:
1. Inaccurate Site Selection and Patient Targeting
Feasibility surveys are full of puffed-up and inaccurate estimates on screening & enrollment rates (especially in new diseases). Although EMRs are improving hospital sites’ ability to efficiently identify patients with clear disease diagnoses, doctors typically have to estimate how many patients would fit specific clinical trial inclusion & exclusion criteria and how many would be willing to participate in a clinical trial. On top of inaccurate PI estimates, Clinical Operations teams often look to outdated databases to make market conclusions. This means teams are operating on potentially old contact information and without any indication of whether these patients are currently interested in participating in clinical trials. This sets up the team with inaccurate information on the patients that are qualified and interested in clinical studies and overestimated enrollment timelines.
2. Lack of Measurability around Recruitment Efforts
Traditional recruitment methods don’t allow you to measure where patient leads are coming from. Without clear data on how many leads your recruitment initiatives are generating, there’s no way to measure the efficacy of campaign adjustments. Some ambitious ClinOps teams, with lots of resources, resort to phone trees or requesting weekly screening logs from their sites in order to get visibility and numbers on the funnel of screening leads. Often a CTA will spend time manually tracking this data in a spreadsheet. All of these antics result in an inefficient use of resources when instead this information could flow into the Seeker PortalTM automatically as patients opt in when they encounter a Sponsor Facebook Ad (made compliant by Seeker Health technology) or your Clinical Trial website. On top of all of this, without launching a massive survey effort, ClinOps teams cannot figure out which of their traditional recruitment methods (pamphlets, posters, flyers, radio ads, newspaper ads, “dear doctor referral letters…) generated the patient leads. Ultimately, teams are spinning their wheels and unable to effectively measure their recruitment campaign impacts on their screening & enrollment pipeline.
3. Lack of Organized, Transparent Communication Systems
As explained above, Sponsors don’t have great visibility into the recruitment pipeline for sites. Both ClinOps teams and Study Coordinators waste time relaying information back and forth on screened patient statuses. On top of this, Study Coordinators don’t have a consistent place to make notes on potential patients’ best times for contact or visit preferences. Without an organized portal for tracking and sharing communications, opportunities for confusion and inaction abound.
4. Lack of Compliance and Controls
Not only do manual phone calls and emails take up a ton of time, they also increase the risk of straying from pre-IRB approved template language for patient communications. Exchanging spreadsheets with leads via email can involve insecure transfer of patient data and pose a risk to patients’ private health information. So moving forward, whether we have a manual solution or a technological solutions, teams need to ensure that there is full compliance and security.
These four issues hold ClinOps Teams back from running maximally efficient recruitment campaigns. Sometimes it’s obvious when teams are stalled. Other times, ClinOps teams believe they are moving forward at an acceptable enrollment clip; however, they don’t realize that they could be connecting with patients faster and completing their trials ahead of schedule. These issues make clinical trials more expensive and hold us back from getting new medicines to patients.
So where do we go from here? A successful enrollment solution must include:
1) Accurate and effective targeting to find patients
2) Automatic data inflow and measurability
3) A streamlined, easy to use referral lead management system
4) Full compliance and security
Thankfully the team of top innovators and industry experts at Seeker Health have figured out how to effectively leverage social media and digital tech to address each of these four issues.
A Seeker Health Campaign can effectively Find Patients, Measure Progress, Drive Action & Value and ensure Compliance & Controls. Here’s how:
To learn more, visit our website here and click "Get Started" to schedule a demo.
By Heather Hernandez
Heather Hernandez is a Director of BD at Seeker Health, a digital health company innovating the way that clinical trials enroll participants. Using technology and social media, Seeker Health helps medicines get developed faster and reach those who need them earlier. Seeker Health specializes in accelerating clinical trials in serious diseases with hard-to-find patient populations, including oncology and rare diseases.
 Data from: Biopharmaceutical Industry-Sponsored Clinical Trials: Impact on State Economies (2015)