Centralized Patient Recruitment: A More Effective Tool
For decades, patient recruitment has remained one of the largest pain points in clinical trials. The issue is so persistent, that the stats have almost become a mantra: 80% of trials fail to meet their enrollment timelines, 50% of sites don’t meet their enrollment targets, and 40% of clinical trial delays are associated with recruitment issues. Despite these persistent challenges, the inertia in clinical research has resulted in mostly the same approach to recruitment: activate sites and hope they have the tools to bring in the patients. Unfortunately, that’s not working as 30% of sites under enroll and 11% of sites fail to bring in a single patient.
Because of these challenges, more and more, sponsors and CROs are leveraging centralized recruitment solutions. The basic mechanism of centralized recruitment is: through a variety of channels, a centralized recruiter (a 3rd party vendor) finds patients and directs them to all or many sites in a trial. The scale benefits of this approach can be significant, and sponsors have a higher level of visibility into the pace of their recruitment as well as what messaging is drawing in patients.
But with more and more vendors in the market, how do you choose the right one? While the decision will vary based on trial design, therapeutic area, and geography, a few factors should always be considered when choosing a central patient recruitment vendor.
#1: How does the recruiter find patients?
Central patient recruiters tout many different methods of finding more patients for a trial. Some will tap into EHR data; others will do community engagement; but more and more, the key is digital advertising. While the advertising market is constantly shifting, targeted advertising to potential patients is a highly effective tool to fill the top of the patient recruitment funnel. Directly engaging patients through advertising has the benefit of active participation by potential patients. They have clicked on an ad; they have filled out an online screening form; they have recently expressed interest in clinical research.
EHR scanning and outreach can find good referrals, but those patients have yet to raise their hand and express interest, or they did so long before the recruiter reached out, and that patient’s circumstances may have changed. Community engagement finds highly engaged patients, but this is challenging blocking and tackling work; the ability to scale is limited and the ROI is often low.
Digital advertising, on the other hand, has a scale and impact benefit that outweighs most other methods of centralized patient recruitment. It can find enough patients to move the needle at most sites, it can find those patients at a relatively low cost per referral, and the patients being sent to those sites have already actively engaged in the trial process. Other methods can be leveraged, but digital advertising at scale should be a core part of the playbook.
#2: Does the recruiter engage all stakeholders?
Centralized patient recruitment almost always requires technology, but the service component cannot be overlooked. Many centralized patient recruitment vendors are trying to solve the challenges of patient recruitment through a combination of technology and data to send each site the perfect patient who will always randomize. The human element of all stakeholders–sponsors, CROs, sites, and patients–is put to the side in this approach. A centralized patient recruiter needs to be able to engage all of these stakeholders at a human level. If your patient recruitment vendor does not have specific teams managing and advocating for each of these stakeholders, the human elements will defeat the best laid plans.
The reasons a qualified patient does not randomize into a trial are inherently human. Sites may not engage the patient fast enough; the CRO / sponsor’s protocol might be overly burdensome; or the patient just might not understand the trial. Recruitment personnel must be ready to engage each of these stakeholders to identify challenges and resolve them. This work can be enabled by technology, but when a patient is being asked to partake in clinical research, humans must be involved in guiding them through the process.
#3: Does the recruiter know their patient funnel?
Patient recruitment vendors will often advertise their cost per randomization, but ask them to show their work and you will hear crickets. A price per randomization is the overall metric, but how many potential patients will they have to engage? How many of those potential patients will pass the online screener? How many of those qualified patients will visit the site and consent to the trial? A tech-enabled patient recruiter should be able to walk a CRO or sponsor through data-supported estimates for each one of these steps.
Furthermore, that recruiter should be ready to provide performance metrics during recruitment for every step of the process. Over or under performance throughout this process at each step determines whether recruitment will be completed on time and on budget. A sponsor and/or their CRO should expect regular updates and corrective action plans for deviations from plan. If this funnel is not being constantly monitored, and the recruiter is not willing to share that performance, chances are the promised results are not going to be delivered.
Conclusion
Centralized patient recruitment is becoming a more common tool to fill enrollment on time and on budget. A line item for it in a study budget can help save the overall budget for a clinical trial, but with any new line item in the budget, the factors in choosing a vendor have to be closely considered. Choosing a vendor that has an effective method to engage patients, can guide all stakeholders to a randomization, and is ready to show the supporting data behind their work from start to finish are all factors that should be considered when choosing a centralized patient recruiter.