The global health ecosystem relies heavily on clinical research. The public is increasingly dependent on advances in research to fuel the development of new and old treatments for diseases. Moreover, the current pandemic has emphasized the importance of speed in clinical trials. Despite significant advancements in the field in recent years, there is still a lot of room to improve the efficiency of clinical trials to reduce costs and shorten study timelines.
Although significant resources are being devoted to clinical trial innovation, patient recruitment and enrollment remain the primary cause of clinical development delays. The US pharmaceutical research budget (approximately $7 billion) dedicates around 40% to clinical trials, while 40% of that is spent on clinical trial recruitment (approximately
$2 billion).
The eye-popping statistics say that 80% of clinical trials do not meet their enrollment deadline, while 50% are terminated due to an insufficient number of study participants. Add to that 20% of participants who withdraw from the trial after a certain period. Another devastating fact is that only 10% of all clinical trial patients come from minority groups.
After decades and tens of billions of dollars, the industry has worked to combat these problems. Sponsors of pharmaceutical products have committed more resources to recruitment strategies that aim to reach more patients by casting wider nets or utilizing social, behavioral, and demographic data. Many companies engage potential patients and refer them to nearby sites using sophisticated algorithms. These solutions solve only parts of this problem, but the industry must do more to enroll most trials rapidly and predictably.
This implies that traditional enrollment and recruitment strategies are not so efficient.
Despite innovations and advances in clinical technology, the overall enrollment campaigns are designed to funnel large numbers of candidates. As a result, this scattershot approach wastes both time and budget on vetting patients and brings in many ineligible candidates.
Inefficient Traditional Methods of Recruiting Participants
A substantial number of participants in clinical trials typically come from a pool of patients who have previously interacted with sites for other trials or routine medical care and who reside near clinical trial sites. These candidates often turn up through the sites’ own systems, charts, and patient records. In an effort to find patients who may meet eligibility criteria, site teams are overburdened since sponsors tend to re-use the same study sites frequently.
However, relying on the same patient demographics results in a homogeneous patient population that does not represent the real-world population. Only those patients who live approximately an hour or two away from the site can potentially bring accurate results and should be considered for research participation.
Another major problem with patient recruitment is that most clinical trial sites are located in more affluent metropolitan areas, so the patient populations tend to be predominantly white and affluent. This implies that large groups of people and minority populations have no access to these clinical trials, although they might be eligible to partake. The statistics say that 83% of the clinical trial participants are whites, 5% African American, and 1% Latino.
Moreover, it is estimated that over 90% of prospective participants do not enroll in the clinical trials. Oftentimes, patients who drop out are exempt from participation due to legitimate reasons, such as drug allergy or comorbidity. However, the data show that many of them would be eligible to enroll in studies but are lost due to inefficiencies in managing trials. As a result, there are substantial amounts of “avoidable losses” encountered during the recruitment and enrollment of patients that, if addressed, can have a significant impact on the success of the trial.
New Approach to Transform Patient Recruitment
Sites and sponsors benefit from improving recruitment and enrollment at the top of the funnel by identifying potential patients early on, creating visibility for all parties involved, and reaching enrollment goals for clinical trials efficiently and successfully.
The clinical trial process is the center of therapeutic innovation and discovery, yet it lags in terms of digital transformation. Technology-driven solutions can enable patient-centered approaches to clinical trial recruitment and help transform the enrollment process. Utilizing all the information available to understand patients better is the first step toward a patient-centric recruitment program.
Identifying an ideal clinical trial participant can be achieved through cloud-based databases. This provides insight for sites, sponsors, and partners into what works and what doesn’t work. Combining patient data from electronic health record databases with consumer data allows for highly accurate patient profiling using modern data science to target quality candidates.
Health records benefit in a way that provides information on where patients are located, where they receive care and whether any of them meet trial eligibility requirements. On the other hand, consumer data provides information about the demographics of patients, where they go online to learn about their health conditions or connect with other people.
Upon gathering patient profiles, study leaders can develop tailored messages resonating with potential candidates and deliver those messages via the online channels those candidates prefer. This way, study leaders can identify eligible participants and patients who meet inclusivity and diversity goals.
This data-driven messaging will significantly reduce the number of ineligible candidates, reducing the time and effort that study teams are required to spend vetting and eliminating them.
Available technology also eases the process of getting to those patients who are less tech-savvy or more difficult to reach through advertising or social media. This way, clinicians can be notified any time there is an eligible clinical trial candidate.
Many potentially eligible candidates drop out of the recruitment process simply because it is time-consuming. Fortunately, technology can also facilitate the patients’ journey through the enrollment process. With the use of recruitment technology platforms, patients are guided along the path to enrollment quickly and easily.
One example of how it might look includes eligible candidates brought in through suitable advertising campaigns and data-driven messaging. Clicking on a specific URL they have received; they are led to a dedicated landing page to fill in a self-screening questionnaire.
The clinical study team gets in touch with those candidates who pass the questionnaire. After a team member confirms the patient’s eligibility, an in-person appointment is set up to complete the enrollment process. As a result, the team can reach out to potential participants who meet eligibility and demographic criteria.
Conclusion
Modern recruitment technology brings the clinical trial enrollment and recruitment process to another level. Instead of bringing in a large number of potential candidates, this approach enables the study teams to target patients from various sources and have complete control over the entire enrollment process. This transparency is more than necessary since it helps them to quickly make changes to those recruitment methods
that don’t work.
Moreover, data-driven new technologies accelerate the patient vetting process and minimize the loss of quality candidates. Therefore, sites and sponsors can dedicate more time to interacting with candidates most suitable for clinical trials.
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