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Evolution or Revolution? How Clinical Trial Recruitment Is Moving from Traditional Patient Referrals to Fully Consented Patient Enrollment

May 31, 2024
Evolution or Revolution?

How vital is clinical trial patient recruitment to the overall success of a clinical research study? Critical enough that an entire industry has emerged to expand clinical trial access and accelerate clinical trial enrollment for study sponsors and CROs. And while the majority of these providers follow a traditional recruitment model designed to deliver large numbers of pre-screened and partially qualified patient referrals to clinical trial sites, innovators such as Science 37 are fundamentally transforming the traditional model to produce even greater enrollment velocity by identifying, screening, and delivering fully qualified and consented patients. Understanding this important distinction holds the key to uncovering new clinical trial opportunities and overcoming today’s clinical trial participation challenges.

The Importance of Effective Clinical Trial Recruitment and Clinical Trial Enrollment

Meeting patient recruitment and enrollment goals is an essential part of any successful clinical trial. Without a sufficient number of patient referrals, trial sites cannot medically qualify and consent enough participants to conduct a valid study. This undermines their ability to establish a product's safety and efficacy in the eyes of the FDA and other regulatory bodies. If a sponsor underperforms in the recruiting and enrollment phase, the resulting delays can dramatically increase study costs and negatively affect time to market – a less than desirable outcome for everyone, especially patients in need of these important therapies.

In terms of magnitude, enrollment issues represent a massive threat to the development of effective new therapies. By some estimates, upwards of 50% of all trials experience costly delays as a result of patient recruitment challenges. Patient retention issues are a separate but related area of concern. Together, the struggle to find and keep patients enrolled in a study can add thousands, and in some cases even millions of dollars, to a study’s daily operating cost. 

As the average investment needed to recruit a single trial participant approaches $7,000, it makes perfect sense that trial sponsors and CROs are seeking out technology-enabled solutions to uncover new efficiencies. Whether that’s expanding access to reach new patient populations or using AI-powered targeting tools to optimize patient fit and reduce patient attrition post-enrollment, the time has arrived for a next-generation clinical trial patient recruitment strategy.

How are Patient Recruitment and Patient Enrollment Different?

In the traditional recruitment model, all activities leading up to the patient signing an informed consent form are considered part of the recruitment process. Potential participants are identified, engaged, and educated about the clinical trial. This pre-screening activity loosely establishes them as a “qualified” referral ready to be turned over to the nearest study trial site for enrollment – a more thorough medical qualification screening and consent process that is typically conducted in person by site staff. 

To accelerate the recruitment part of the process, study sponsors and CROs often employ outside resources to help augment their pool of patient referrals. Until recently, sponsors have struggled to reduce the time and resource burdens placed on site staff responsible for in-person enrollment activities. That’s no longer the case with the emergence of decentralized clinical trial providers who have taken the additional steps required to build out custom patient recruitment solutions. For instance, the groundbreaking methodologies developed by Science 37 leverage proprietary technology infrastructure and specially trained staff to combine the recruitment pre-screening and enrollment medical qualification and consent processes. As a result, Science 37 can deliver fully qualified and medically consented patient referrals that the industry would consider “first visit ready” for trial participation.  

The resulting blurring of lines between recruitment and enrollment represents one of the few tangible efficiencies with the potential to bend cost curves back in favor of study sponsors. 

A Patient-Centric Approach Can Maximize Participant Engagement and Retention

The use of digital tools to enhance the patient experience has allowed forward-thinking sponsors and CROs to prioritize participant engagement and retention in ways likely to improve the success of their research studies. 

By adopting a patient-centric approach throughout the entire patient journey, from initial recruitment through post-study follow-up, researchers can implement a set of clinical trial protocols that eliminate barriers to participation and help ensure study completion.

One of the most common causes of limited enrollment and poor patient retention is the distance a participant must travel to reach their trial site. To help reduce travel time and the inconvenience it brings, sponsors give careful consideration to the number and location of trial sites supporting the study. The rise of decentralized clinical trial platforms, such as the Science 37 MetasiteTM, have given researchers a powerful new tool for designing patient-centric protocols. In cases like the investigation of rare disease therapies, Virtual Site capabilities can expand study access to diverse new patient populations. Enhanced reach makes these particularly difficult-to-enroll studies more cost-efficient while producing higher-quality data.

Advocating for Diversity and Inclusion to Improve Clinical Trial Access

FDA-issued guidance for increasing diversity in clinical trials has prompted the clinical research industry to take a closer look at its recruitment efforts. As regulatory compliance and reporting requirements such as the ones included in the DEPICT Act continue to play a larger role in clinical studies, the ability to access suitably diverse patient populations becomes vital to study success.

Barriers such as lack of awareness about clinical trials, language barriers, transportation issues, cultural mistrust, and limited access to healthcare facilities often hinder recruitment in underrepresented populations. Overcoming these barriers requires targeted outreach efforts and tailored strategies to engage and educate potential participants.

Ultimately, the quality of a study’s research data will be compromised unless the population of trial participants is properly representative of the patient population intended to benefit from the therapy or medical device. By actively addressing this inclusivity challenge head-on during the recruitment and enrollment process, sponsors have the opportunity to ensure the clinical trial participation of underserved groups critical to a study’s outcome. Accessing these underserved groups, however, can be tricky. When combined with a Virtual Site capability to eliminate the geographic barriers to participation, advanced targeting and screening tools like those employed by Science 37’s Patient Recruitment Solution provide study teams with an integrated recruitment strategy – one that’s sufficiently diverse in terms of race, ethnicity, age, and gender, while also streamlined and cost-effective.

The Future is Now: First-Visit-Ready Clinical Trial Recruitment

The advent of digital marketing revolutionized clinical recruitment outreach by allowing researchers to tap into vast social networks to find potential participants more quickly and inexpensively. Today, recruiters have access to electronic health records and a wide range of digital platforms that can help them identify and recruit potential patients who satisfy the inclusion criteria for their clinical trial. Some researchers have even developed their own patient identification apps in an effort to gain a recruiting and enrollment advantage. In other words, the sophistication of Patient Recruitment activities is constantly adapting to meet emerging challenges.

But where is Patient Recruitment headed next? Actually, the transformation has already begun. In contrast to the traditional patient recruitment model, where loosely qualified patient referrals are handed off to resource-constrained site staff for medical qualification and informed consent, the next generation of Patient Recruitment is utilizing technology-enabled processes and specially trained staff to deliver fully qualified and consented patients who are first-visit ready. Clinical research sponsors who use this new approach to augment their recruitment activities are reporting higher-quality patient referrals and compressed timelines to achieve full enrollment. By accelerating research in the enrollment phase, providers such as Science 37 make it possible to meaningfully reduce a therapy’s time to market.

Defining Success in Clinical Trial Enrollment 

Patient recruitment for clinical trials is both a threat and an opportunity for today’s clinical researchers. Study sponsors and CROs who fail to leverage the latest available tools will find themselves at greater risk in terms of costs and time delays to achieving full enrollment. Those who embrace innovative technologies and expert-driven processes will experience the benefits of shorter timelines to full enrollment, more streamlined and patient-centric engagement, and higher quality data produced by representatively diverse patient populations.  

The current revolution in patient recruitment is bringing more effective therapies to the patients who need them, and doing it faster. Maximizing your success as a clinical researcher means recognizing this opportunity and taking advantage.