While serving as a principal investigator (PI) for ObvioHealth, a digital clinical research organization (CRO), I’ve had the pleasure of overseeing clinical trials designed to operate in the digital “hybrid” and “virtual site” setting. Thus, I’ve found that the traditional site setting can make patient recruitment a difficult task to manage. In a world where 85 percent of all clinical trials fail to reach the enrollment target, it might be worth analyzing an alternate approach to the traditional recruitment conundrum.
Pre-Enrollment: Coupling Social Media Recruitment with Patient Centric Trials
Digital patient-centric clinical trials (PCT) are often carried out in the hybrid setting (minimizing site visits and maximizing the use of a virtual site), or the site-less setting (solely using the virtual site). The pairing of a digitalized PCT with social media targeting increases the probability of successful enrollment.
In a recent double-blind randomized placebo-controlled study managed by our team, we paired social media recruitment with a hybrid digital clinical trial model and were tasked with analyzing a dietary supplement as an intervention for adults with an elevated blood pressure or stage I hypertension. Recruitment needs called for the enrollment of 128 adults, 30-65 years of age, with a blood pressure of 120-139/80-89 mmHg, and not being treated with medications for blood pressure. Potential participants were required to be living within the vicinity of Houston, TX, and Atlanta, GA – the two sites utilized for physical assessments/labs. Targeting via social media allowed for the inclusion of a diverse patient population, as diversity and gender goals called for the following enrollment targets: White/Caucasian (60-70 %), Black/African-American (10-30%), other race (10-20%), male and female (50% ±10%). Inclusionary/exclusionary criteria were followed closely when identifying potential participants.
After targeting, interested subjects were directed to an online prescreening questionnaire; if aligned with the initial entry criteria – subjects were then invited to access ClaimIt™ (ObvioHealth’s proprietary application used to conduct digital clinical trials). Through the app, patients were provided the opportunity to fill out remaining screening forms, and schedule an appointment to complete physical screening assessments at a physical site.
It’s important, as a PI, to point out the utility of ClaimIt™ during the pre-enrollment process. In the traditional “brick and mortar” model, subjects must sit down with a member of the study team to review the informed consent form page-by-page and be provided the opportunity to ask questions before deciding to consent. ClaimIt™ offered an electronic informed consent form, affording participants the time to review each page on their own accord, while still being able to communicate (virtually via ClaimIt™) with a member of the study team. In turn, this not only saved time/resources on part of the study team, but the participant as well – doing away with the need for a site visit for the review/signing of the ICF and completion of pre-screening/screening questionnaire assessments. Having the capability to communicate virtually with the study team allowed for enhanced patient engagement, and encouraged a comprehensive understanding of the study and its requirements.
Widening the “Participant Pool”
In the traditional “brick and mortar” setting, recruitment efforts heavily rely upon the aid of doctor’s offices. A member of the study team may visit numerous locations in hopes that each doctor may have qualified patients in mind who would show interest in the study. This approach limits the study team to participants recommended by a doctor.
By using social-media as our sole source of recruitment, we were instead able to target and enroll a diverse participant population–who met the extensive inclusion/exclusion criteria – as evidenced by the following post-enrollment breakdown: White/Caucasian (48%), Black/African-American (41%), and other race (11%); patients were 58 % female, and 42% male. In this way, we managed to successfully enroll a diverse array of participants within the designated geographic locations without having to rely on referrals from a doctor.
Written by Parth Shah, M.D. : Senior Director of Medicine and Economics
Parth is a physician scientist with diverse clinical and research experience. He is an expert in cardio-metabolic and endocrine diseases and is passionate about improving patient care via advancements in research. Dr. Shah serves as an investigator in sponsored and investigator initiated studies. He has great experience in all phases of clinical trials from planning and development to its execution. Dr. Shah is skilled at providing medical input to cross functional teams such as clinical operations, IT, business development, biostatistics, pharmacovigilance, etc.
Dr. Shah has published many manuscripts in credible, peer-reviewed medical journals and presented research at prestigious medical conferences.
He earned a Bachelor of Science from Youngstown State University, Doctor of Medicine from Washington University of Health and Science, and served as a clinical fellow/researcher at Mercy Health/Jewish Hospital.