A biopharmaceutical company sponsoring a Phase III clinical trial in the United States.
The trial required the recruitment of patients with a neurological pain indication. The sponsor perceived a potential concern that patients had several alternative treatment options, including commercially available products, and therefore, may not be interested in a clinical study opportunity for this condition. The trial also experienced many screening failures due to inclusion and exclusion criteria not sufficiently identified in their current referral process.
The sponsor added E2 Recruitment services late in the study for additional recruitment support for sites and to meet milestone timelines. The service included identifying pharmacies and patients near current clinical sites, pharmacist-driven interviews of patients using an Institutional Review Board (IRB)-approved questionnaire to refine eligibility of medical and prescription history, and pharmacist referral of qualified patients for formal screening.
Over four months, 104 pharmacies serving 15 clinical sites identified hundreds of potential patients for the trial opportunity. In summary, 398 patients were contacted for an interview, 50 patients met the eligibility criteria, and were referred to the clinical site. Of those patients who completed screening at the clinical site, 14% were randomized into the study.
“As they were talking to me…. you could see their hesitancy, and anxiety about this opportunity melting away. I was pleasantly surprised to see the impact that I had on these people’s lives and their overall health.”
“[Indication] are on my top-five list of afflictions that evoke the most empathy from me. I just completed my first interview and the patient qualified as a referable candidate. I can’t describe how awesome it feels to potentially help in this way.”
“The amount of referrals that turned into screens is better than any other vendor we’ve had. RxE2 was a fantastic idea!”
With this trial’s addition of E2 Recruitment services, clinical trial sites were supported with a new referral source and received vetted, qualified referrals from a local healthcare provider. Eighty-six percent (86%) of patients engaged with the pharmacist when contacted about the opportunity and, because of their trusted relationship, were open to learning more, completed an interview, and agreed to the referral if eligible.