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Client

A biopharmaceutical company sponsoring a Phase III clinical trial in the United States.

Challenge

The trial required 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 was also experiencing a high number of screen failures due to inclusion and exclusion criteria that were not being sufficiently identified in their current referral process.

Solution

The sponsor added E2 Recruitment services late in the study for additional recruitment support for sites and to meet milestone timelines.  The service included identification of pharmacies and patients located near current clinical sites, pharmacist driven interviews of patients using an IRB-approved questionnaire to refine eligibility through review of medical and prescription history, and referral of qualified patients by pharmacists directly to the sites for formal screening.

Results

Over 4 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, following the interview, 50 patients met the criteria for referral eligibility and were referred to the clinical site, and of the patients who completed screening at the clinical site, 14% were randomized into the study.

Testimonials

Pahrmacists

“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.”

Site

“The amount of referrals that turned into screens is better than any other vendor we’ve had. RxE2 was a fantastic idea!”

Conclusion

With the addition of the E2 Recruitment service to this trial, the sites were supported with a new referral source and received vetted, qualified referrals from a local health care provider. Eighty-six (86) percent of patients engaged with the pharmacist when contacted about the trial opportunity and, because of their trusted relationship, were open to learning more, completing an interview, and agreed to the referral if eligible.