Case Study - NERVOUS SYSTEM
BIPOLAR DISORDER – SITE SELECTION AND PATIENT RECRUITMENT AND RETENTION
Bright Pharmaceutical Services, Inc. was called upon to identify, vet and select investigative sites for a 45-site 650-patient phase III bipolar disorder trial in the US as well as run a broad reaching multi-language advertising and community outreach campaign. The study criteria were restrictive and there were multiple competing trials enrolling simultaneously which added to the challenge of the assignment. The goal was to not only identify investigators with experience as well as provide targeted patient recruitment and retention consultation and advertising campaigns.
Early in the process, the client began working with and establishing trust in the Bright team. The client relied on the team’s patient recruitment and retention experience, its access to a strong network of investigators who were engaged in Bipolar Disorder research as well as a proprietary database of hundreds of thousands of patients. For this trial, Bright created an aggressive patient recruitment plan for each of the 45 sites. The Bright team worked with each PI and their staff and took extraordinary steps to ensure the integrity of the research by developing a comprehensive training program that included ongoing site evaluations, webinars and newsletters and tailored scientific article discussions. Bright also sent country-specific communications to investigators, clinicians and patients to encourage retention. The advertising campaign consisted of print, radio and television advertising as well as a study website and a Call Center.
Recruitment was completed 3 months earlier than targeted and retention was 10% higher than goal. With this success, the client partnered with Bright on their entire program of bipolar trials in the US and their one ex-US trial.