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Development of a Patient Recruitment Program for Phase 2 Trials in a Biotechnology Company

Patient recruitment for clinical trials participation is an important component of clinical research. It has been reported that slow accrual to clinical trials not only increases the development time but is very costly. To improve the timeline for clinical development and assist with patient recruitment, Protein Design Labs, Inc., developed a proactive patient recruitment program. This program consists of three recruitment phases: recruitment phase 1 attempts to optimize the clinical protocols and identify appropriate clinical investigators and patients; recruitment phase 2 consists of outreach programs; and recruitment phase 3 provides site support materials, including approaches for patient retention. All aspects of the program are coordinated via a Protein Design Labs patient recruitment team that includes members from the clinical affairs, medical affairs, and marketing departments. A patient recruitment project manager is responsible for coordination of the programs and selected vendors. This article describes the Protein Design Labs program in detail.