BIMO Inspections: Recommendations for Sponsors

Clinical Researcher—June 2019 (Volume 33, Issue 6) PEER REVIEWED Mary Kay Kessinger Sobcinski, RN, BSN, MHA; Susan Wiskow, CCRP   The U.S. Food and Drug Administration’s (FDA’s) Bioresearch Monitoring (BIMO) program is designed to protect the rights, safety, and welfare of subjects, verify the accuracy and reliability of clinical study data, and assess study compliance […]

Accelerating Oncology Trial Recruitment by Identifying Patients at Diagnosis

Clinical Researcher—June 2019 (Volume 33, Issue 6) RECRUITMENT & RETENTION C. Meghann Howland; T.J. Bowen, PhD   Oncology researchers face a sizable patient recruitment challenge. The numbers alone paint a revealing picture: roughly 14,000 oncology trials are actively recruiting,{1} garnering participation rates estimated at a mere 3% to 8% of possible candidates, with even more […]