Read about the approach to drug development that includes tolerability, ease of use, compliance with therapy, and quality of life as topics addressed along with traditional quantitative risk-benefit analysis. The author speaks to the need for new and creative solutions that address the broader needs of patients as individuals.
CITI Program Courses for Those who Conduct Clinical Trials
Good Clinical Practice (GCP)
GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies.
Clinical Research Coordinator (CRC)
CRC courses focus on key topics essential to the conduct of clinical research. They are specifically tailored to the needs of clinical research coordinators.
Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov
This course provides a video-enhanced guide to compliance with the FDAAA Final Rule and NIH Policy on clinical trial disclosure in ClinicalTrials.gov.
Focuses on key topics essential to the biomedical investigator’s role and responsibilities in conducting a clinical investigation of a product regulated by the U.S. Food and Drug Administration (FDA). This role-based course covers supervision, delegation, management, reports, and communication for investigators.