The Evolving Role of the Community Pharmacist: An Opportunity to Bring the Study to the Patient

The Evolving Role of the Community Pharmacist: An Opportunity to Bring the Study to the Patient

Abstract Integrating community pharmacists into clinical trials offers a novel opportunity to enhance patient engagement, streamline data collection, and improve trial efficiency. By leveraging pharmacists’ accessibility and trust-based connections with patients, clinical trials can achieve higher recruitment, retention, and adherence rates. This approach streamlines the trial process, significantly reduces costs and site burden, and expedites…

“Diversity Now” Protocol – Powered by RxE2

Diversity Now, the first protocol to achieve diversity in clinical trials according to the FDA guidelines for Race and Ethnicity Diversity Plans This plan provides a pharmacist-centered approach for compliance with Section V Categories 4 and 5 of the US Food and Drug Administration’s industry guidance  (hereinafter “FDA Guidance”) for developing the required Race and…

State_Law_Position_Statement_RXE2

RxE2 State Law Position Statement

U.S. State Laws Govern the Dispensing, Labeling, and Counseling Requirements for Investigational New Drugs‍ When conducting clinical trials, sponsors have traditionally looked to 21 C.F.R. §312, and not state law, for guidance. Upon closer examination of state laws, however, it becomes clear that states throughout the country categorize Investigational New Drugs (“INDs”) as prescription drugs.…