Clinical research: ASHP guidelines and future directions for pharmacists

Area of Science:

• Pharmaceutical Sciences
• Clinical Research
• Health-System Pharmacy Practice

Background:

• The American Society of Health-System Pharmacists (ASHP) has established guidelines for pharmacists' involvement in clinical drug research.
• Previous guidelines from 1990 have been updated to reflect current practices and challenges in the field.
• The evolving landscape of clinical research necessitates updated standards for pharmacist participation.

Purpose of the Study:

• To describe the ASHP guidelines on the pharmacist's role in clinical drug research.
• To outline future directions for pharmacists within clinical drug research.
• To emphasize the responsibilities of health-system pharmacists in ensuring sound research systems and patient protection.

Main Methods:

• Review and update of existing ASHP guidelines on investigational drugs.
• Inclusion of expanded focus areas such as business practices, technology implications, and research beyond academic centers.
• Definition of minimum standards for pharmacists involved in clinical research.

Main Results:

• ASHP Guidelines on Clinical Drug Research approved in November 1997 provide updated standards.
• Minimum responsibilities for pharmacists include drug accountability, patient information provision, and ensuring patient care.
• Management and coordination of clinical drug research are identified as growth areas for pharmacists.

Conclusions:

• Pharmacists are essential for ensuring the safety, effectiveness, and integrity of clinical drug research.
• Adherence to ASHP guidelines helps improve performance and protect patients.
• Pharmacists can enhance data accuracy, completeness, and patient safety through pharmaceutical services in clinical research.