International Journal of Pharmacology and Clinical Sciences, 2022, 11, 1, 03-08.
DOI: 10.5530/ijpcs.2022.11.2
Published: April 2022
Type: Review Article
Authors: Yousef Ahmed Alomi, Amal Hassan Al-Najjar, Hamidah Qasim Ali Abushomi, Maha
HusseinAlmadany, and Abeer Hussin Almasoudi
Author(s) affiliations:
Yousef Ahmed Alomi*, BSc. Pharm, MSc. Clin Pharm, BCPS, BCNSP, DiBA, CDE, Critical Care Clinical Pharmacists, TPN Clinical Pharmacist, Freelancer Business Planner, Content Editor, and Data Analyst, Riyadh, Saudi Arabia.
Amal Hassan Al-Najjar, BSc, MSc, Drug and Poison Information Center, Security Forces Hospitals, Riyadh, Saudi Arabia.
Hamidah Qasim Ali Abushomi, BSc, MSc. Clin Pharm Dammam Medical Complex, Dammam, Saudi Arabia.
Maha HusseinAlmadany, BSc, Pharm, Health Care Quality Management Professional Diploma (HCQM), Pharmacy Quality Department, King Salman bin Abdulaziz Medical City, Al Madina Al Monwarah, Saudi Arabia.
Abeer Hussin Almasoudi, BSc. Pharm, Director, Administration of Research and Studies, Ministry of Health, Tabuk, Saudi Arabia.
Abstract
Objectives: This study aims to explore the research policy of investigational drugs in the clinical trial as a new initiative in Saudi Arabia. Methods: This article is a narrative review of pharmacy research. Literature researched specific research policies and procedures in pharmacy practice using a variety of databases, including PubMed, Medline, and Google Scholar. The period covered for the search is from the 1960s to October 2021. The terms used are in the English language and encompass narrative reviews, systemic reviews, meta-analyses, and guidelines. The search term encompasses all hospital and community pharmacy-related services. Besides, there are national and international guidelines for conducting general research in hospital practice. The pharmacy research committee was formed and comprised numerous expert members, including clinical pharmacists, pharmacists specializing in drug information, and clinical research specialists. A member drafted the policy’s guidelines, which were then reviewed and corrected by another member. The research specialist made the third revision. The subject emphasizes the research policy for investigational drugs in the clinical trial. Results: A general policy was established for investigational drugs in clinical trials, which included defining clinical trials and addressing related issues. Clinical trial approval policy, the role of the Institutional Review Board, the clinical responsibilities of the research team, and patient informed consent. Apart from that, clinical trials require patient records and auditing. Conclusion: The research policy for investigational drugs in a clinical trial is a novel initiative within pharmaceutical care research and development. The research policy for investigational drug in clinical trials protects patient rights and safety. Additionally, encourage pharmacy services to implement and conduct clinical trials in pharmacy practice at healthcare institutions of Saudi Arabia.
Keywords: Clinical trial, Drug, Investigational, Policy, Research, Saudi Arabia