TY - JOUR T1 - Research Policy of the Investigational Drugs in the Clinical Trial JF - International Journal of Pharmacology and Clinical Sciences Y1 - 2022 A1 - Yousef Ahmed Alomi A1 - Amal Hassan Al-Najjar A1 - Hamidah Qasim Ali Abushomi A1 - Maha HusseinAlmadany A1 - Abeer Hussin Almasoudi KW - Clinical trial KW - Drug KW - Investigational KW - Policy KW - Research KW - Saudi Arabia AB -

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. Litterateur 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 encompasses 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.

VL - 11 IS - 1 ER -