The new article describes in detail the key responsibilities of the parties involved in clinical research.
Table of content
The Drug Regulatory Authority of Pakistan (DRAP), the country’s agency in healthcare products, has published a guidance document dedicated to clinical research.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance with them.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
Moreover, the authority reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In particular, the guidelines address the aspects related to the responsibilities of the parties involved in clinical research.
The appropriate section on the requirements and critical responsibilities for conducting clinical trials or BA/BE (Bioavailability/Bioequivalence) studies in Pakistan, as outlined in the Bio-Study Rules of 2017, offers a structured framework to ensure the ethical, scientific, and regulatory integrity of clinical research within the country.
The document describes in detail the prerequisites for initiating such studies, the roles and responsibilities of various stakeholders, and the operational and ethical guidelines that govern clinical research in Pakistan.
Prerequisites for Conducting Clinical Trials or BA/BE Studies
By the applicable regulatory requirements, to commence clinical trials or BA/BE studies in Pakistan, several critical conditions must be met:
- The trial site or study center must be licensed by the Clinical Studies Committee (CSC) of the Drug Regulatory Authority of Pakistan.
- The Institutional Review Board (IRB) and National Bioethics Committee (NBC) must have granted a favorable opinion on the trial/study.
- The Clinical Studies Committee of the DRAP must have approved or registered the trial/study.
These prerequisites ensure that all clinical research is under stringent regulatory oversight, emphasizing safety, ethical standards, and scientific validity.
Roles and Responsibilities
The document further provides additional explanations and clarifications regarding the roles and responsibilities of all the parties involved in clinical investigations conducted in the country.
As the national regulatory body, the Drug Regulatory Authority of Pakistan (DRAP)
oversees the safety, quality, efficacy, handling, and use of investigational products. It mandates that any clinical research involving therapeutic goods must have a registration certificate and/or a site/center license.
National Bioethics Committee (NBC)
The NBC is responsible for ethically overseeing all clinical research in Pakistan. Obtaining NBC’s approval is mandatory before submitting a clinical research application to DRAP, ensuring that all research adheres to the highest ethical standards.
Institutional Review Boards (IRB)
According to the guidelines, IRBs within public or private health institutions are responsible for the ethical clearance and periodic review of clinical research.
They play a critical role in maintaining the ethical integrity of the research and reporting their findings to the CSC.
Sponsor
The sponsor assumes responsibility for the initiation, management, and/or financing of the clinical research.
They may delegate tasks but retain ultimate responsibility for the trial’s conduct and compliance with regulatory requirements and ICH-GCP guidelines.
Principal Investigator (PI)
The PI is the lead researcher responsible for the overall conduct of the study, including participant safety, data integrity, and compliance with legal and regulatory requirements. They ensure the study’s ethical execution and scientific validity.
Co-Principal Investigator(s) (Co-PI)
The Co-PI shares scientific and administrative leadership with the PI, ensuring collaborative oversight and clinical trial/study management.
Site Investigator(s)
Site Investigators, or Site PIs, are primarily responsible for conducting the study at their respective sites under the leadership of the PI, ensuring localized oversight and management.
National Pharmaceutical Association
Representatives from the Pakistan Pharmaceutical Manufacturers Association and the Pharma Bureau participate as observers in the CSC, providing industry insights and suggestions to enhance research culture and development in Pakistan.
Their role is merely advisory in its nature, focusing on the progression of a supportive research environment.
Observers in the Committee
Observers attend CSC meetings to listen and, with permission, share observations. They are expected to maintain confidentiality regarding meeting content but may submit written suggestions to the CSC chairman to foster research development and streamline processes in Pakistan.
Conclusion
In summary, the present draft guidelines describe in detail the existing comprehensive framework of requirements and responsibilities representing a robust system designed to ensure that clinical trials and BA/BE studies in Pakistan are conducted according to international standards of safety, efficacy, and ethics. By outlining the roles of key stakeholders, from regulatory bodies to individual researchers, the authority aims to create a conducive environment for clinical research that prioritizes participants’ welfare, scientific integrity and reliability of the investigation results, and regulatory compliance.
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