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The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to clinical trials. The document provides an overview of the applicable regulatory requirements and also highlights the key points to be considered by medical device manufacturers and other parties involved in operations with medical devices to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, and should not be construed as the ones introducing new rules or imposing new requirements. The authority also reserves the right to amend the recommendations provided, should it be reasonably necessary to reflect the respective changes to the underlying legislation. 

Clinical Trial Registry 

The scope of the guidance covers, inter alia, the aspects related to the clinical trial registry – an official catalog, containing a publicly accessible record of approved clinical trials. The said catalog is maintained by the authority to ensure that all the important information about clinical trials is duly kept and available for the parties involved. The guidance further outlines the scope of information to be included in the said registry. As explained by the authority, the trial-related entry in the registry will contain such details as: 

• A summary of a trial;
• Information on trial design, including such aspects as allocation, intervention mode, assignment masking, and primary purpose;
• Medical condition;
• Healthcare products are subject to investigation in the course of a trial;
• The date when the trial has been approved, as well as its duration;
• Current status and phase of a trial;
• Subject enrolment process and eligibility criteria used;
• Healthcare facilities participating in a trial;
• Information about the parties involved, including study sponsor, funder, coordinator, and investigator;
• The date of the last update. 

The authority also mentions that the country’s national register is expected to be linked to the respective international network of registers at some point in the future. The DRAP additionally emphasizes that in any case, all the information contained therein would be available to the interested parties. 

It is also important to mention that the authority recognizes the U.S. National Trial Registry. Hence, all the parties involved may submit information to this registry as well. 

The document also provides information about the trial subject registry – a verifiable record of the clinical trial participants or subjects to be maintained to stop duplicate enrolment and also to improve both patient safety and preserve data integrity of clinical trials. It is important to mention that to ensure personal data protection, information about study participants should be communicated directly to the DRAP. 

Investigator’s Brochure 

The scope of the guidance also describes the approach to be applied concerning the Investigator’s Brochure (IB), which is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. The said document is intended to provide the investigators and other parties involved in a study with sufficient information about the trial they may need. The Investigator’s Brochure should contain all the important information about the trial, the product subject to investigation, and the methods used. The scope of the document also covers the aspects related to the clinical decision-making process related to the trial. According to the guidance, the information should be presented in a concise, simple, objective, balanced, and no promotional form that enables a clinician, or potential investigator, to understand it and make his/her unbiased risk-benefit assessment of the appropriateness of the proposed trial. To ensure this, persons with medical backgrounds should be involved in drafting the aforementioned document. 

The guidance further outlines the scope of information to be included in the Investigator’s Brochure (IB) and explains how it should be provided. The authority also mentions that in case the product subject to investigation is already available on the market, and there is sufficient information regarding its safety and performance, the IB is not required to be so extensive. At the same time, should the product in question be investigated concerning new use, and such use should be described in detail? To ensure the information contained in the IB is relevant and up-to-date, the document should be subject to review at least once a year. Depending on the information which becomes available in the course of a trial, more frequent reviews could be required. The authority also mentions that in certain cases, new information could be so important that it should be communicated to all the parties involved without further delays, i.e., even before the next revision. Under the general rule, the study sponsor is the one responsible for ensuring that the IB contains all the necessary information about the trial and that all the information provided therein is relevant, accurate, and up-to-date. 

According to the guidance, the IB should contain the following elements:

1. The title page provides information about the study sponsor and the product in question. This page should also provide information about the IB itself, including the edition number, release date, and reference to the previous version replaced by the current one. 
2. Confidentiality statement confirming that the IB is confidential and should be used only in the context of a specific trial. 
3. Table of contents, summary, and introduction. 
4. Physical, chemical, and pharmaceutical properties and formulation – the section which provides detailed information about the product in question and its properties. 
5. Information about any non-clinical studies the product was subject to before the commencement of a clinical trial. 
6. For medicinal products – non-clinical pharmacology, pharmacokinetics, and product metabolism in animals. 
7. Details about the factors related to toxicology and its effects in humans. 

In summary, the present DRAP guidance provides an overview of the applicable regulatory requirements in the sphere of clinical trials. The document explains specific aspects related to the clinical trial registries, and also describes in detail the matters to be considered concerning the Investigator’s Brochure to be issued by a party responsible for the trial to properly communicate all the important information related to the trial. 

Sources:

https://www.dra.gov.pk/wp-content/uploads/2022/05/Guidelines-on-Clinical-Trial-Applications-For-Applicants.pdf 

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