How to streamline the translation of clinical trial summary reports?

1. What is a Clinical Trial Summary Report?

 

1-1. What is a clinical trial? What is the significance of expediting clinical trials?

Clinical trials are a type of clinical trial that is conducted on humans, and specifically refers to trials for the purpose of new drug approval, evaluating the effectiveness and safety of new drugs.
Clinical trials are conducted at the trial site based on strict protocols, with the pharmaceutical company as the trial requester and the appointed physician as the trial responsible physician. The results are then submitted to regulatory authorities in each country where the trial was conducted for review and approval.
When it comes to new drugs, the fate of clinical trials and approvals for obesity drugs and dementia treatment drugs has become not only medical news, but also economic news.
The impact of these new drug approvals on the medical community and patients goes without saying, but it also cannot be ignored that they also have an impact on the performance and stock prices of pharmaceutical companies, and thus our society and economy as a whole.
There have also been reports that the system of separately confirming the safety of Japanese people during the clinical trial process of overseas pharmaceuticals will be abolished (November 13, 2023). This can also be seen as a measure to promote the early introduction of new drugs.
There is great significance in expediting clinical trials.

1-2. What is the position of the clinical summary report in various clinical trial documents?

In clinical trials, various types of documents are generated.
These include the clinical trial implementation plan (protocol) which contains detailed information about the planning and execution of the trial, documents related to the drugs and products used in the trial which serve to deepen the understanding of the trial drug for the trial team and regulatory authorities, such as the Investigator's Brochure (IB), which outlines the risks, benefits, and details of the protocol, and documents such as the Informed Consent Form (ICF) which are provided to participants in the trial to ensure their understanding and consent to participate.

A Clinical Study Report (CSR) is a document that summarizes the results of a clinical trial. It is often referred to as "CSR" for short.
The CSR is created at the end of the clinical trial. Similar to the clinical trial protocol, it includes the purpose and plan of the trial, as well as statements related to GCP compliance and evaluations of safety and efficacy.
The CSR is submitted to regulatory authorities and is used to obtain approval for new drugs or treatments based on the results of the clinical trial. It is also shared widely with the medical community and researchers through publication in academic journals.

1-3. Composition of Clinical Trial Summary Report

"Guidelines for the Composition and Content of Clinical Trial Summary Reports" (Notification from the Director of the Pharmaceutical and Medical Devices Agency to the Directors of Prefectural Health Departments on May 1, 1996, No. 335) specifies the structure of the clinical trial summary report as follows, and provides detailed information on each item and sub-item in accordance with the guidelines.

1. Title Page
2. Overview
3. Table of Contents
4. List of Abbreviations and Definitions
5. Ethics
6. Investigator and Clinical Trial Management Organization
7. Introduction
8. Purpose of the Clinical Trial
9. Plan for the Clinical Trial
10. Patients Enrolled in the Clinical Trial
11. Evaluation of Efficacy
12. Evaluation of Safety
13. Discussion and Overall Conclusion
14. Tables, Figures, and Graphs to be Quoted but Not Included in the Main Text
15. List of References
16. Appendices

As such, it covers a wide range of content that encompasses the entire clinical trial.