Proposed new regulations on clinical drug trials

Ministry of Health proposes new regulations on clinical drug trials

Clinical drug trials are scientific activities that study drugs on human volunteers to explore or determine the safety and effectiveness of drugs; identify and detect adverse reactions caused by drug effects; and the ability to absorb, distribute, metabolize, and excrete drugs.

Principles of Good Clinical Practice

- Principle 1: Clinical trials must be conducted according to the basic principles of biomedical research ethics in the Declaration of Helsinki, first adopted by the World Medical Association (WMA) in 1964 in Helsinki (Finland) and periodically updated.

- Principle 2: The benefits and risks or inconveniences to clinical trial participants, to society or the community must be fully and carefully considered before starting a clinical trial on the basis of ensuring the safety, health and rights of clinical trial participants.

- Principle 3: Clinical trials should only be initiated if the anticipated benefits to clinical trial participants and to society outweigh the potential risks. Scientific and social benefits must be fully and carefully considered and considered on the basis of ensuring the safety, health and rights of clinical trial participants.

- Principle 4: Clinical drug trials must be conducted on the basis of strict compliance with the research protocol and process approved by the Ethics Council, the Scientific Council and the competent management agency. Any changes in the research protocol and process must be promptly reported and fully approved by the competent agency or organization.

- Principle 5: The review of clinical drug trials must be comprehensive and thorough, based on full information on preclinical, clinical and other previous research results related to the drug (if any).

- Principle 6: Participants in clinical drug trials are guaranteed the following rights: to provide full relevant information according to Form No. 09 in Appendix III issued with this Circular; to request further explanation and clarification of information related to the research when necessary; to respect the cultural characteristics and customs of individuals, regions, and ethnic groups and to decide whether or not to participate in clinical drug trials; to provide free medical services in an appropriate manner; research participants who are under the age of majority, have limited civil act capacity or have lost civil act capacity must have the consent of their representative according to the provisions of law on participation in clinical drug trials.

- Principle 7: The clinical trial facility is responsible for arranging for appropriately qualified physicians to provide medical care and make medical decisions for clinical trial participants when necessary and in accordance with the provisions of law.

- Principle 8: Each individual participating in the conduct of clinical trials must ensure the standards of professional qualifications, training, education and experience to perform their respective tasks in clinical trials.

- Principle 9: All information about clinical trials must be recorded, processed, managed and stored in accordance with regulations to be able to accurately report, explain, monitor and check the accuracy and reliability of information and data about clinical trials.

- Principle 10: Records used to identify clinical trial participants must be protected and maintained to ensure their right to privacy in accordance with legal requirements.

- Principle 11: Reagents must be manufactured, managed and stored in accordance with relevant good practice guidelines and used only for research in accordance with the approved research protocol.

- Principle 12: The quality assurance system and methods for ensuring quality in clinical trials must be fully and accurately implemented in accordance with the quality assurance provisions in this guideline and the legal provisions on quality assurance of drugs used in research.

- Principle 13: Respect the culture, identity, traditions and customs of the community where clinical trials are conducted.

Implement clinical drug trials

According to the draft, clinical drug trials are only allowed to be implemented when approved by a competent regulatory agency.

The implementation of research on drug trial participants may only begin after information about the research has been fully communicated to the drug trial participants and the drug trial participants or their legal representatives have signed the Research Information Form and the Research Voluntary Participation Form.

The research team and clinical trial facility are responsible for organizing and implementing the research in accordance with the approved research protocol and research process.

Essential documents before conducting, during implementation and after completion of clinical drug trials according to Forms No. 01, 02 and 03 issued with Appendix I.

The Ministry of Health encourages principal investigators to register and publish their research on reputable domestic and foreign databases.

Financing and payment of drug trial participants in clinical drug trials

Finance for clinical drug trials, according to the draft, the funding for clinical drug trials includes professional contract rental, consumables, support for drug trial participants, insurance... discussed, developed and signed by the principal researcher, the clinical drug trial facility in coordination with the organization or individual with the drug for clinical trial.

The cost of management and supervision of clinical drug trials is for the following activities: surveying and evaluating research sites; meetings, conferences, and workshops related to research; training for research teams; supervision, inspection, and audit... by the principal researcher, the facility receiving the clinical drug trial in coordination with the organization or individual with the clinical drug trial to discuss, develop, and sign a contract.

Organizations and individuals with clinical trial drugs are responsible for paying for clinical drug research costs.

Payment and compensation for damages (if any) to clinical trial participants must be clearly stated in the Research Information Sheet and clinical trial participant's volunteer form and in the research protocol.

According to the draft, the rights and responsibilities of individuals and organizations with clinical trial drugs are implemented according to Article 92 of the Pharmacy Law No. 105/2016/QH13.

The rights and responsibilities of clinical trial facilities are implemented according to the provisions of Article 93 of the Pharmacy Law No. 105/2016/QH13.

The rights and obligations of participants in clinical drug trials are implemented according to the provisions of Article 91 of the Law on Pharmacy No. 105/2016/QH13.

Please read the full draft and give your comments here.

Wisdom