Pharmacoepidemiology – Basic Knowledge

Pharmacoepidemiology – Basic Knowledge

This article provides basic knowledge about pharmacoepidemiology, focusing on ethical principles in biomedical research and clinical trials.

1. Ethical Documents:

• The Declaration of Helsinki was issued by the World Medical Association (C). This document outlines the fundamental ethical principles in medical research, including respecting the rights of patients and protecting their health.

• CIOMS was issued by the Council for International Organizations of Medical Sciences (B). This document provides detailed guidance on ethics in biomedical research, focusing particularly on issues related to research in developing countries.

• Good Clinical Practice Guidelines were issued by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (A). This document aims to ensure the quality and reliability of clinical trials while protecting the rights of research participants.

• General Guidelines on Clinical Trials were adopted in 2001 by the Council of Ministers of the European Union (D). This document sets out common standards for conducting clinical trials in EU member states.

2. Basic Ethical Principles:

• The Nuremberg Code is considered the first international guideline on ethics in biomedical research (B).

• Maximizing benefits and minimizing risks is the content of the principle of beneficence (B) in ethical research principles.

• Protecting the rights of individuals in medical research is the content included in the Declaration of Helsinki (B).

• Principles are regularly reviewed and updated is the content included in the Declaration of Helsinki (B).

• Ensuring the physical and mental safety of research participants in accordance with the principles of the Declaration of Helsinki is the content included in Good Clinical Practice (C).

3. Ethical Issues in Clinical Trials:

• Vietnam began paying attention to ethical issues in biomedical research and clinical trials in the early 1990s (A).

• Payment to trial participants must be clearly stated in the study information sheet (A) and the approved informed consent form (B).

• The ethics committee should have 5-11 members (B).

• If there is no ethics committee, the ethical review will be conducted by the Scientific Council of the unit (A).

• Informed consent consists of three main parts (C).

• In some epidemiological studies such as case-control, historical cohort, not providing the full research purpose may be acceptable to avoid bias (A).

4. Scientific Misconduct:

• Risk factors leading to scientific misconduct include external pressure (A) and research funding (B).

5. Drug Safety Issues:

• Drug safety issues are the responsibility of the registration authority (A).

• Drug use issues (abuse and dependence) are the responsibility of the registration authority (A).

• Issues related to off-label drug use are the responsibility of insurance agencies (B).

• Issues related to comparative effectiveness are the responsibility of insurance agencies (B).

• Issues related to the real value of drugs are the responsibility of insurance agencies (B).

• Issues related to evidence of safety and effectiveness – the basis for implementing treatment guidelines are the responsibility of the professional management agency (C).

• Issues related to drug use evaluation are the responsibility of pharmaceutical companies (D).

• Issues related to effectiveness with efficacy and comparative effectiveness research are the responsibility of pharmaceutical companies (D).

• Issues related to the real-world risk of drugs are the responsibility of pharmaceutical companies (D).

• Issues related to cost-effectiveness and benefit-risk of drugs are the responsibility of pharmaceutical companies (D).

6. Concepts in Epidemiology:

• Sampling frame: A list or map of sampling units (A).

• Sampling unit: The basic unit from which we actually sample (B).

• Observation unit: The subject for which we measure one or more characteristics (C).

7. Errors in Hypothesis Testing:

• Type I error: Probability of rejecting H0 when H0 is true (B).

• Type II error: Probability of accepting H0 when H0 is false (A).

8. Conclusion:

This article only provides basic knowledge about pharmacoepidemiology and ethics in biomedical research. To better understand this field, you need to continue to explore and research further.