Clinical research is one of the most important branches of medical science, which determines the effectiveness and safety of drugs, medicines, diagnostic products, devices and course of treatment for human beings. There are different categories and wings of clinical research, which entails the basics of the course. Students learning clinical research should know some of the key points of this course for better understanding. Knowing the basics of clinical research is a preparatory step for students.
According to the U.S. National Institutes of Health (NIH), clinical research is divided into 3 broad categories:
- Patient Oriented Research and Trial: This type of clinical research is conducted involving humans or human origin materials like specimens or tissues. It also includes mechanisms of different human diseases, clinical trials, therapeutic interventions, and new technology development.
- Behavioral and Epidemiologic Studies: This process involves the examination of diseases are distributed, factors affecting health of people and how people make decisions related to health.
- Health Service Research and Results: This process endeavors to identify efficient and effective interventions, services, and treatments for conditions.
Clinical Research Basics and Principles
There are a few general principles and ethical basics of clinical research that was prepared by the Council for International Organizations of Medical Sciences (CIOMS), United Nations Educational, Scientific and Cultural Organization (UNESCO), and World Health Organization (WHO). With these principles clearly entailed, it was established that clinical research that involved human subjects are to be conducted according to the basic ethical principles – it includes beneficence, respect for the subject, and justice.
There are 6 key areas of focus, which every clinical research learner needs to master:
- To participate in a clinical research, subjects must give their full consent and they may even withdraw their consent at any point of time.
- Clinical research is conducted to provide some major potential benefits to the society, although not to the subjects directly.
- Clinical research experiments should be designed as well as conducted in order to avoid injury to the participants or subjects.
- Clinical research is not the same as medical care – learners should understand the difference.
- Ethical committees conducting clinical research must review and approve research that involves humans. Committees like institutional review boards (IRBs) and independent ethics committees (IECs) should also monitor research.
- Justice is a key point when it comes to clinical research – research should ensure that people share the burdens and benefits of clinical research equally.
With all these important conditions applicable for clinical research, it makes the process of research authentic, ethical, and full-proof.