Clinical
Trials
Phases of clinical trials
Bioequivalence studies
INTRODUCTION
BRIEF HISTORY
Medicines currently available in pharmacies are the result of scientific research. Research in medicine has evolved greatly over the last 50 years, bringing new treatments and innovative medicines to cure numerous diseases and thus prolonging life expectancy.
Any pharmaceutical product, before first being sold in a pharmacy and used for treatment, undergoes a long process of research, testing, confirmation of efficacy, identification of possible side effects and finally being approved for release. Clinical research adheres highly stringent national and international regulations, which are conducted in accordance with the ICH-GCP guidelines and the Declaration of Helsinki, adopted by the General Assembly of the World Medical Association.
METHODOLOGY
THE HOWS AND WHYS
Clinical trials are carried out in different locations, such as hospitals, universities or medical clinics, all accredited for research activities by the relevant regulatory health bodies. A clinical trial may be conducted in a single site or take place in multiple sites in one or more countries (multicentre). Good Clinical Practice (GCP) guidelines are internationally accepted, ethical and science-based quality standards for designing, conducting, recording and reporting trials involving voluntary participation of human subjects.
- Participants' rights, safety, and security in clinical studies are all protected.
- Obtaining valid and reliable data in clinical settings
- Improving the overall quality of clinical research
- Mutual acceptance of data from countries where clinical research projects are carried out
The developement of a new medicine occurs in two stages:
Stage of the pre-clinical trials
Stage of clinical trials
How do clinical trials work?
From concept to praxis
01
Design
the role of the researcher
Researchers design the clinical trial protocol based on the scientific questions they need to answer.
Approval
the role of the regulatory bodies
The protocol is reviewed by the National Medicines Agency (NDA) and the National Ethics Committee, who examine the adequacy of the protocol design, potential risks to participants and potential bioethical issues. The clinical trial can only begin if it is approved as required.
02
Trials
Regular Medicins and placebo
Most clinical trials involve two groups, the intervention group and the control group. Participants in the intervention group receive the medicine under study, while participants in the control group receive a 'placebo' or an already approved medicine commonly used for the disease being studied. Participants are randomly allocated between the two groups.
