The pharmaceuticals available in today's pharmacies are the fruition of extensive medical research, a field that has witnessed remarkable progress over the past 50 years. This evolution has not only led to the development of new therapies and innovative medicines but has also significantly contributed to the treatment and cure of various diseases, consequently extending human lifespans.
Researchers foresee that every second child born today has a strong likelihood of surpassing the age of 100, owing to the advancements in medical research.
Before any medicinal product reaches pharmacy shelves for the treatment of diverse ailments, it undergoes a rigorous process involving research, testing, efficacy confirmation, identification of potential side effects, and eventual approval for marketing.
Clinical research operates under stringent national and international regulations, following guidelines such as the ICH-GCP (International Conference of Harmonization - Good Clinical Practice) and the Helsinki Declaration, adopted by the General Assembly of the World Medical Association.
All European states, the USA, Canada, Japan, and numerous countries worldwide adhere to these international regulations to advance medical science for the betterment of humanity.
Clinical trials take place in various locations, including hospitals, universities, medical practices, or clinics, all certified for research activities by competent health authorities. These trials may be single-center (in one country) or multicenter (in multiple countries), with most involving human volunteers conducted simultaneously across regions like the European Union, the United States, Canada, Japan, the Russian Federation, Australia, and New Zealand.
Countries with a rich tradition in pharmaceutical clinical research are leaders in the number of clinical trials conducted per capita, with the USA holding the first position followed by European Union countries.
Good Clinical Practice (GCP) Guidelines, internationally accepted ethical and scientific standards, ensure the protection of study subjects' rights, safety, and well-being, the acquisition of valid and reliable data in clinical trials, improvement of overall research quality, and mutual acceptance of data across countries where clinical research projects are conducted.
For additional information on clinical trials, you can visit the websites of the
Phase 0:
A recent form of optional exploratory trials, Phase 0 (micro-dosing studies) aims to accelerate the development of promising medicines or imaging agents. It involves administering sub-therapeutic doses to a small number of subjects (10-15) to collect preliminary data on the agent's pharmacokinetics. While it does not provide data on safety or efficacy, it aids in the decision to proceed with drug development based on human models.
Phase I:
Involving 20 to 100 healthy volunteers or volunteers with a specific illness/condition, Phase I trials determine the safe dose and potential side effects. Subcategories include Phase Ia (single ascending dose) and Phase Ib (multiple ascending dose).
Phase Ia (single ascending dose):
Small groups of healthy volunteers receive a single dose of the investigational medicine, with safety observed and tested over time. Dose escalation continues until safety levels for possible therapeutic doses are met.
Phase Ib (multiple ascending dose):
Investigates the pharmacokinetics and pharmacodynamics of multiple-dose medicinal products by assessing safety and tolerability.
Phase II:
Administering the investigational medicinal product to patients with the target condition, Phase II trials involve several hundred patients, providing safety information for the design of Phase III protocols. Subcategories include Phase IIa (proof-of-concept) and Phase IIb (definite dose-finding).
Phase IIa:
Pilot studies designed to demonstrate clinical efficacy or biological activity ("proof of concept" studies). These trials are typically involving small numbers of patients with the target condition (from 12-200 subjects).
Phase IIb:
Studies that aim to establish the optimal dose showing biological activity with minimal side effects (“definite dose-finding” studies).
Phase III:
Involves administering the investigational medicinal product to a larger number of people (thousands of patients) over several years to determine continued effectiveness and potential side effects. It may also compare the investigational medicinal product to others already in use.
Phase IV:
Post-marketing studies that monitor side effects or problems occurring after several years of use or test the treatment in different prevention or therapy settings.
