What is a clinical trial?
Hundreds of clinical trials of different phases start all over the world. Most clinical trials are conducted in the USA.
A clinical trial is a scientific research which involves healthy volunteers or patients. The studies are conducted to assess efficacy and safety of medicinal products.
Clinical study is the most important tool to evaluate safety and efficacy of a new drug.
Clinical trials are conducted in accordance with Good Clinical Practice or GCP.
Good Clinical Practice (GCP) is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. GCP is the basis of the Russian State standard, GOST Р 52379-2005.
GCP compliance provides public assurance that the rights, safety and well-being of human subjects involved in research are protected.
It assurance the quality, reliability and integrity of data collected.
The protection of clinical trial subjects is consistent with the principles set out in the Declaration of Helsinki adopted at International Conference on Harmonisation, ICH.
Clinical trials are the most important element of drug development.
Clinical trials provide information on drug efficacy and its side effects.
No new safe and effective drugs can appear without performing clinical trials.
Clinical trials are very well regulated and controlled by international and local regulatory bodies.
Clinical trials quality in Russia is one of the highest in the world.
Country participation in global clinical trials magnifies country’s scientific potential and brings benefits to the community.
International clinical trials can be regarded as an investment into the country, a possibility that the drug is efficient in local population.
Only after clinical trials are conducted and it is determined that the medicine is safe in people and effective for the disease in question pharmaceutical and biotechnology companies can apply for a drug registration. No clinical trials can be registered without performing clinical trials.
There are usually 3 main phases of clinical trials:
- Clinical trial of I phase
- Clinical trial of II phase
- Clinical trial of III phase
Based on the results of clinical trials, an application can be either admitted or rejected. Regulatory bodies do not grant approval, if the results of clinical trials showed that the drug is not safe or efficient.
Even if the results of clinical trials are negative, the results can be of high value for the scientific community. Thanks to the studies, scientist can understand the disease better and can move forward in search of new efficient treatments of a disease.
If the results of the trials are positive and the drug is safe and efficient, the drug will be registered and the doctors will prescribe it to its patients.