R&D activity in drugs is a lengthy, challenging, and expensive process:
The initial phase of drug research consists of determining a molecule from among thousands developed through extensive laboratory studies that can have a beneficial effect on the illmess and contribute to the quality of life.
A patent application is then filed for the discovery rights of the newly discovered molecule (for instance to the American Patent Institute in the US). If the application is approved, patent rights for 20 years are received.
An application is filed for the new molecule to an authority in the pharmaceutical industry (eg. FDA - Food and Drug Administration in the US), and research approval is received.
Laboratory studies are conducted to understand whether the molecule is toxic or not, and its pharmacological effects.
Another application is then filed to authorities for the molecule that is found safe in laboratory environment, and license received to conduct cinical studies and trials on people.
Clinical trials on people, which are conducted on a voluntary basis, consist of 3 phases, and this means a lengthy process.
Phase I is the first phase, and between 20-80 healthy volunteers participate in a controlled hospital environment. The purpose is to determine the drug’s dosage, how it is metabolized in and expelled from the body, and any acute side effects.
Phase II is the second phase, conducted with the participation of 100-300 volunteer patients who have the disease that the drug aims to treat. The purpose is to collect data on the efficacy and safety of the drug.
Phase III is the third phase, conducted with 1000-3000 volunteer patients. The purpose is to see the effectiveness and side effects of the drug, and to compare it with standard therapy. In some cases, clinical trials continue even after the drug is launched in the market.
Phase IV is the phase where the purpose is to collect data on the long term risks and benefits of the drug, as well as its appropriate dosage of administration.
As can be understood, number of participants increase in each phase of clinical trials.
In addition to patients in the country where the study is conducted, others from other countries may also participate. In order for such studies to be conducted in a country, it is preferred that patent, data protection, and intellectual property rights are protected by laws.
As a result of clinical trials, approval is received from authorities for the drug whose safety and benefit is scientifically proven, and it is permitted to launch the drug in the market.
The responsibility of the research-based pharmaceutical company does not end with receiving marketing license. On the contrary, the company should continue research, collect and report new data concerning the use of the drug.
Research-based pharmaceutical companies have developed more than 90 percent of innovative drugs and treatments offered to patients in the last 20 years.