Clinical trials are scientific study on humans in the medical fields which is based on the specific protocol. According to the WHO definition, a clinical trial is any research study that prospectively assigns human participants to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc. In these studies, participants are divided into two or more groups (arm), and investigational interventions are received by one of these groups. Then, by comparison of the outcomes, drugs or new therapeutic methods and the advantages and disadvantages of their use will be assessed. After approving of quality and safety of a new medication by preclinical studies, and also achieving approval from authorities, a clinical study is allowed to be performed. A clinical trial should be conducted under supervision of experienced investigators and based on a specific designed plan called protocol.
Investigators should consider the following matters before starting to conduct a clinical trial:
- Evaluation of eligibility criteria
- Determining the sample size in each arm
- The time required to conduct the study
- Investigating limitation and providing a solution to eliminate them
- dose and route of administrative medication.
- The methods of analysis
Clinical trials of novel pharmaceutical molecules which are first introduced to the world include four phases, each phase has specific objectives are as follows:
Phase Ι of clinical trials:
This phase of clinical trial is performed on limited number of healthy volunteers or patients (in case of chemotherapy agents and medication with high side effects) for the first time to evaluate the safety and determine the effective dose of the drug in humans
Phase ΙI of clinical trials:
This study includes more volunteer or patients (compared to the prior phase) to assess side effects and effectiveness of novel drugs or treatments.
Phase ΙII of clinical trials:
This study included more patients (compared to the second phase) and conducted during a longer time to assess side effects and effectiveness of novel drugs or treatments.
Phase ΙV of clinical trials:
After approving the phase III study outcomes by corresponding authorities, the medicine is allowed to be launched into the market while surveillance of efficacy and safety of the medicine must be continued in a national and global scales.
regarding Iran food and drug regulatory system, to market biosimilar product (recombinant protein products that are similar to the originator’s in terms of efficacy and safety), performing Phase III clinical trials are absolutely mandatory. This phase of study is in order to ensure the efficacy and safety of a biosimilar are similar to the originator’s. CinnaGen Pharmaceutical Group, a leading group in field of chemical and biological production in Iran, is responsible for conducting several clinical trials in the country to ensure the efficacy and safety of its biosimilar products.
Orchid Pharmed as a member of CinnaGen group is assigned to conducting clinical trials. Clinical Trials department of Orchid Pharmed Company includes experts in medical and paramedical science who are currently involving in the implementation and management of clinical trial in the rheumatoid arthritis, oncology, endocrinology, gynecology, kidney and neurologic medicine and another lines will be added in the near future, management and implementation of additional lines will be added to this section.
The overall structure of the phase III of clinical trials
Conducting a clinical trial in accordance with good clinical practice (GCP) is along with many complexities and difficulties. Therefore, the management of a clinical trial project is associated with a lot of interaction with related organizations and agencies.
In the following figure, the bodies involved in a clinical trial is illustrated in detail:
Health Authority: Institutions affiliated to the Ministry of Health which is responsible for Inspection of the sponsor, CRO and investigators to ensure conducting the trial is according to approved protocol and protecting the rights of participants.
- r: Company, institution or organization that is responsible for starting, managing and sponsorship a clinical trial in order to manufacture and market a new medication. The sponsor must audit the trial process, CRO and investigator performance to ensure they do in accordance with approved protocol and GCP considerations.
Contract Research Organization (CRO): Companies with high experience in the field of implementation of the clinical studies that sponsor can delegate all or part of their responsibilities in connection with the project management to them.
- Or principal investigator is a specialist and experienced physician who has the main responsibility for the implementation of a clinical trial that the sponsor appointed them.
- Patients participate in a study. They could be recruited after being informed about the study and signing consent form.
The steps of the clinical study:
The management of a clinical study requires precise planning at every stage:
In the following figure, a clinical trial and what must be done at every stage can is illustrated:
/ Clinical Trial Center /