Department of Clinical Research
Barij Essence Pharmaceutical Company
A clinical trial is a study whereby the subjects are the patients. In the United States approximately 10% of medicines that enter the clinical evaluation process are eventually given permission to be sold. Designing and implementing a good clinical trial requires the cooperation of a physician or a clinical pharmacologist with a statistician and many other specialists. The main goal of a clinical trial is to evaluate a new treatment for a disease and/or to find a suitable prevention mechanism for an illness or a complication including but not limited to death and physical disability.
In general, the most important goals of clinical studies include:
1. Developing a logical connection between the laboratory and clinical research
2. Determining the effectiveness of interventions in progress
3. Facilitating interventions that seem to have been successful
The purpose of researchers in clinical trials is testing therapeutic methods on studied subjects and observing their effects. By using various methods such as randomized distribution or blind studies, researchers try to eliminate or minimize possible effects of bias in study results.
A comprehensive definition of clinical study is the following:
Any study done on humans to discover or verify the clinical and medical effects or pharmacodynamic effects of a research product, to identify any adverse reactions to a research product, or to study the absorption, distribution, metabolism, and excretion of a research product in order to prove its safety or efficacy.
A good and ethical clinical practice includes the following:
1. International standards of design
2. Proper implementation
3. Monitoring and inspection
4. Data entry
6. Reporting of clinical trials
Various stages of designing a clinical trial include:
1. Selection of patients
2. Determining the number of required patients
3. Random distribution of patients into research groups
4. Blinding the study to avoid any bias
5. Determining the inclusion and exclusion criteria
6. Measuring the basic variables
7. Evaluating the responses of each patient
8. Observing any occurred side effects during the study
9. Preparing the final report
The main types of studies used in clinical trials include:
1. Longitudinal studies: this is a type of an observational study in which a process is studied over a long period of time, such as a cohort study or a case-control study.
2. Cross-sectional studies: this is a type of an observational study in which collected data is examined at a particular point in time and the data is more descriptive.
Due to the fact that herbal medicines have been well embraced, conducting clinical trials in order to ensure their effectiveness and safety use has been a priority on this department’s agenda. The goal of the department of clinical research is to provide effective and safe medicines with minimal side effects. In this regard, numerous research studies have been conducted and their articles have been published in national and international journals.
1. Management of clinical trials for the production of herbal medicines
2. Training the therapeutic courses related to medicinal herbs
3. Developing therapeutic herbs
1. Maryam Nikzad, MD—Clinical Expert
2. MahnazMahlooji, Bachelor of Midwifery—Clinical Expert