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Clinical Trials

What is a Clinical Trial?

Studying and Evaluating Drug Effects on the Treatment Process

A clinical trial is a type of experimental research and the most robust method for proving a causal relationship between a therapeutic intervention and a cure. In general, participants entering a clinical trial are randomly divided into at least two groups: one group is exposed to the therapeutic intervention under study, while the other—the control group—either receives no intervention or undergoes standard treatment. Finally, the results of the intervention are evaluated by comparing the two groups. When experimental research is conducted on humans, it is called a clinical trial, which is currently accepted as the strongest scientific method for evaluating various medical treatments.

A clinical trial is an interventional research study used to compare different treatment methods in humans. Its importance lies in its ability to demonstrate the actual effectiveness of a medical intervention. Numerous studies have proven that improvement can sometimes occur even without an active drug, simply through a sense of support or by providing a placebo. It can be confidently stated that modern clinical trials are the best medical indicator of the 20th century compared to previous eras. Every clinical trial consists of four separate phases:

1

Step One

This phase is the first step in testing a new therapeutic effect in humans. At this stage, only the safety of the new product is examined to determine if it causes severe or dangerous side effects. This phase of clinical research is conducted on healthy individuals and does not address the therapeutic effects of the drug. The study population (sample size) is also very limited.

2

Step Two

In this step, the best administration method for the new drug (e.g., oral or injection) and its most effective dose are investigated. Different doses are used in the treatment groups to ultimately identify the optimal dose with the maximum therapeutic effect and minimum side effects.

3

Step Three

This phase involves research to compare the treatment results of patients receiving the new therapy with those receiving standard treatment. Research generally only reaches this phase if it has succeeded in phases one and two. In Phase 3 of clinical studies, hundreds of people may participate. Finally, based on the results of this phase alongside previous test results, the Food and Drug Administration (FDA) approves and registers the drug in the country’s official pharmaceutical list. With the issuance of the organization’s permit, the drug enters the market.

4

Step Four

All research conducted after the drug enters the market falls into this stage. This is done either to collect more safety data over a longer period and in a much larger population or to gain information regarding other therapeutic effects and alternative uses of the drug.

Our Policies and Position in Clinical Trials

Biosun Pharmed is committed to the following points regarding clinical trials:

  • Guaranteeing the rights, health, and confidentiality of the information of patients participating in the trial.
  • Striving to achieve valuable and verifiable research results.
  • Adherence to the development of new pharmaceutical ethics.
  • Commitment to the resolutions of pharmaceutical ethics committees in the field of clinical trials.
  • Attention to the highest clinical, scientific, and ethical standards.
  • Commitment to all scientific policies, values, visions, and the mission of Biosun Pharmed in clinical trials.
  • Enhancing the scientific quality of research by documenting the clinical trial protocol with full details, including research objectives, design, analysis methods, implementation, organization, and documentation of operational procedures.

Patient Feedback

In this section, research is conducted to compare the treatment outcomes of patients under new treatment with patients under standard treatment. Essentially, this research only reaches the third phase if it has performed successfully in the first and second phases. In the third step of clinical research, hundreds of people may have participated. Ultimately, the Food and Drug Administration approves the drug and registers it in the country’s official drug list based on the results of this phase of research along with the results of previous tests. Thus, with the organization’s permit, this drug enters the market.