Clinical Trial

What is a clinical trial?

A clinical trial is an empirical and the strongest type of research to prove the causal relationship between therapeutic intervention and treatment. In general, in a clinical trial, people included in the study are randomly divided into at least two groups: A group undergoes therapeutic interventions and the other, called the control group, is either subject to a standard medical intervention or no intervention. Finally, the results of the intervention are evaluated by comparing the two groups. If an experimental research is conducted on humans, it is called a clinical trial that is now accepted as the strongest scientific method for evaluating multiple therapeutic methods. A clinical trial is an interventional research to compare different therapies in humans. The significance of clinical trials is attributable to its ability to show the actual effect of therapeutic interventions, as several studies have demonstrated that the mere generation of a sense of support or the administration of placebo occasionally leads to partial recovery without the prescription of an effective medication.
It can be strongly argued that today's clinical trials are probably the best medical indicator of the twentieth century compared with earlier centuries. Each clinical trial has four separate stages:

1 Stage

This stage is the first stage to test the new therapeutic effects in humans. In this stage, the mere safety of the new product is examined to determine whether it causes serious and dangerous side effects. This stage of clinical research is conducted on healthy people and does not address the therapeutic effects of drugs at all. The population of the sample (sample size) is also very limited.

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2 Stage

In this stage, the best administration method of a new drug (e.g., orally or through injection) and its best dose are examined; in such a way that the treatment groups take different doses of the drug, and ultimately, the best dose with the highest therapeutic effects and the least side effects is determined.

3 Stage

: In this stage, a study is conducted to compare the treatment outcome of newly-treated patients with those undergoing standard treatment. Basically, the research reaches the third stage only when the first and second stages have been successfully performed. The third stage of clinical research may involve hundreds of people. Finally, the Food and Drug Administration approves this drug based on the results of this stage and those of previous experiments, and registers it on the official drug list of the country. Thus, with the authorization of Food and Drug Administration, the drug will be marketed.

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4 Stage

All post-market studies are included in this stage, whether they are aimed at gathering more information on the safety of the drug when it is consumed in a much larger population and in a longer period of time, or at obtaining information on its other therapeutic effects or uses.

Our policies in clinical trials

Biosun Pharmed Company commits itself to the following points in its clinical trials:

  • Guaranteeing the rights, health and confidentiality of patients' information participating in the trial;
  • Attempting to achieve valuable and reliable research results;
  • Showing commitment to the development of new pharmaceutical ethics;
  • Showing commitment to ethics committees’ approvals on clinical trials;
  • Observing highest clinical, scientific and ethical standards;
  • Showing commitment to all scientific policies, values, perspectives and missions of the Biosun Pharmed Company in its clinical trials;
  • Promoting the scientific research quality by developing a clinical trial protocol with full details including research objectives, design, analytical methods, implementation, implementation organization and procedure codification.

Obtaining patients’ feedback

Biosun Pharmed Company believes that the various stages of clinical trials are of significant value to researchers, patients, participants in the trial, and all practitioners. We commit ourselves to protecting the privacy of patients and trial results (whether positive, negative, or neutral) before taking a step on the road to future studies. We guarantee to protect the rights, health and confidentiality of participants' information in clinical trials.
Despite exceptional meticulousness shown in all phases of clinical trial and drug manufacturing, our pharmaceutical products may still suffer from deficiencies, whether in terms of unexpected adverse effects or appearance such as problems in packaging, injection syringe, vial's cap and the like. We ask all esteemed patients to contact us through this website (here) if such deficiencies are encountered.