The Undeniable Significance of Clinical Trials

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Clinical trials are primarily used for testing the efficacy and safety of medications and medical devices. These are usually funded by drug manufacturers and are carried out by research teams consisting of physicians and other health professionals. Generally, with a Clinical Research Institute trials are performed in four stages:


– Phase one is when the treatment is usually offered to healthy individuals to check whether or not the consumption of the drug or procedure has any undesirable toxicological impact; 

– Phases two and three delve more into the safety, efficacy, and dosing of the medicine, and it is after this phase that the Food and Drug Administration (FDA) will authorize the sale of the product/medication or highlight issues.

- Phase four looks at potential applications for therapies already approved.

Stringent guidelines control all stages of clinical testing and are closely supervised by several regulatory agencies, ranging from top-level authorities, such as FDA, to relatively small Independent Review Boards (IRBs). 

IRBs are autonomous groups comprised of scientific professionals, reputable ethicists, and the likes. Research teams document the findings to the IRB on a regular basis, detailing parameters such as patient interactions, tests carried out, results observed, as well as the adverse effects identified if any. All reputable IRBs are certified by the Accreditation of Human Research Protection Programs (AHRPP).

Approximately 4,000 new drug treatments are currently active in clinical trials; This figure will continue to swell as progress is made in disease identification, determining the underlying causes of acute and chronic ailments.

Impact of Clinical Trials

Within a short span of 20 years or so, (i.e., between 1980-2000)  the age-related mortality rate, especially for cardiovascular ailments in the United States alone has almost halved. Clinical Research Institutes have played a significant role in this achievement. 

To know more about the workings of a Clinical Research Institute, visit us now at https://www.fomatmedical.com

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