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Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relief of symptoms in a disease.

[edit] Overview

The term clinical research refers to the entire biography of a drug from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the drug including its efficacy and toxicity are studied.

In the United States, the data obtained from the pre-clinical studies are submitted as an IND (Investigational New Drug) to the Food and Drug Administration (FDA) for permission to conduct human studies. In the European Union, the European Medicines Agency (EMEA) acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give their consent to participate in the clinical trials. Phase 1 trials usually deal with investigating the study drug in a few research subjects who are healthy volunteers. This phase is mainly targeted at identifying the safety, tolerability, and the general mechanism of action of the drug in humans. These studies are usually conducted in tightly controlled clinics called CPUs (Central Pharmacological Unit), where participants receive 24-hour medical attention and oversight. In some diseases in which the therapy under study is known to be too toxic for healthy subjects (some cancer medications, for instance), phase 1 trials are performed in patients with disease to test these parameters.

The goal of phase 2 trials is to grasp additional understanding of the study drug's safety and efficacy and to determine the appropriate dose to be administered to deliver the desired treatment effect while minimizing the safety risk of future research subjects. This usually requires more than 100 patients to demonstrate relevant results, although the actual number of subjects varies widely based on the disease under study. Thus, multiple clinics are utilize to recruit subjects with the disease under study to sufficiently enroll the study(ies) in a reasonable period of time. Often multiple phase 2 studies are required to define the appropriate patient population to study during phase 3. Once the drug is deemed a potentially safe and effective candidate in Phase 2, it is then studied in Phase 3 trials. This phase often exposes more than 1000 research subjects with the disease and is usually performed at many clinics (sometimes well over 100) to enroll the trial (or trials). There is a focus on the effectiveness of the study drug in a variety of demographic and socioeconomic subjects with variants of the disease under study. Usually a comparison is made with standard drugs available on the market. It is imperative that the drug is shown to be effective and safe in this phase.

When phase 3 trials are completed and the data demonstrate safety and efficacy of the study drug, a New Drug Application (NDA) containing all manufacturing, pre-clinical, and clinical data is filed with FDA for review. If deemed safe and effective, FDA grants approval of the NDA, which then allows the company to market product. Usually this approval comes with strict requirements for the company to conduct additional studies to keep the NDA active (usually pediatric trials and additional safety trials).

In phase 4, the aim is to further characterize the safety of the drug through the identification of unknow adverse reactions and potentially researching new therapeutic indications. Companies often use this phase to gain exposure to different physicians and clinics, which aids in the marketing of their product. The entire journey of a drug from lab to market may take approximately 12-18 years and cost billions of dollars.

However, clinical research does not stop here. It continues throughout the lifetime of the drug to include post marketing surveillance where a periodic 'progress report' is submitted to the regulatory authorities once every 2 years after the drug is released into the market and also into Pharmacovigilance where safety of marketed drugs, biologics or medical devices are monitored.

The focus of clinical research is wide enough to include data management, medical writing, regulatory consultation, and biostatistics to name a few.

The clinical trials are regulated by country specific Health Regulatory Agencies such as the U.S. Food and Drug Administration (FDA) in U.S. and in the European Union by the European Medicines Agency (EMEA).

[edit] References

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