Clinical research is another branch of healthcare science which is utilized in determining and investigating the safety and effectiveness provided by a type of medication, clinical device, the products used for diagnosing any disease or disorder and the treatment regimens for the use of human. This all research may be useful in prevention of any type of disease, to provide a guideline to patients for treatment, diagnosis of a particular disease or for relieving and providing aid to symptoms of a disease. Clinical research is generally considered different from clinical practice. In clinical practice established, recognized and approved treatments are used while in clinical research observations and evidences are collected for establishment of a treatment.
The terminology “clinical research” is referred as a research which gives the complete as well as brief bibliography regarding a drug or device. After the identification of candidate or a molecule for medication, it is further forward and subjected to preclinical studies or animal studies where the test article is investigated further like, about the safety and toxicity after its application and efficacy if possible, these all aspects are studied in brief.
Investigational New Drug (IND)
In United States (US) whenever a test article is not approved or forwarded by the Food and Drug Investigation (FDA), or when an article after being approved and cleared is found to be used in a way that might gradually increases the risks (or gradually decreases the rate of acceptability of the risks) all the data collected from pre-clinical researches or bunch of other supporting observations over case studies are submitted in Investigational New Drug (IND) application to the FDA to conduct such studies that are involving at least a person or an approved article.
Investigational Device Exemption (IDE)
Where approvement of devices is aimed , then Investigational Device Exemption (IDE) is employed where it is assured that the device is not a significant risk for any one or the device is not in some way free from further submission to FDA.
Clinical Research in addition might be in requirement of Institutional Review Board (IRB) or Research Ethics Board (REB) and probably many other reviews from such institutional committees. Approvals from Privacy Board, Radioactive Drug Research Committee, Conflict of Interest Committee etc that whether the research deserves to be further forwarded to FDA or not.
Clinical Research Reviews
The reviews of Clinical research depends on the fact that on which federal regulations the relative research is subjected to and varies from the dependency of the institution on the type of federal regulations.
Clinical researches are conducted at academic medical centers as well as such research study sites which are affiliated. These centers facilitate with the advantage of working under an academic institution and the sites provide benefit of having access to large metropolitan areas as well as vast variety of medical participants. These academic institutions normally contains their own Institutional Review Board whose purpose is to look over the working and conduction on medical research.
Clinical research has proved to be a milestone in the aim of improving the quality of aid all over the world.