What exactly is clinical research?
What is Clinical Research?
Clinical research is a branch under the healthcare sciences that is responsible for finding out the effectiveness and safety of medical devices, medications, diagnostic products and treatment regimens that are intended for human use in the cure of diseases and illnesses. Clinical research is used for the diagnosis, prevention, treatment, relieving or alleviating of symptoms of a disease, and is much different from clinical practice. The major difference between clinical practice and clinical research is this - clinical practice works with only established treatments, while clinical research works with the evidence collected to make a treatment established.
Clinical research starts from the inception tests in the lab to it's licensing and introduction to the consumer market. It goes through stages of tests which are called Phases, which is done with the main purpose of testing the effectiveness and safety of a drug for human use.
Bodies Concerned With Clinical Research
In the European countries, the European Medicines Agency (EMA) is the body that conducts clinical research studies. Human subjects that have given their informed consent are allowed to participate in the clinical trials as research subjects in the 4 phases of clinical research.
In the United States, the conduction of clinical research is a little more complex. The cases of drugs or treatments and the case of medical devices.
A new treatment that has not yet been approved or cleared by the Food and Drug Administration (FDA) cannot be given a license. So also, an approved or cleared treatment that is used in a manner that greatly decreases the efficiency of the drug or greatly increases the risks of the drug. Their clinical research data has to be submitted to the FDA through the support of an (IND) Investigational New Drug application. This enables the FDA to review the new treatment before they are used to conduct studies involving human subjects. After all proper investigations by the FDA, the new drug can now be licensed and advertised.
In the case of devices, if the clinical device shows signs of significant risk or has not been exempted or licensed by the FDA, then the clinical research data has to be submitted to the FDA through the support of an (IDE) Investigational Device Exemption application. This process may also require approval from any of the following; Institutional committee reviews, Radiation Safety Committee, Conflict of Interest Committee, Privacy Board, Radioactive Drug Research Committee, Research Ethics Board (REB) or the Institutional Review Board (IRB), whether or not it has been submitted to the FDA.
Criteria for Review
The criteria for the review of all clinical research depends on the following;
• Federal regulations that the research falls under and is subjected to.
• The regulations the institutions subscribe to.
• The response to local, state, federal laws, policies, rules, regulations, or accreditation entity recommendations.
The last criteria for Review is done by the IRB or ERB in concordance with the regulatory affairs to protect human subjects.
Where Do Clinical Researches Take Place?
Clinical researches usually take place at affiliated research study sites, hospitals, healthcare clinics, or academic medical centers. These places are strategically placed to provide the competence of the academic institutions involved as well as provide closeness to the medical participants pool.
The ethical issues and conducts of clinical research is overseeing and supervised by their internal institutional review boards.
There are lots of professionals involved in the world of clinical research, as it is a complex network of pharmaceutical companies, academic research institutions, and biotechnology companies. All these has led to the fast growth of technologies used in the operational factors and management aspects of clinical research.
The operational factors are overseen by clinical research professionals such as, CRAs, CTAs, CRCs, and others, while the management aspects of clinical research are overseen by CTMs, CRMs, CRPMs, CrDMs, and others.
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