What is clinical research?
Clinical research is a branch of healthcare 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 relieving symptoms of a disease.
The term clinical research refers to the entire bibliography of a drug, device or biologic, in fact any test article 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 test article including its safety toxicity and efficacy are studied.
Clinical research is not the same as clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.
Care Partners Clinical Research is currently enrolling patients for studies.
Please contact us to see if you would be eligible to participate.
What does it take to get FDA approval?
In the United States, when a test article is unapproved or not yet cleared by the Food and Drug Administration (FDA), or when an approved or cleared test article is used in a way that may significantly increase the risks or decreases the acceptability of the risks, the data obtained from the pre-clinical studies or other supporting evidence, case studies of off label use, etc. are submitted in support of an Investigational New Drug application to the FDA for review prior to conducting studies that involve even one human. Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption application if the device is a significant risk device or is not in some way exempt from prior submission to the agency.
In addition, clinical research may require Institutional Review Board or Research Ethics Board and possibly other institutional committee reviews and approval, such as Privacy Board, Conflict of Interest Committee, Radiation Safety Committee, Radioactive Drug Research Committee, etc. Clinical research review criteria will depend on which federal regulations the research is subject to and will depend on which regulations the institutions subscribe to, in addition to any more stringent criteria added by the institution possibly in response to state or local laws and policies or accreditation entity recommendations. This additional layer of reviews is critical to the protection of human subjects especially when you consider that often research subject to the FDA regulation for prior submission is allowed to proceed, by those same regulations, 30 days after submission to the FDA unless specifically notified by the FDA not to initiate the study.
Why is it important that doctors be involved in clinical research?
The clinical research ecosystem involves a complex network of research study sites, pharmaceutical companies and academic research institutions. In recent years, the research has led to a growing field of technologies used for managing the data and operational factors of research studies including systems to help automate the management and conducting of clinical trials. Clinical research is often conducted at affiliated research study sites. These sites provide access to larger metropolitan areas, providing a larger pool of actual participants.
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