Clinical research is a current knowledge-oriented and booming industry. It is one of the industry growing at an amazing rate and widening the scope of employment opportunities for trained people. It includes scientific analysis of the risks,impacts and benefits of medicines or a medicinal product. The trials are performed before initiating the products to the market. The tests are performed at different stages and after-delivery supervision is maintained to scrutinize the safety and monitor the side effects if any.
Good clinical practice is an international quality standard that is
provided by ICH, a global body that defines standards, which various
governments can exchange into regulations for clinical trials
involving human subjects. A similar guideline for clinical research
on medical devices is the international standard ISO 14155, that is
valid in the European Union as a coordinated standard. These
standards are sometimes referred to as ICH-GCP or ISO-GCP to
differentiate between the two and the lowest grade of advocacy in
Clinical Research ≠ Clinical Practice
In Clinical research special training is needed, it must be conducted according to the written protocols with a full understanding of the risks to the subjects. The regulations,laws and guidelines for Clinical Research are detailed and specific.
Clinical Research includes any experiment that involves a test article and one or more human subjects.
It might be any experiment in which a drug is administered to or used involving, one or more human subjects. For the same purpose, an experiment is any use of a drug except for the use of marketed drugs in the course of medical research.
Clinical Practice: It is to exercise an occupation or profession
No protocols are required; can be administered to all patients. Some documentation is needed, It is not intended to publisher and billable to insurances.
Clinical Research: It is systematic investigation designed to contribute to generalizable knowledge
I needs protocols; it is administered to some patients. Much documentation is needed,intended to publish and not billable to insurance.
Clinical Trials Vs Medical Practice
Clinical trials are not to evaluate a medicine under actual practice conditions,but rather under selected and often artificial conditions to answer best the trails' objectives.
Controlled clinical trials by definition cannot mimic actual medical practice conditions.
The practice of medicine combines both science as the evidence base and skill in the application of this medical knowledge in combination with intuition and clinical judgment to determine the treatment protocol for each patient.
There is off-label use of biologics, marketed drugs and medical devices.
If physicians use a product for an indication not in the approved labeling they have the authority to be well informed about the product, to base its use on firm scientific rationale and on good medical evidence and to maintain records of the product's use and effects
However the institution at which the product will be used may, under its own authority , require institutional reviews and insights.
Includes a comparison test of a medication or other medical treatment, versus a placebo , other medications /devices, or the standard medical treatment for a patient's conditions
Researcher tests hypotheses and observe what happens. Clinical trials can be viewed as the application of the scientific method to understand human biology.
Clinical trials are closely authorized or guided by appropriate regulatory authorities. All studies that involve a medical or therapeutic intervention on patients must be approved by an ethics committee before permission is granted to run over the trial.
The investigation and use of approved marketed products differs from off-label use. Investigatory use suggests the use of an approved production in the context of a clinical study protocol. When the principal intent of the investigatory use of a test article is to develop information about the product's efficacy or safety , submission of an IND or IDE may be required