Clinical Research Vs Clinical Practice
Clinical Research Vs Clinical Practice
Clinical Research Vs Clinical Practice
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.
Medical Practice
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.
Clinical Trial
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.
Clinical Practice
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