BRIEF REVIEW ON CLINICAL TRIALS
About Author:Ratnadeep V. Ghadage.
Department of Pharmaceutical Chemistry,
Appasaheb Birnale College of Pharmacy, Sangli,
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. Clinical trials examine the safety and efficacy of interventions, or treatments, in human subjects. This manuscript focuses on pharmaceutical clinical trials. The word subject is used deliberately here, since all participants in clinical trials are subjects, even if they are under the care of a personal physician, and therefore patients in that context, at the time of the trial. The pharmaceutical industry is now a more significant investor in clinical trials, but in addition to these opportunities, it is being challenged by the financial impact of managed care and medicaid regulations on academic medical-center revenues. Besides that, there is growing public concern about our systems for protection of human subjects, along with some conflicts. There are public expectations that clinical research will yield substantial advances in the health of the public. Once clinical research studies are completed and a drug has been approved for marketing by a regulatory agency, reports of the drug’s safety and efficacy will be published in the clinical literature. This dissemination of the results provides clinicians and research scientists with evidence of the beneficial administration of the drug.
Refrence Id: PHARMATUTOR-ART-1147
Clinical trial is an inextricable link between advances in medical research technology and improved health care. It is a component of medical health research intended to produce knowledge valuable for understanding human disease, preventing and treating illness and promoting health. A clinical trial is the scientific term for a test or study of a drug, therapy, surgical procedure, medical device, or of nutrition or behavioral changes in people.
The tests are done to find out if the drug, therapy, procedure, etc. is safe and effective for people to use. The overall purpose of a clinical trial is to learn, not to treat patients. Before you volunteer to participate in a clinical trial, ask about any risks associated with the treatment being tested.
Objectives of Clinical trial:
- To assess the safety and effectiveness of a new medication or device on a specific kind of patients. (E.g. patients who have been diagnosed with Alzhiemer “s disease).
- To assess the safety and effectiveness of a different dose of a medication that is commonly used (e.g.10mg dose instead of 5mg dose).
- To assess the safety and effectiveness of an already marketed medication or devices for new indication.
- To assess whether the new medication or device is more effective for the patient’s condition than the already used, standard medication or device.
Approval of clinical trials: Preclinical data obtained from animal’s studies provide a general pharmacological, toxicological and pharmacokinetic profile of the new drug.
These data are scrutinized by Expert Government Bodies in each country, with aim that clinical drug trials should be undertaken with great care and meticulous planning of the methodology adopted.
The New Drug Application (NDA) in the prescribed format, with all relevant literature and pre-clinical data must be submitted to the Drug ControlAuthority (DCA) for scrutiny, and sanction obtained before clinical evaluation studies are initiated.