AYUSH clinical trials
Types of Clinical Research – Based on Investigational Product
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Types of Clinical Trials – Based on Investigational Product.
Investigational Product
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
In simple terms – Investigational Product or IP is the medicine/treatment on which a clinical trial is conducted. Based on what Investigational Product is used, clinical trials can be classified as follows.
Chemical Entity Clinical Trials.
These are clinical trials conducted on Allopathy medicines. Chemical Entities can be NCE (New Chemical Entity) which means a newly discovered Allopathy medicine. They can also be FDC (Fixed Dose Combination) i.e. combinations of various drugs in one tablet – multiaction tablets.
Medical Devices Clinical Trials.
As per CDSCO, Medical Devices can be classified as follows based on risk.
Class A: Low Risk: Eg: Thermometers, Tongue depressors.
Class B: Low-Moderate Risk: Eg: Hypodermic needles.
Class C: Moderate -High Risk: Eg: Bone fixation Plate
Class D: High Risk: Eg: Heart Valves, Defibrillators, Stents.
Clinical trials on medical devices are predominantly conducted for BIOCOMPATABILITY – how the human body reacts or accepts a foreign body which is intending to diagnose, treat or manage a disease or disorder.
AYUSH Clinical Trials:
Clinical trials on Ayurveda, Siddha, Homeopathy, Naturopathy, can be done on both medicines, cosmetics and even supplements.
Vaccine Clinical Trials:
Vaccine clinical trials can be of two types.
Prophylactic: Developing a new vaccine and doing clinical trial on the vaccine to verify if it prevents a disease or disorder.
Therapeutic: Sometimes attentuated vaccines maybe given as a way of boosting the body’s immune system against a particular disease.
Biologics Clinical Trials:
Clinical trials on medicines or treatments that are derived from biological sources. Eg: Stem cells, Monoclonal antibodies, gene therapy etc.
Clinical Trials on Treatment Systems:
Clinical trials may be done to verify the efficacy and safety of a change in a particular treatment modality. Eg: A new surgical methodology development, cross interaction treatments between different systems of medicine or even developing new treatment systems such as acupressure, acupuncture etc.
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