What is Clinical Trial Clinical Research.
Clinical trials is a activity to identify and develop a safe and effective medicine or a treatment for a disease, symptom of a disease.
Patients or people participating in new research are at benifit of getting a latest newer treatment or medicine for the disease.
Clinical Trial Definition: Clinical Trials Research is study of safety and efficacy of a medicinal compound or a physical intervention practice (yoga) on healthy human volunteers, to conclude if the medicinal compound or a formulation or a drug can be used safely to mitigate or treat the disease condition or symptoms of underlying cause developed due to disease conditions or due to surgery or due to physiological disturbances, psychological disturbance (behavior)
Why clinical studies are important:
Clinical studies are conducted with the aim to provide better quality of life which might have been disturbed or worsened due to disease of surgical intervention or an accidental condition, or psychological or physiological disturbances.
People Participating in a clinical trial are called subjects, and the main person who is driving the clinical research is called principle investigator. And any institute or person who is financing the clinical research is called sponsor of clinical trials. Author of a clinical trial is the main person who is guiding the study, here he is investigator, and the people who assist him are
Clinical studies are regulated by US FDA through various regulations, this is to ensure that a unbiased outcome of endpoint of clinical research is reported, and due to wrong reporting people should not get any risk of life and due to proper reporting of outcome a balance judgment can be drawn if the medicine or a drug or a practice is safe, and effective in mitigation of a disease condition or in providing desired relief from disease condition or any other physiological (diabetes) psychological (mental illness) or surgical (to heal surgical wounds, to provide alternative after a surgical removal of tissue or body part) or accidental disturbance in health condition.
Diseases conditions: Viral, Bacterial Infections.
Surgical: to heal surgical wounds, to provide alternative after a surgical removal of tissue or body part)
Following are the stages of a clinical trial:
Stages of a development of medicine or a drug or a procedure or a physical practice (yoga)
1 ) Molecular evaluation: Finding the similarity of a molecule with bio molecules like enzymes and their amino acid, their bonding with body cell, orientation of bonding and molecular orientation, active site on molecule, mode of action of a molecule is established.
Correlation between the physiological changes and practices adapted.( procedure or a physical practice (yoga) )
2) Synthesis and purification and standardization of molecule:
3) Evaluation of the Drug in vitro (experiments of synthetic systems)
4) Evaluation of drug in situ (Evaluation of desired outcome on animal model)
Phases of a Clinical trial
Phase 1: Evaluation of drug or a medicinal compound or a practice on a small number of volunteers usually below 100 numbers. Here the main focus of study is given on the safety of the medicinal product on humans.
Phase 2: Evaluation of a drug or a medicinal compound or a practice on a small number of volunteers usually in greater than 100 numbers. Here the main focus of study is given on efficacy and to reassure safety of the drug or medicinal product or a practice on humans.
Phase 3: In this phase even a large number of participants are enrolled, involving one or more centers or clinics, hospitals etc., and different populations, drugs are combined with other medications and given to patients, which a patient is likely to get in the normal course of treatment. Main focus of this study is to gather data on side effects, adverse drug reactions, drug interactions.
Based on the evaluation and inference of all three phases of clinical trials Food and Drugs Administration gives approval to market the drug product for use on patients.
Phase 4: : This phase of study is a phase which involves conducting a study of the drug product or medicine after it is marketed, the side effects might not come out from the past three phases but may come out in the fourth phase.
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[…] a clinical trial safety and efficacy of Drug Leqembi was evaluated by giving patients affected with mild dementia […]
[…] The accelerated approval pathway is used to approve drugs for the diseases for which there is no other drug or effective treatment is available, in this procedure the primary outcome of the drug study such as an ability to act in vitro on certain biochemical, biochemical assay or other change that a drug if given to the patient will provide the beneficial effect. The outcome of a clinical evaluation or study is called the clinical end point. In actual clinical study many patients are involved and study is done with the drug and an actual effect of the drug is evaluated, which is called the clinical end point. […]
[…] such drug products then are investigated for their safety and efficacy , and after approval clinical studies , a manufacturer generally applies for a patent for the drugs developed by them so as to enjoy […]