WHAT IS CLINICAL TRAIL ?A Clinical Trial is series of test that scientist need to conduct when they come up with new ideas for new drug, new medical procedure OR Medical devices. FOR THE Duration of entire clinical process these are called investigational product. When it comes to surgical procedures, often times the new surgical tool/devices or new drugs need to be approved from the DCGI. FDA approval is needed by drug companies who would like to make claims on their products.
ExampleWhat happens when a scientist at a drug company is looking to come out with a new drug for asthma? He is in a lab with a team of colleagues, and they are looking at biological mechanisms of asthma. They brain storm different treatment solution for Asthma by using computer models and other analytical contributes to asthma symptom. Clinical research constitutes three important stage FOR BRINGING NEW drugs to market such as:1. Drug discovery2. Preclinical testing and3. Clinical trialsWith molecule design, they move on to preclinical trial, which involve testing the drug on animals, such as glabrats and guinea pigs. Animals studies are done in the preclinical stages to test the effects of the drugs in none human subjects. With good results from preclinical studies we move on to clinical trials.
1.1 Drug discovery process (Development of promising drug candidate) The drug discovery process includes all early in-vitro (vitro is “glass” in Latin) research activities, which are carried out for identification of new drug molecule. By the end, researchers hope to have a promising candidate drug to te3st in people. Discovery of drug involves, comprehensive understanding about disease to be treated and its cause. This in turns, requires understanding, how the genes are altered, how that affects the proteins they encode and how those proteins interact with each other in living cells, how the disease affects the entire patient. This knowledge is the basis for treating the problem. For more easy perception, the drug discovery process is detailed in step-wise manner as follows:
a. Target identificationThe target-based drug discovery begins with identifying the function of a possible therapeutic target and its role in a disease. This target is generally protein in nature and may be a single molecule such as a gene, protein, enzymes, ion channels, receptor etc. This may believe to have linked to a particular disease or disorder. E.g., role of HMG Co-A reductive enzyme in Hyperlipidemia. The human or pathogen contains thousands of targets and the variety of their respective sub-products; making the target identification as one of the challenging tasks in drug discovery process.
b. Target validationAfter identifying the target, it is necessary to understand that a molecular target is critically involved in a disease process, and that modulation of the target is likely to have a therapeutic effect. Validation involves studies in intact animals or disease- related models that can provide information about the response of an organism to a p0harmacological intervention and it will help to know; whether target is relevant to the disease being studied through complicated experiments in both living cells and in animal models of disease.
c. Lead identification A key to drug discovery is a search for molecule or ‘lead’ compound that may act on their target to alter the disease course. If successful over long odds and years of testing, the lead compound may be found out from various sources such as natural product screening (plant origin or animal origin), combinatorial chemistry, molecular modelling, biotechnology etc. In lead identification the number of promising molecules after extensive testing results in a molecule called “Hits”. Hit compounds are further studied in details for their physical, chemical and biological properties which end with Lead candidates.
d. Lead optimization
It is process which refines the chemical structure of confirmed lead molecules and its pharmacological characteristics to obtain compound with suitable pharmacodynamic and pharmacokinetic properties to become a drug. With one or more optimized compounds in hand, research is further carried out to next step called as pre-clinical testing to determine whether the compound is safe and if they should move on to testing in humans.
