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Vivek Vidyadhar Bhosale, M.B.B.S., M.D.

Principal Scientist, Molecular & Structural Biology

Clinical research: Investigational New Drug (IND) Filing, Phase 1 to Phase 4 clinical trials, Biomarkers, NABL

Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to participate in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care.

There are 4 phases of biomedical clinical trials:

• Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
• Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.
• Phase III studies are conducted on larger populations and in different regions and countries, and are often the step right before a new treatment is approved.
• Phase IV studies take place after country approval, and there is a need for further testing in a wide population over a longer timeframe.

Clinical trials are carefully designed, reviewed and completed and need to be approved by regulatory agencies and institutional ethics committees as applicable before they can start. People of all ages can take part in clinical trials, including children. At CSIR-CDRI we have drafted clinical trial protocol and other documents and successfully filed investigational new drug (IND) applications and received permission from Drug Controller General India (DCGI) New Delhi. We have received permission from DCGI to conduct phase 1 clinical trial of antimalarial drug 97/78, antiosteoporotic drug 99/373 and antiplatelet drug S007/867. We have successfully completed the phase 3 clinical trial of the antiviral drug Umifenovir for Covid-19. The multicentric phase 3 clinical trial of Picroliv in non-alcoholic fatty liver disease (NAFLD) is ongoing at six centres all over India at Delhi, Chandigarh, Mumbai, Hyderabad and Lucknow which is in collaboration with ICMR New Delhi. The Phase 1 clinical of fracture healing drug has been received DCGI permission and is planned at King George Medical University, Lucknow.

In a clinical study, we found that the antihypertensive drug Nebivolol has more tolerability and equal efficacy to Atenol (Vivek et al 2014). The drug Nebivolol, Olmesartan also reduce endothelial microparticles (Jain 2017). We are also working on early diagnosis in the area of metabolic diseases. The assessment of clinical and biochemical parameters predicts the risk of developing metabolic syndrome in young and middle age population. (Vivek et al 2019). Our lab of haematology and biochemistry, received NABL, Quality Council of India accreditation. We have found that blood biomarker Lipocalin levels increased in patients of non-alcoholic fatty liver disease (NAFLD). The Lipocalin level starts increasing before any changes in liver enzymes such as SGPT, and SGOT and the levels increase with the severity of the disease which can be correlated with transient elastography (Chawla et al 2023). We have also found other biomarkers Zinc Alpha 2 Glycoprotein, Hepcidine are useful biomarkers in chronic kidney disease. Our group has dome clinical pharmacokinetic studies for drug-drug interaction. The therapeutic drug monitoring of antimicrobials laboratory is also being developed.

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