Clinical Research - The Final Frontier of Drug Discovery

Dr. Prasenjit Das (RKMV 1993 Batch)

In a thought-provoking Praktani Adda held on November 11, 2023, Dr. Prasenjit Das, a distinguished alumnus of RKMV from the class of 1993, delivered a captivating address on Clinical Research and provided invaluable insights into the Drug Discovery. The session was moderated by his fellow batchmate, Dr. Abhishek Kumar.

Dr Das began by outlining the structure of the adda which included introduction  about clinical trials, stakeholders of Clinical Research, brief history and going deeper into the regulations in this area and then concluding with different careers in this field.

In order to help the audience gain more out of his session he at the outset explained important terms in this field like IP i.e Investigational Product, observational studies, interventional studies etc. He then moved on to the drug development process where he explained preclinical trials, different phases, marketing application process, FDA review and others.

Drug development process has lots of regulatory requirements and stringent supervisions. In the stakeholders section our speaker deep dives into the role of Sponsor organization, the CRO, research sites, the regulatory body i.e FDA, Institutional Review Boards (IRBs) which is also the Ethics committee and the interconnection between their working and how they affect the clinical research.

Dr Das briefly explained the  simple trial design on how the sample is taken for trials, what are control groups & treatment groups and other factors involved in a clinical trial. 

In clinical trials safety of samples or any patient involved is of utmost importance, and the author frequently stresses as to how important it is in this field.  He then shared a real case study undertaken by an organization to better grasp all the  concepts he explained earlier and showing real data so that the audience can better understand the whole process.

He also shared a  brief history about clinical trials e.g.  James Lind was a Scottish physician who conducted one of the first ever clinical trials. He also explained how un-ethical practices were followed during World War - II and also during study of untreated syphilis in the US during 1932-72.

He then discussed the testing and approval of Covid-19 vaccines, why those vaccines were given fast track approval and the merits and demerits of such approval.

Finally, Dr Das thoroughly explained all the career options and the job profiles in the area of clinical research. The floor was then opened for a Q & A session.

Praktani Adda Session 51 : Clinical Research - The Final Frontier of Drug Discovery

Adda Recording Link: https://www.youtube.com/watch?v=Kj5ghaKNwFw