By Pratibha Raju and Abhijeet Singh

Mumbai: Before any new drug therapy treatment or device is made available to the public, stakeholders must ensure that it is both effective and safe for patients. The only measure they have to prove it clinical trialsHowever, looking at the demographic distribution in clinical trial trends in India, there is a clear mismatch between clinical trials and their distribution, pointed out Dr Neelima Kshirsagar, National Chair, Clinical Pharmacology, ICMR.

speaking in etpharma clinical research And the keynote address of the Excellence Conference, Dr. Kshirsagar shared his valuable insights on the topic ‘A vision for clinical research and evidence by 2030’.

In his address, Dr. Kshirsagar emphasized on the discrepancy in the selection of test subjects which affects the efficacy of drugs with respect to their performance on patients living in different ecosystems.

Justifying his claim he provided several data points such as 35 per cent of the tests were conducted in the western region, with the most populous Uttar Pradesh constituting only five per cent of the tests and placing the country at the very top in terms of prevalence of the disease. Place has been given. (infectious and neonatal) more than the number of tests done for it.

He stressed that a large section of the population that lives in aspirational districts, especially the tribal area, remains out of reach for tests.

To overcome this problem, Dr. Kshirsagar also suggested several solutions ranging from fitness bands and chip-based health measuring devices, which he said, “will revolutionize not only health care, but also clinical research.” The scenario will also revolutionize the way data is captured in clinical trials. ,

Adding to the wearable category, he mentioned that in the future, innovations like sleep monitoring pillows, oral health monitoring teeth, sugar monitoring contact lenses etc. will become a reality and will contribute significantly to it. data collection For clinical research.

He also threw light on this by explaining in detail AI controlled Clinical trial design as one of the possible solutions to the latent problem. According to him, these two solutions can go a long way in collecting more data on a more representative sample size in a relatively short period of time.

Quoting a research paper, Dr. Kshirsagar said, “The amount of money available for clinical research or medical matters is kind of flat, it is neither increasing nor can increase.”

Noting the positive aspects of the country’s diversity and large population, he said, “India has the potential to become a global leader and set standards.” drug testing Practice”

In his viewpoint Dr. Kshirsagar gave several other suggestions where he mentioned, Data and AI enabled clinical research cells should be made mandatory by the NMC (National Medical Commission); Doctors and other medical professionals working in rural areas should be skilled for proper data collection and provided opportunities to interact with other professionals to encourage experiential learning, quick digitization of records.

In his concluding remarks, he advocated a collaborative effort by government, academia, and insurers to make the scale of clinical trials more representative, which can help develop more effective drugs in terms of both their performance and cost. Could help.