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India poised to conduct more decentralized clinical trials: Sanjay Vyas

Yash Ved, Mumbai
Thursday, September 9, 2021, 08:00 Hrs  [IST]

India is poised to conduct more decentralized clinical trials (DCTs) and DCTs are key in enabling inclusion, thus promoting health equity and encouraging better-informed treatment decisions, stated Sanjay Vyas, executive V-P, India country head & MD, Parexel International.

“DCTs also made it possible to extend our reach to tier 2 and tier 3 cities which generally were not accessible. DCTs became a mitigation strategy ensuring smooth functioning of clinical research while addressing challenges associated with in-person site visits, travel restrictions for patients and investigators, and concerns about Covid-19 exposure, among others. Some work in terms of educating patients needs further attention but clearly the pandemic showed that DCTs are the future of clinical trials and the drug development process,” Vyas stated.

The company added that DCTs present the opportunity to drive a more patient-centric model that is designed to implement trials with the patient experience at heart and enable broad participation and ensure that clinical trials reflect the target population while retaining the study's focus.

In India, decentralized trials can help address the challenges faced during patient recruitment.

The company added that due to larger population bases in India and China, global companies that plan investments in newer therapy areas are exploring these countries for research and development. The disease burden is also an important factor taken into consideration in these regions.

Vyas added, “With the easing of regulations, sponsors are now looking to India as an important market for generating critical clinical trial insights. The approval timelines have also witnessed increased agility. What previously took eight months for approval is now being accomplished within three months. This allows for greater flexibility for Indian and multi-national biotech companies to partner and produce results in a shorter timeframe.”

The company added that another growth driver is the increase in healthcare provider standards. The standards of care, quality control, ethic committee oversight, as well as the innate desire of investigator sites to provide better healthcare for patients is further attracting global sponsors to consider India as a favored destination to conduct their studies and better benefit patients.

The growing infrastructure in Tier 2 and 3 cities is enabling consideration for clinical conduct that previously wouldn’t have been possible.

“From a clinical research perspective, there is a growing talent pool in India ranging from pharmacy graduates, biostatisticians, physicians and great potential in areas of recruitment for medical writers, data management professionals, statistic programming teams, bio-statisticians and on boarding more physicians by expanding the clinical operations team and clinical monitors,” added Vyas.

The company stated that Asia Pacific region continues to be one of the major growth markets for clinical trials and added that it would open a new clinical trial supplies depot in China to support timely access to supplies and medications to clinical sites and patients.


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