India at a jumping-off point in terms of commitment to global clinical studies

Paul Bridges, PhD, President, Consulting, Parexel, and Sanjay Vyas, President of Global Safety Services & Clinical Logistics and Country Head for India, Parexel, shortlist trends that will define 2026 from data protection uncertainty and AI governance to biosimilars' second wind, inspection readiness and India's emergence as a global clinical trials hub. Excerpts from a wide-ranging conversation with Viveka Roychowdhury

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If you were to pick one or two trends in clinical trials and research in India in 2026, what would you be looking at? What are the trends you would track, worry about, or watch closely?

Sanjay Vyas: For me, one is the new data protection act that has just come in (the Digital Personal Data Protection Act, 2023 (DPDP Act)). There is still a lot of uncertainty. Even though the act states that if you use local patients and local vendors you need to ensure data protection, for outside vendors it may not be required. I want to see how this will be implemented.

As a CRO, I am not worried because we are already very high on compliance and data protection processes. But the skepticism remains around how data will be captured, where it will reside and how it will be reported. That is one trend I will definitely track.

The second trend that continues to keep me slightly awake is the applicability of artificial intelligence and machine learning. We are still behind in issuing clear guidelines compared to the US FDA and EMA. They have been very proactive. We have even had a seat at the table with the US FDA, where our chief data officer served as a consultant. They are asking questions like what tools are you using and where AI is being applied across clinical trial processes.

We have not reached that stage in India yet. I would like to see that progress and some clarity emerge.

The third is early phase trials, especially first-in-human studies. I hope that at some point the doors open further and the environment becomes more conducive so that drugs can be made accessible to patients earlier, rather than waiting until phase two or phase three.