The quality and completeness of clinical trial data being generated in the country, will be a focus area for Indian Society for Clinical Research’s new president Dr Seema Pai, as the organisation clocks 20 years in the country.
Against the backdrop of India undertaking late-stage trials for multinationals companies, and for several years, Pai said, “We have to concentrate on the data completeness and the quality of the data that we are getting in,” for the industry to move up the value chain.
Illustrating her point, Dr Pai told businessline, “if it is a 200 to 300 patient oncology specialised trial and of them 20 patients come from India, we require the data of all the 20 patients in absolute accuracy and complete cell quality. Otherwise, it will skew the results of what it is submitting.”
In fact, data quality and integrity from domestic clinical research organisations had been flagged by top representatives from the United States Food and Drug Administration representatives, over a year ago.
The quality of data mapped in India would contribute to building global industry confidence in early-stage trials as well, Dr Pai said, when viewed along with fortified capabilities in hospital sites, researchers and regulatory systems to handle these trials.
Dr Pai currently leads Pfizer’s global site study operations for the India cluster (India, South Africa & Sub-Saharan Africa).
Reiterating the point of moving up the value chain, she pointed to the several global capability centres that are already working in areas like biostats, medical management etc and said, “what we are doing right now is akin to a lot of offshoring,” that can come under pressure if companies have to rework plans for some reason.
“If we have to really show the Indian might to the world, what the GCCs would require to do is graduate from being just a delivery hub, from a global delivery hub to a capability hub is something where the transition has to be – where we look at … the scientific components to be used from India,” she said, referring to, for example, developing clinical development plans.
The India clinical trials market is valued at $1.42 billion in 2024 and is expected to grow at about 8.0 percent from 2025 to 2030, driven by the pharmaceutical and biotechnology sectors, say industry representatives citing data from Grand View Research, an India and US based market research and consulting company.
And while the clinical research industry plugs its gaps, Pai also urged Government to partner on early-research from companies, especially in areas critical to the country, including diabetes. This would help the industry grow in both early and late stage trial segments. Pointing to regulatory authorities in S Korea and Taiwan, for example, she said, they review global products that are in the pipeline and frame policies around it. While the Indian clinical trial ecosystem has improved, it still has ground to cover in comparison to others in the region like S Korea Singapore, Malaysia etc, she observed, who continuously improve their partnerships and infrastructure.
Published on April 10, 2025
