Real-world evidence (RWE) clinical trials and India’s unique advantages have taken the pharma industry by storm. RWE, derived from real-world data (RWD), provides clinical evidence on the use of medical products and their potential advantages or risks. Compared to traditional clinical trials, RWE holds immense potential for improving patient outcomes by offering more profound insights into real-world practices. Physicians, biotech companies, and pharmaceutical firms are now recognizing the tremendous value of RWE in enhancing health outcomes.
Harnessing RWE in the Wake of the COVID-19 Pandemic
The COVID-19 pandemic has propelled the industry to harness RWE for innovation at an unprecedented pace. Vaccine development companies, particularly, have leveraged RWE to optimise site selection and gather valuable information from diverse populations. This data has been instrumental in understanding vaccine effectiveness across various demographics, including gender, age, race, and ethnicity.
In RWE studies, India stands at the forefront, offering many exciting opportunities across diverse fields. Some include exploring the natural history and long-term effects of non-communicable diseases like heart failure and drug-resistant tuberculosis. Additionally, India provides a conducive environment for creating registries for orphan/rare diseases like thalassemia. Moreover, Indian-prescribed doses, typically lower than Western doses, can be subjected to comparative effectiveness research against package insert recommended doses. RWE studies also enable research on health outcomes and health economics in public versus private hospitals and identify unmet medical needs specific to the Indian population.
India’s Favorable Position in the Healthcare Sector
India’s competitive pricing in the healthcare sector positions it favourably against Western countries. By 2023, the healthcare sector in India is projected to reach a staggering revenue of $516.60 million. Looking ahead to 2027, the market volume is expected to surge to US$766.40 million, with an estimated compound annual growth rate (CAGR) of 10.36%. As healthcare spending as a percentage of GDP continues to rise, a significant opportunity exists to enhance healthcare services in the country. Notably, over 70% of Indians reside in rural areas, making them a potential source of demand. Key healthcare data sources in India include community health centres, government-private hospitals, and health insurers.
Challenges and Collaborative Initiatives in Harnessing RWD/E in India
Despite these advantages, India needs help in effectively harnessing RWD/E. The availability of electronic medical records, data quality, lack of medical compliance and follow-ups, and insurance and claims data pose significant hurdles. However, concerted efforts are underway to fully utilise RWD/E in India, including establishing patient registries and integrating digital healthcare solutions.
While India may be slightly behind other nations’ regulatory authorities in fully realising the potential of RWD/E to revolutionise healthcare, collaborative initiatives are gradually taking shape. Efforts are being made to coordinate RWD sources through initiatives like the National Digital Health Mission and Ayushman Bharat Yojana. However, India’s journey in this regard requires time, patience, and a steadfast commitment to consistently gather essential data, standardise data collection tools, and expand the scope and coverage of medical insurance.
Conclusion: Leveraging RWE for Transformative Impact
RWE clinical trials have gained traction in the pharma industry, offering efficiency, accuracy, and numerous benefits from real-world data. India’s vast population, diverse disease landscape, and varied healthcare perspectives provide an ideal backdrop for conducting RWE studies. While the potential of RWD/E in India is yet to be fully realised due to various factors, including demand from regulators, payers, insurance companies, and patients, the industry is witnessing a growing interest in leveraging RWE to transform healthcare.
Innvocept Global Solutions: Empowering RWE Clinical Trials for Transformative Impact.
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References
- https://www.biospectrumindia.com/views/17/22097/real-world-evidence-is-india-ready.html
- https://www.obviohealth.com/resources/the-rise-of-real-world-data-in-clinical-trials-rwd-improves-clinical-trial-outcomes
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- Dang A, Vallish BN. Real world evidence: An Indian perspective. Perspect Clin Res. 2016;7(4):156-160. doi:10.4103/2229-3485.192030
- https://www.statista.com/outlook/dmo/ecommerce/beauty-health-personal-household-care/health-care/india#revenue
- https://www.analyticsinsight.net/real-world-data-and-evidence-the-future-of-indian-clinical-trials/