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Real World Data Adoption About 10% Amid Challenges: Parexel Executive

Innovation Hub Set Up In India

 
• By Vibha Ravi

While real world data is reliable, synchronization challenges limit its use, Sanjay Vyas, executive vice president and managing director Parexel India tells Scrip in a wide-ranging interview that touches on aspects from synthetic analytics to the interest among Indian companies in developing cell and gene therapies

Clinical Research Vector
Clinical Research Is Evolving With Real-World, Synthetic Data • Source: Shutterstock

Real world data has been gaining credence among regulators for decisions on drug approval and label expansion given that randomized clinical trials take place in controlled environments in a well-defined population that might also not be truly representative of ethnic or gender diversity.

After the US Food and Drug Administration (FDA) made its first label expansion based on real world evidence in 2019 for Pfizer Inc.’s Ibrance (palbociclib), it turned into a...

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