Anoop Singh: When India Became the Key to a Faster Hemophilia A Trial
Anoop Singh, Advisor- Clinical Research and LifeSciences at PwC India, shared a post on LinkedIn:
”A global sponsor planned a pivotal Hemophilia A trial without India. The reasoning was sound on paper: long regulatory timelines, complex post-trial access requirements, tight EU submission targets.
Then recruitment for previously-untreated patients (PUP) stalled. Months passed. Getting a single new patient became a rare event.
I went back to the team — not with sentiment, with math: where the patients actually were, which centers had real experience, how start-up would sequence to avoid further delay.
Once the first Indian site activated, the eight patients the global plan couldn’t find in a year were recruited in about two months. The study finished eight months ahead of the original plan.
The lesson isn’t ‘always add India.’ It’s that a region moves from optional to decisive the moment you’re honest about where the patients are and what you’re willing to trade to get there.
If you’re weighing whether to add or pull back a country in your next protocol, tell me which one — happy to share how I’d think through it.”
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