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Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

Regulatory-HTA body collaboration early at the design stage and throughout the entire product lifecycle is key (Shutterstock)

Drug companies should consider randomizing as early as possible in their clinical development program to improve their chances of producing evidence that will be relevant to both regulators and health technology assessment (HTA) bodies.

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