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Harmonizing Biosimilar Regulations to Improve Patient Access

Health1 months ago

Source: Harmonizing Biosimilar Regulations to Improve Patient Access

Rare disease tests face unique challenges due to small patient population, limited data and complex rules. A patient-centered approach changes the research by including patients from testing design to subsequent marketing. It increases recruitment, retention, and data relevance when creating belief and moral integrity. Technologies such as ePRO and partnerships with advocacy groups support this model. Case studies, such as SMA therapy development, show their success. Finally, the patient-centere