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FDA Panel Discusses Role of Patients in Clinical Trials for Rare Diseases




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Purohit fdating Tejashri sheth

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We offer you all the chances to build a family and be happy. Dreamy company s surround site and your adoration. There are 2 questions she stressed were imperative to ask when it comes to an orphan drug application: And 2 Is the disease rare? Clinical data has the strongest support for drug effectiveness, she said, adding that animal data in an appropriate animal model can also be accepted if the pathophysiology is relevant to the specific drug and disease in question. Oftentimes, rare diseases have to race against a fast clock since they can be fast-progressing and irreversible in nature.

As such, the panelists discussed the importance of weighing the risks versus the benefits for each situation. Unger pointed out that if the risks of a treatment outweigh those of the disease, that can be a deterrent for the treatment.

Purohit-Sheth added that sufficient and substantial evidence gdating safety and effectiveness always have to be considered with a treatment; considering the pathophysiology is also important. Unger added that "because many rare diseases are slowly progressive, the usual end points—how patients feel, function, or survive, are not practicable. For situations where diseases take many years to progress, it can be useful to use a surrogate endpoint as the basis of accelerated approval. After an accelerated approval is granted, it is incumbent on the company to then develop the clinical benefit long-term. In other words, the company has to prove to the FDA they were correct in saying this treatment is effective.

Purohit-Sheth added that if an endpoint that is readily measurable for survival can be assessed in a reasonable timeframe, it is better to measure that endpoint than go with a surrogate endpoint.





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