A New Era in Dermatology: Study Design, Regulatory Strategies, and Patient Participation

New treatment options for moderate to severe dermatological diseases and areas of high unmet need are driving a revolution in clinical development of dermatology drugs. But questions remain: What indications should be pursued? How to design a study that targets…

A New Era in Dermatology: Study Design, Regulatory Strategies, and Patient Participation

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New treatment options for moderate to severe dermatological diseases and areas of high unmet need are driving a revolution in clinical development of dermatology drugs. But questions remain: What indications should be pursued? How to design a study that targets the right endpoints? And how will environmental constraints affect the research?

This webinar explores dermatology trials from the vantage point of study design, patient access, data quality, regulatory considerations, and more. Panelists discuss what’s required to understand the disease burden, patients’ treatment goals, and critical elements in devising effective recruitment and retention strategies.

Panelists also discuss the importance of careful study design in creating a trial that meets regulatory and safety guidelines and selects endpoints that will demonstrate the value of the investigational drug while staying flexible throughout the trial. The webinar also examines the evolving regulatory environment, emphasizing the importance of early communication with regulators — including what to ask and how.

Other topics include:

– How an innovative clinical development plan can get you to market sooner, with a competitive edge
– Five operational considerations to keep top of mind
– What corners you absolutely cannot cut, and
Best practices in the current clinical development landscape

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