Scrutinizing Primary Endpoints in ALS Clinical Trials: ALSFRS-R, Survival or a Composite?
Speaker
Prof. dr. Leonard van den Berg
Neurologist
Prof. dr. Leonard van den Berg is a neurologist at University Medical Centre (UMC) Utrecht and ALS Centrum. He is experienced in conducting global ALS trials, established the prominent TRICALS site network, and is chair of the European Network for the Cure of ALS.
During this webinar, Leonard van den Berg, MD, PhD (Chairman TRICALS | UMC Utrecht, NL) and Ruben van Eijk MD, PhD (Lead Statistician TRICALS | UMC Utrecht, NL) will discuss Primary endpoints in ALS clinical trials, differences in regulatory requirement of the EMA and FDA and statistical considerations.
They touched upon:
- Primary endpoints in ALS clinical trials
- Regulatory requirements: differences between EMA and FDA
- Statistical considerations for ALSFRS-R, survival and composites
Followed by a Q&A session.
Speakers: Prof. Leonard van den Berg, MD, PhD & Dr. Ruben van Eijk, MD, PhD
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