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ASH and FDA Unveil New Recommendations to Guide Clinical Development of Sickle Cell Disease Therapies
The American Society of Hematology (ASH) today released the most comprehensive set of recommendations to date aimed at establishing uniformity and global standards for clinical trial endpoints used to evaluate new therapies for sickle cell disease (SCD). The new recommendations – published in two companion papers in the current issue of Blood Advances – are the result of seven expert and patient led panels convened by ASH and the U.S. Food and Drug Administration (FDA) to improve the design of clinical trials for new SCD therapies, including promoting broader use of patient reported outcomes and biomarkers as clinical endpoints.
Sickle cell disease is the most common inherited red blood cell disorder in the United States, and it affects millions of people worldwide. In people living with SCD, the red blood cells, which are normally round, become crescent or sickle-shaped which contributes to the vaso-occlusive crises these patients experience.
education & researchNovel Use of Hydroxyurea in an African Region With Malaria: Protocol for a Randomized Controlled Clinical TrialBackground: Sickle cell anemia (SCA), ...
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news & eventsEmmaus Life Sciences Launches Its Commercial Co-Payment Assistance Program for Endari™Emmaus Life Sciences, Inc., a leader in ...
news & eventsHHS Secretary Alex Azar Touts White House Efforts to Fight Sickle Cell DiseaseBy 2029, Americans with sickle cell dise...
people & placesSam Rodgers-Melnick, MT-BCSamuel Rodgers-Melnick, MT-BC is a music...
news & eventsSickle Cell Foundation Nigeria, Rhieos Develop 1st Multi-SCD Registry in NigeriaIn a bid to improve quality of care for ...
news & eventsHydroxyurea improves lung function in children with sickle cell diseaseFor the first time, researchers were abl...
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This platform is made possible through a partnership with the Sickle Cell Disease Association of America, Inc. (SCDAA) and its member organizations. SCDAA's mission is to advocate for people affected by sickle cell conditions and empower community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.