Worldwide experts to showcase innovative program design in rare disease clinical research
Worldwide Clinical Trials, Inc. (Worldwide), an award-winning, full-service, midsize, global CRO, was selected to present an abstract discussing advantages and disadvantages of adaptive study designs (ASD) in rare disease indications at the National Organization of Rare Diseases’ (NORD) Rare Diseases and Orphan Products Breakthrough Summit on Oct. 15-16, 2018, in Washington, D.C.
To highlight observations gained through protocol development and regulatory vetting of recent submissions of ASDs, Worldwide experts, William L. Slone, Ph.D., fellow, Clinical Research Methodology, and Michael F. Murphy, M.D., Ph.D., chief medical and scientific officer, compiled ASD observations from recent operationally or inferentially seamless phase II/III trial designs.
Research and development of ASDs has shown both pros and cons when compared to traditional development programs.
“These innovative designs are advantageous in their ability to provide program efficiency, flexible timelines, informative interim analyses, and the possibility of exposing more patients to an optimal dose than would otherwise be accomplished through traditional programs, especially in rare disease indications,” said Dr. Murphy. “However, as with most things, these designs also have less favorable attributes, including less precedent, which requires extensive regulatory vetting and trial simulations prior to launch, as well as rigorous protocol development and greater operational complexity. Recent experiences provide balanced insights regarding this innovative and strategic initiative.”
This poster presentation will explore the advantages and disadvantages of ASDs in rare disease studies and discuss the resources required to develop an ASD.
Be sure to stop by during the poster presentation, October 15-16, 2018, to learn more about considering an ASD program throughout the drug development process.
For more details:
- WHAT: Presentation: Adaptive Study Designs: Too Clever by Half? Innovative Program Design and Rare Disease Clinical Research
- WHERE: NORD Rare Diseases and Orphan Products Breakthrough Summit, Washington D.C.
- WHEN: 15-16, 2018
- WORLDWIDE CLINICAL TRIALS EXPERTS: William L. Slone, Ph.D., fellow, Clinical Research Methodology, and Michael F. Murphy, M.D., Ph.D., chief medical and scientific officer
- JOIN US: Click here to schedule a meeting or find out more about the poster presentation.
About Worldwide Clinical Trials
Worldwide Clinical Trials employs more than 1,600 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs – in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, immune-mediated inflammatory disorders (IMID), oncology and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO. For more information, visit https://www.worldwide.com.
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