Worldwide Clinical Trials to Present “Adaptive Study Designs: Too Clever by Half?” at NORD Summit

Worldwide experts to showcase innovative program design in rare
disease clinical research

MORRISVILLE, N.C.–(BUSINESS WIRE)–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: Oct. 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 http://www.worldwide.com.

Contacts

Worldwide Clinical Trials
Sherri Stuart
Sherri.Stuart@worldwide.com