SOURCE: Xtalks

Xtalks Webinars

November 09, 2015 07:30 ET

Ethical Considerations in Adaptive Design Clinical Trials, Upcoming Webinar Presented by Premier Research

TORONTO, ON--(Marketwired - November 09, 2015) - This webinar will outline adaptive design clinical trials and how the importance of careful design, meticulous planning, and rigorous ethical review cannot be overemphasized. Featured presenters from Premier Research include Thomas Laage, Director of Product Development Consulting and Regulatory Medical Writing Support, and Jennifer Nezzer, Director of Biostatistics. The live one-hour broadcast takes place on Thursday, November 19, 2015, at 11am EST (4pm GMT).

Adaptive design is generally accepted as an advance in clinical trial methodology, but trials planned and executed with AD present special challenges for observing the Belmont Report's ethical principles in research involving human subjects.

In this webinar the speakers will review the features of particular design adaptations and discuss the ethical obstacles they present, and potentially resolve. They will use examples of published and unpublished AD clinical trials, some successful and some less than successful.

The results are as follow:

  • Confirmatory trials for treatments widely accepted on the basis of uncontrolled case series or open-label trials can raise issues about clinical equipoise and "justice" in the sense of who, in the Belmont Report's words, will "receive the benefits of research and bear its burdens." (Infantile hemangioma and propranolol.
  • Analysis of interim results by unblinded data and safety monitoring committees, designed to protect the scientific basis of a trial, can withhold from patients information necessary to make informed judgments. (BIG 1-98 trial).
  • Adaptations can include sample-size reassessment and dose adjustment via dropping or adding treatment arms. This allows fewer subjects to produce a statistically significant result, exposes fewer subjects to ineffective or toxic doses, and gives more subjects doses showing tolerance and treatment activity. (ECMO and Neuromyelitis Optica trials).
  • The increased complexity of adaptive design trials can enhance the challenges of therapeutic misconception. Adaptive randomization can produce inferential problems that must be balanced against any ethical benefit. (Trastuzumab versus taxane in advanced gastric cancer and the ADVENT trials).
  • Successful use of AD can lead to more efficient allocation of societal resources for research, both in the public and commercial realms. (Sunesis VALOR trial).
  • Regulatory acceptance of novel ADs can be uncertain. (Indicaterol trial).
  • New forms of AD, including platform, umbrella, and basket trials, can offer additional efficiencies. (I-SPY II, BATTLE, Lung-MAP, EPOC, and PREPARE trials).
  • Regulatory agencies have adapted to the realities of highly selective and targeted therapies, providing fast-track and breakthrough designations and allowing priority reviews for these treatments.

For more information about this complimentary event (hosted by Xtalks) or to register visit: Ethical Considerations in Adaptive Design Clinical Trials.

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in areas such as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 84 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.

To learn more about Premier Research visit:

About Xtalks

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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