TORONTO, ON--(Marketwired - February 08, 2017) - Join Peter Larson, Senior Medical Director of Hematology-Oncology and Colin Hayward, Chief Medical Officer both from Premier Research for a live broadcast on Tuesday February 28, 2017 at 11:00am EST (4pm GMT/UK) as they --
- Discuss important aspects of rare oncology, including trial design and execution, market exclusivity, and today's regulatory environment
- Examine trends in trial design, including use of the continual reassessment method in Phase 1, use of adaptive design Phases II and III, statistical implications, planning for expanded access, and capturing market access outcomes
- Review regulatory pathways in rare oncology: breakthrough, accelerated/conditional approvals, and orphan designation
Study of rare cancers poses special challenges for drug developers, who often must draw on their experience in both oncology and rare disease. Current strategies and processes for general oncology drug development don't always apply to rare oncology, a field that today accounts for up to 20 percent of new cancer diagnoses.
To optimize drug development, study designs should maximize the percentage of patients on effective treatment and minimize overall sample size to limit patient exposure to drugs or doses that have no effect. This can be achieved through use of adaptive design techniques and more rigorous oversight of patient eligibility to define the optimal trial population.
Researchers should consider alternative statistical principles - for example, estimating survival when further lines of therapy are anticipated - along with interim analyses and proper futility management.
Biomarkers and surrogate endpoints of efficacy, such as response duration and progression-free survival, also need special consideration and may be required as part of the regulatory review process. Collecting information beyond survival is becoming more important, with payers increasingly requiring quality survival be demonstrated. Development plans should encompass expanded access to bridge the gap between clinical trials and market approval.
New regulatory pathways and processes are expediting the translation of novel therapies to the bedside, and understanding these options helps ensure availability of more new treatments while minimizing delays.
For details or to register for this complimentary event visit: http://xtalks.com/Expediting-Development-of-Rare-Cancer-Treatments.ashx
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, oncology, 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: premier-research.com
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.
To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/sponsorship.ashx
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