SAVE THE DATE
February 10, 2015 | 1:30 - 5:00 PM
Tutorial 1: Bayesian Methods for Drug Safety Evaluation and Signal Detection
Tutorial 2: Bayesian Safety
As the complexity of pharmaceutical development escalates, researchers must leverage increasingly sophisticated statistical tools for design and analysis, including broader use of Bayesian methods and adaptive designs. There has been an upturn in interest and application of adaptive design and Bayesian statistics, in part due to their inclusion within the FDA's Critical Path Opportunities List.
While these methods have already contributed in many ways to reductions in risk, time, and cost of medical product development, and to overall improvements in decision making; for many drug developers, device, and diagnostic manufactures adaptive design and Bayesian statistics are still buzz-words. Per a recent survey conducted by DIA’s Bayesian Scientific Working Group, education continues to be a significant gap in a broader appropriate uptake of Bayesian methods, including their use in adaptive designs. In order to improve the implementation of adaptive design and Bayesian statistics, we must demystify the practice and application of these proven methodologies.
February 2015 marks the 5th anniversary of the publication of the FDA’s draft guidance on adaptive clinical trials and the final guidance of the use of Bayesian statistics in medical device clinical trials. Join us to celebrate these important milestones for clinical trials as well as to engage FDA representatives in discussions regarding the progress of both adaptive design and Bayesian statistics and to speculate the future for this science.
This conference will present the latest advancements in the application of adaptive design and Bayesian statistics to include critical aspects such as a better understanding of methodologies, identifying opportunities for when to apply them, analysis, and improved decision making. Presentations will be given from statistical, clinical, and regulatory viewpoints to provide a more complete picture of appropriate adaptive design and Bayesian statistics implementation.
Sessions will consist of joint and independent adaptive design and Bayesian statistic plenaries as well as concurrent breakout sessions for each class of methods. Case studies will be presented throughout the conference to encourage discussions and debates regarding the use of Bayesian and adaptive design methods within modern medical product development from presenters across industry, regulatory, and academia.
This program has been developed in collaboration with the DIA Adaptive Design Scientific Working Group and the Bayesian Statistics Scientific Working Group.
- 5th anniversary of FDA’s final guidance of the use of Bayesian statistics
- 5th anniversary of FDA’s draft guidance on adaptive clinical trials in medical device clinical trials
Who Should Attend
Professionals from industry, academia, and government involved in medical product development from learning to confirmatory phases or in new drug/device application review:
- R&D Design-makers
- Comparative Effectiveness
- Evidence Based Medicine
- Regulatory Scientists
- Safety and Pharmacovigilance
- Post Marketing
At the conclusion of this meeting, participants should be able to:
- Apply concepts related to adaptive design and Bayesian methods
- Identify opportunities for improving pharmaceutical, device, and diagnostic product development by application of adaptive design and/or Bayesian statistics
- Assess whether the application of adaptive design and/or Bayesian methods would improve metrics such as cost, time of development, and probability of success, compared to the application of more traditional method
EARLY BIRD RATE!
DIA Industry Members who register by
January 22, 2015, save $150!
Group Discounts Available!
Register 3 and Get the 4th FREE!
Hotel & Travel
Double Tree by Hilton Washington DC - Crystal City A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until January 19, 2015, or until room block is filled). Please note: In order to receive the reduced room rate, hotel reservations must be made with Travel Planners and not directly with the hotel. Contact information for Travel Planners is as follows: Attendees can follow this link to make reservations online, or call toll free in the US 1.855.355.0302 or +1.212.532.1660. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #15009.
Standard Room Rate: $172
Hotel Address: 300 Army Navy Drive, Arlington, VA 22202
Warning: Unauthorized Solicitation
The most convenient airport is Ronald Reagan Washington National Airport or Washington Dulles International Airport - attendees should make both airline and hotel reservations as early as possible.