DIA Adaptive Designs in Clinical Trials: Overcoming Persistent Barriers
Nov 29 2012 8:30AM - Nov 30 2012 4:30PM | Hyatt Regency Washington on Capitol Hill
400 New Jersey Ave NW,
Washington, DC 20001-2097
Clinical trials designed with adaptive features have great potential to result in more efficient decision making within a drug development program, and these potential benefi ts have been recognized by FDA, as expressed in the 2010 draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics. Surveys of adaptive trials designed or conducted in 2008, and again in 2011, with medium to large pharmaceutical companies and CROs have identified barriers to the implementation of these designs. Some barriers have been reduced over time, such as availability of statistical tools and flexible randomization and drug supply systems. Others persist, such as education, change management, pre-planning and simulation, and perceptions of regulatory acceptance.
The goal of this conference is to provide a forum to examine persistent barriers to the use of adaptive design approaches in clinical trials. Recommendations to address these and other barriers will be discussed in an interactive format and within the framework of practical approaches and best practices for conducting adaptive design trials.
Featuring a joint session with the co-located meeting Data Monitoring Committees: Best Practices and Future Directions
- Industry experience to date: review of 2008 and 2011 surveys
- FDA, CDER experience to date, pre and post guidance
- Learning from FDA, Center for Devices
- Considerations for DMCs when adaptive designs are utilized
- Adaptive design approaches for confi rmatory trials
- Case studies in the confi rmatory setting
- Adaptive design approaches in the exploratory setting
- Case studies in the exploratory setting
- Importance of trial simulation
- Learning from the ADAPT-IT grant (Adaptive Designs Accelerating Promising Trials Into Treatments)
Who Should Attend
Pharmaceutical, academic and government senior-level professionals and decision-makers involved in drug development and working in:
- Academic health centers/Investigator sites
- Clinical research & development
- Data Management
- Modeling & Simulation
- Project management
- Regulatory affairs/operations
At the conclusion of this conference, participants should be able to:
- Recognize the benefits and issues with the use of adaptive trials
- Discuss the industry experience to date relative to designing and implementing adaptive trials
- Recognize the progress that has been made in adaptive designs
- Identify persistent barriers to the use of AD approaches in clinical trials
- Discuss answers for solutions to barriers they may be encountering
Group Discounts Available! Register 3 and Get the 4th FREE!
Hotel & Travel
TRAVEL AND HOTEL
Hyatt Regency Washington on Capitol Hill
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until November 7, 2012, or until room block is filled). Attendees must make their own hotel reservations.
Standard Room Rate $199
Address: 400 New Jersey Avenue, NW Washington, DC 20001
The most convenient airport is Ronald Reagan National and attendees should make both airline and hotel reservations as early as possible.
Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102.
As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 1.4 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.
This program is part of DIA’s Certificate Program and is awarded the following.
• Clinical Research Certificate Program: X Elective Units each
For more information go to www.diahome.org/certificateprograms
|DIA Adaptive Designs in Clinical Trials
It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.
Statement of Credit:
If you would like to receive a statement of credit, you must attend the program and tutorial(s), if applicable, sign-in at the DIA registration desk each day of the program, and complete the on-line credit request process through DIA’s My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Friday, December 14.
To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org
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Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.
CANCELLATION POLICY: All cancellations must be received in writing two weeks before
the start of the event. Administrative fee that will be withheld from refund amount:
- Member or Nonmember = $200
- Government or Academia or Nonprofit (Member or Nonmember) = $100
- Tutorial (if applicable) = $50
Cancellations must be in writing and be received two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.