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Adaptive Design in Clinical Trials: When and How to Apply

Oct 21 2014 8:00AM - Oct 22 2014 3:00PM | The Hub Cira Centre 2929 Arch Street Philadelphia, PA 19104

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Overview 

There has been a considerable interest and increase in the application of adaptive designs in the pharmaceutical industry, particularly after the publication of the FDA Draft Guidance on Adaptive Design in 2010. Adaptive design has the potential to reduce the cost and length of drug development, and/or improve the probability of success and de-risk drug development. However, there is a lot of uncertainty and questions around the use of adaptive design. In this course we will identify opportunities in early and late phase development where adaptive design may be applied, and use practical examples to demonstrate how to appropriately design and implement such trials in consensus with FDA Guidance.

Course Level: Beginner/Intermediate

What You Will Learn 

  • Traditional clinical trial designs at exploratory and confirmatory stages of development
  • Definition of an adaptive clinical trial
  • Different types of adaptive designs
  • Rationale for adaptive trial designs
    • Myths and myth busters
    • Advantages and disadvantages
  • Different types of adaptive designs
  • Regulatory guidance
  • Change management/planning implementation
  • Statistics
  • Clinical development program simulations
  • Case studies

Who Should Attend 

This course is designed for senior management professionals working in the pharmaceutical and biopharmaceutical industry, including regulatory affairs professionals, clinicians, statisticians and program managers.

Learning Objectives 

At the conclusion of this course, participants should be able to:

  • Explain the principles of adaptive design
  • Describe the regulatory requirements for adaptive design at exploratory and confirmatory stages of development
  • Recognize situations when adaptive design is applicable, and assess whether an adaptive design is the best solution
  • Outline the infrastructure and processes required for optimal delivery of adaptive clinical trials
  • Discuss  the practical aspects of designing and implementing adaptive design trials

Special Offers 

Group Discounts Available! Register 3 and Get the 4th FREE!

Hotel & Travel 

Training Course Location
The Hub Cira Centre:
2929 Arch Street, Mezzanine Level
Diesel Room
Philadelphia, PA 19104
Phone: 267.519.5260

Hotel Information

A) Homewood Suites by Hilton University City Philadelphia, PA
4109 Walnut Street
Philadelphia, Pennsylvania  19104
P. 215.382.1111

A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until October 6, 2014, or until room block is filled). Attendees must make their own hotel reservations, but only after receiving written confirmation from DIA.

Standard Room Rate $179

The Hub Cira Centre is attached to 30th Street Station in Philadelphia.  Shuttle service is available around the University City area (including The Hub location in the Cira Center).  Please contact the front desk for more information.

Reservation Link: http://homewoodsuites.hilton.com/en/hw/groups/personalized/P/PHLUPHW-DIA-20141020/index.jhtml?WT.mc_id=POG

B) The Hilton Inn at Penn 
3600 Sansom Street
Philadelphia, PA 19104
p. 215.823.6240
The Hub Rate: Guest to contact Sabrina Cooper
p. 215.823.6240 e. Sabrina.cooper@hilton.com

Contact Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda and Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199
Susan.Berkelbach@diahome.org

Faculty 

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Continuing Education 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

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 1.3 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.

CERTIFICATE PROGRAMS

These programs are part of DIA’s Certificate Program and are awarded the following:
• Clinical Research Certificate Program: 8 Elective Units each
• Project Management Certificate Program: 8 Elective Units each
• Regulatory Affairs Certificate Program: 8 Elective Units each

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Adaptive Design in Clinical Trials: When and How t IACET 13.00 1.300

Disclosure Policy:

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 course, sign-in at the DIA registration desk, and complete the on-line credit request process through 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 two weeks after the last day of the course.

To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE

Registration Fees 

Member

Charitable Nonprofit/Academia Member Individual
$810.00
Member Government Individual
$810.00
Member Standard Individual
$1375.00
Member Standard Individual (As of 10/01/2014)
$1475.00

Non-Member

Charitable Nonprofit/Academia Nonmember Individual
$1035.00
NonMember Government Individual
$1035.00
NonMember Standard Individual
$1700.00
Group Discounts

 Printable Registration Form

Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 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 this 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.

Register Online

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.

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