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Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes

Mar 18 2014 8:30AM - Mar 20 2014 4:00PM | Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, MD 20852 USA

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Overview 

Study endpoint measures in clinical trials determine what conclusions can be made about treatment benefit, medical differentiation, and value. For medical product developers, this evidence plays a critical role in drug development futility decisions as well. Measure selection varies depending upon the development phase and the specific objectives of the trial. Balancing the measurement objectives with various drug development stakeholder interests requires thoughtful planning and consideration. Evidence requirements to support labelling and promotion claims can require substantial time and effort to coordinate, especially when endpoint measures must be developed de novo. During this workshop, attendees will have the opportunity to gain insight into the tradeoffs and various stakeholder perspectives for developing a study endpoint measurement strategy. Day three of this workshop will provide detailed and practical tips for ensuring that measurement tools are adequate to support the targeted objectives with a focus on establishing instrument content validity for the specified clinical trial context of use.

Who Should Attend 

This meeting is for Industry, Academia, Government, Vendors, Clinicians, and Health Technology Agency professionals involved in setting, executing or evaluating endpoint strategy for drug approval, labeling, promotion, translational science and market access.

Specific roles may include:

  • Biostatistics
  • Clinical R&D
  • Commercial
  • Epidemiology
  • Health Outcomes (including Patient-Reported Outcomes and other Clinical Outcomes Assessment)
  • Market Access (Health Economics, Pricing and Reimbursement)
  • Medical Affairs
  • Project Management
  • Regulatory
  • Translational Medicine

Learning Objectives 

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

  • Recognize the challenges sponsors face with setting an endpoint strategy and prioritizing the endpoint objectives across multiple internal stakeholders
  • Discuss the scientific methods, issues and execution challenges for each of the respective internal and external stakeholder’s endpoint goals
  • Explain how to populate and employ strategic drug development tools such as the Target Product Profile to facilitate study endpoint objectives and regulatory interactions
  • Discuss the characteristics of a clinically meaningful measurement instrument
  • Apply good measurement principles to the development of clinical trial endpoints
  • Discuss why the “context of use” is important to developing, evaluating, and interpreting meaningful measurements and appropriate measurement procedures
  • Describe the key steps in meaningful measurement starting with establishing the conceptual basis for a patient-focused clinical outcome measure of treatment benefit

Special Offers 

GROUP DISCOUNT AVAILABLE!
BUY 3 AND GET 1 FREE!!!

Hotel & Travel 

The conference will be held at the Bethesda North Marriott Hotel and Conference Center. 
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until February 28, 2014, or until room block is filled). Please Note: In order to receive the reduced room rate, hotel reservations must be made through Travel Planners, and not directly with the hotel.  Attendees can make their hotel reservations with Travel Planners by clicking here or calling +1.212.532.1660 or in the USA at +1.800.221.3531. When calling please select option 1 for “Hotel Reservations”, inform the phone agent that you are making a reservation for Event #14023

Standard Room Rate $199
Rate includes complimentary internet in the meeting rooms booked using link or phone number noted above.

Hotel Address: 5701 Marinelli Road, North Bethesda, MD 20852

The most convenient airport is Washington Dulles International Airport – IAD or Ronald Reagan Washington National Airport - DCA and attendees should make both airline and hotel reservations as early as possible.

Contact Information 

Printable Registration Form

Registration Questions
Customer Service Department
Toll Free: 1.888.257.6457
Phone: +1.215.442.6100
Fax: +1.215.442.6199
CustomerService@diahome.org

Agenda Details
Karen Tenaglia
Phone +1.215.442.6196
Fax +1.215.442.6199
Karen.Tenaglia@diahome.org

Event Logistics
Benjamin Zaitz, Event Planner
Phone +1.215.293.5803
Fax +1.215.442.6199
Benjamin.Zaitz@diahome.org

Tabletop Exhibit Information
Jeff Korn, Exhibits Associate
Phone: +1.215.442.6184 
Fax: +1.215.442.6199
Jeff.Korn@diahome.org

Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for up to 18.75 contact hours or 1.875 continuing education units (CEU’s). Type of Activity: Knowledge

ACPE Credit Requests
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.

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; +1.703.506.3275.

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 1.9 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: 12 Elective Units
• Project Management Certificate Program: 8 Elective Units
• Regulatory Affairs Certificate Program: 12 Elective Units

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

Name Credit Type Max Credits CEU
Beginning with the End in Mind – Study Endpoints: ACPE 18.75 1.875
Beginning with the End in Mind – Study Endpoints: IACET 18.75 1.900

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 program, sign-in at the DIA registration desk each day of the program, 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 Thursday, April 3, 2014.

Pharmacy Credit Allocation
Day 1: 6 contact hours or .6 CEUs; 0286-0000-14-034-L04-P
Day 2: 6.75 contact hours or .675 CEUs; 0286-0000-14-035-L04-P
Day 3: 6 contact hours or .6 CEUs; 0286-0000-14-036-L04-P



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

Program Committee 

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Agenda  

Day 1 Tuesday, Mar 18, 2014

  • 8:30AM - 8:45AM

    Welcome and Opening Remarks: How Study Endpoints are Used and Why


    Session Chair(s):

    • Linda S. Deal, MS
      Head of Patient-Reported Outcomes
      Shire, United States

    Welcome and Opening Remarks: How Study Endpoints are Used and Why

  • 8:45AM - 9:30AM

    Commercial Interest in Study Endpoints


    Session Chair(s):

    • Joseph C Caminiti
      Executive Vice President, Director Client Services-Professional
      H4B Catapult division of Havas Health, Inc., United States

    Topics presented in this session include:
    - The value of pharmaceutical agents and treatments depends on the proven efficacy, safety, and quality of care versus an accepted comparator.
    - There are potential differences in demonstrating efficacy and safety vs. suitability for P&T inclusion and/or reimbursement.
    - Commercialization involves leveraging the intrinsic properties of a compound to develop promotional strategies around the unique product attributes that provide value for physicians, patients, and payers
    - Exploiting these “unique” properties with product promotion and sales support activities that support successful market launch and growth needs to be supported by data.

  • 9:30AM - 10:15AM

    Translational Medicine: The Bridge Between the Beginning and the End


    Session Chair(s):

    • Francisco Leon, MD, PhD
      Vice President, Translational Medicine, Immunology Department
      Janssen R&D, United States

    Translational Medicine bridges pre-clinical and clinical development. “Reverse Translation” planning often results in recommendations for the development of patient-reported outcomes and biomarkers in Early Development. Challenges and case studies will be discussed.

  • 10:15AM - 10:30AM

    Refreshment Break
  • 10:30AM - 11:15AM

    Addressing Study Endpoints for Clinical Relevance


    Session Chair(s):

    • Debra G. Silberg, MD, PhD
      Senior Director, Clinical Development
      Shire Specialty Pharmaceuticals, United States

    Diseases can be evaluated by changes in physiology, signs and symptoms. When performing a clinical study, it is important to determine the endpoint that is most clinically relevant, discussing with both clinicians and patients what they are looking for from the treatment. The view may not always be the same, but should be taken into consideration when evaluating efficacy. This talk will discuss different endpoints from the viewpoint of both the patient and clinician.

  • 11:15AM - 12:00PM

    Study Endpoints: A Market Access Perspective


    Session Chair(s):

    • Mohan V Bala, PhD
      Head Oncology Value & Access
      Sanofi, United States

    Topics presented in this session include:
    - Overview of Market Access process and evolving concept of Value
    - Relevance of study endpoints for Market Access
    - Payer perspective on endpoints from key countries: A few illustrative examples
    - Study endpoints and Market Access: what does the future hold?

  • 12:00PM - 1:00PM

    Lunch
  • 1:00PM - 1:45PM

    What Does Differentiation Mean to You and How You Select Endpoints?


    Session Chair(s):

    • William Jacobson, PhD, MSc
      Medical Director, CNS, Clinical Science
      Takeda Development Center Americas, United States

    Topics presented in this session include:
    - All Stakeholders want differentiation – are we talking about the same thing?
    - What is(are) the priority(ies)? How are these determined/traded off? Are there specific scenarios that influence this e.g. first in class, best in class, second generation of same mechanism of action (i.e. potential generic competition), etc.?
    - Speaker representatives of the Stakeholder functions to participate
    - The regulatory tight rope

  • 1:45PM - 2:30PM

    Tools to Help Gain Alignment in the Project Team


    Session Chair(s):

    • Charles T Gombar, PhD
      United States

    There is more than one way to develop most new drugs. A key challenge in pharmaceutical R&D is establishing and maintaining alignment on the development strategy and plan in the project team. This talk will highlight some tools that can be used to ensure that a development plan is aligned with the value proposition for the new product.

  • 2:30PM - 2:45PM

    Refreshment Break
  • 2:45PM - 3:30PM

    Beginning with Differentiation in Mind – Easier Said than Done


    Session Chair(s):

    • Linda S. Deal, MS
      Head of Patient-Reported Outcomes
      Shire, United States

    Because yesterday’s blockbuster is today’s generic, the complexity of the development process for new drugs includes raised approval, adoption and reimbursement hurdles. To be competitive and truly groundbreaking, pharmaceutical and biotech companies must be willing to begin earlier in development to evaluate an asset’s potential to differentiate. And, because developing a new endpoint/outcomes measure takes time and investment, an early understanding of the end target(s) is critical when evaluating whether an existing clinical outcomes measure will be sufficient, whether it will need to be adapted, or whether a new measure needs to be developed, for addressing the program goals. The current state of regulatory challenges for study endpoints requires early planning and must be integrated into and accounted for within the overall development strategy. Internal company infrastructure, processes and governance may also present a challenge and may need to be reengineered to meet patient-centric objectives while still adhering to competitive timelines that optimize return on research and development investment and patent terms. This session further emphasizes the case for beginning early with the intention to differentiate, and discusses some of the internal and regulatory challenges to carrying out this objective.

  • 3:30PM - 4:00PM

    Wrap Up and Summarize the Day

Day 2 Wednesday, Mar 19, 2014

  • 8:30AM - 8:45AM

    Welcome and Refresh of Day 1/Introduction of Day 2 Agenda: What Does it Take to Achieve the Study Endpoint Goals Discussed in Day 1?


    Session Chair(s):

    • Linda S. Deal, MS
      Head of Patient-Reported Outcomes
      Shire, United States

    Welcome and Refresh of Day 1/Introduction of Day 2 Agenda: What Does it Take to Achieve the Study Endpoint Goals Discussed in Day 1?

  • 8:45AM - 9:30AM

    Adaptive Designs and Endpoint Selection (Via Telecommunications)


    Session Chair(s):

    • Scott M Berry, PhD
      President and Senior Statistical Scientist
      Berry Consultants LLC, United States

    The selection of endpoints in the learn phases of trials can be a very difficult problem typically involving the time of the trial, the relevance of the endpoint, and the power of the study. Many times decisions to select short term endpoints, for the sake of speed of getting to phase III can create poor dose selection, incorrect go/no-go decisions, and inefficient drug development. The issue can be more complex in an adaptive trial design because of the need to provide information for the adaptations. A strength of the adaptive design is that it can utilize endpoints in different ways -- early markers can be used as possibly correlated to the more appropriate long-term endpoint, and this correlation can be modeled and informed by the trial, and thus the design can be made more efficient and yet the focus is on the more relevant long-term clinical endpoint. In this talk the selection of endpoints, the modeling of different endpoints, within the building and simulation of an adaptive clinical trial will be discussed. Real examples of endpoint selection within adaptive designs will be presented.

  • 9:30AM - 10:15AM

    Overcoming Regulatory Challenges in Targeting Patient-Centered Outcomes in Psychiatric Drug Development


    Session Chair(s):

    • Thomas P. Laughren, MD
      Director
      Laughren Psychopharm Consulting, LLC, United States

    Selecting the primary measure for a definitive trial and defining the primary study endpoint are critical steps in any drug development program. There is increasing interest in using patient reported outcome (PRO) measures in registration trials, and these measures present many challenges, including regulatory challenges. Included among the regulatory challenges are redundancy with investigator rated measures and pseudo-specificity. This talk will discuss possible approaches to overcoming these and other regulatory challenges associated with PROs.

  • 10:15AM - 10:30AM

    Refreshment Break
  • 10:30AM - 11:15AM

    Patient-Centered Outcomes Targeting Payers and Regulators


    Session Chair(s):

    • Ethan Basch, MD, MSc
      Director, Cancer Outcomes Research Program; Associate Professor of Medicine
      University of North Carolina At Chapel Hill, United States

    Payers seek information about the comparative value of products, and increasingly consider the patient experience as an important component of value. Patient-reported outcome (PRO) data may be desired or requested by payers including information about symptoms, functional status, harms of care, treatment preferences, and/or quality of life. There is some overlap with the informational needs and published guidance of regulators. New standards for PROs have also emerged from several entities involved with evaluating comparative effectiveness and quality of care.

  • 11:15AM - 12:00PM

    Study Endpoints and Patient-Centered Outcomes: Payer Needs vs. Regulatory Limits


    Session Chair(s):

    • Paul Radensky, MD
      Partner
      McDermott Will & Emery LLP, United States

    Payers are increasingly asking for value information to support coverage and pricing decisions about new drugs and medical devices. Sometimes the data payers want do not fit squarely within the labeling of the medical product. Many were hopeful that Section 114 of FDAMA and the guidance on Patient-Reported Outcomes would reduce uncertainty about what manufacturers could communicate to payers about their products, but much uncertainty—and potential risk—remains. This talk will explore the regulatory landscape for payer communications and consider some options to bridge payer needs and regulatory limits.

  • 12:00PM - 12:15PM

    Question and Answer
  • 12:15PM - 1:15PM

    Lunch
  • 1:15PM - 1:30PM

    Recap of Morning Session and Introduction to Afternoon Session: Measurement to Achieve Labeling and Promotion Claims


    Session Chair(s):

    • Linda S. Deal, MS
      Head of Patient-Reported Outcomes
      Shire, United States
    • Elektra Johanna Papadopoulos, MD, MPH
      Medical Officer, Study Endpoints Labeling Development, CDER
      FDA, United States

    Good measurement principles form the foundation for clinical outcome measurement. Investment in measurement will ultimately benefit people with diseases, drug developers, clinical trialists, and regulatory authorities. This session will provide an overview of the comprehensive process of creating and implementing a new outcome measure or modifying an existing instrument. The development of a patient-based, clinical outcome measure that will support a labelling claim requires advance planning in the early phases of product development. Establishing the context of use and planning the protocol for qualitative research that thoroughly explores the conceptual basis for measurement are fundamental. This session emphasizes the importance of identifying what is meaningful to be measured based on the context of use for measurement, getting the content right, and finally, ensuring that the measure is meaningful and interpretable.

  • 1:30PM - 3:00PM

    Navigating Instrument Development Using the Wheel and Spokes


    Session Chair(s):

    • Jessica Voqui, PharmD, MS
      Regulatory Review Officer, Study Endpoints and Labeling Development, CDER
      FDA, United States

    This session will give an overview of the process of instrument development as illustrated by the Wheel and Spokes diagram. Responses by EMA and OPDP representatives will explain the relevance of this diagram to their regulatory settings.

    Speaker(s):

    • Roadmap to Patient Focused Outcome Measurements in Clinical Trials
      Elektra Johanna Papadopoulos, MD, MPH
      Medical Officer, Study Endpoints Labeling Development, CDER
      FDA, United States
    • EMA Response (Via Telecommunications)
      Maria Isaac, MD, PhD, MSc
      Senior Scientific Officer, Product Development Scientific Support Department
      European Medicines Agency, European Union, United Kingdom
    • OPDP Response
      Elaine Hu Cunningham, PharmD
      Sr. Regulatory Review Officer, OPDP, CDER
      FDA, United States
    • Panel Discussion Moderator
      Jessica Voqui, PharmD, MS
      Regulatory Review Officer, Study Endpoints and Labeling Development, CDER
      FDA, United States
    • Panelists
      Elaine Hu Cunningham, PharmD
      Sr. Regulatory Review Officer, OPDP, CDER
      FDA, United States
    • Maria Isaac, MD, PhD, MSc
      Senior Scientific Officer, Product Development Scientific Support Department
      European Medicines Agency, European Union, United Kingdom
    • Elektra Johanna Papadopoulos, MD, MPH
      Medical Officer, Study Endpoints Labeling Development, CDER
      FDA, United States
  • 3:00PM - 3:15PM

    Refreshment Break
  • 3:15PM - 4:30PM

    Spoke 1: Defining the Clinical Trial Context of Use


    Session Chair(s):

    • Ashley F. Slagle, PhD, MS
      Endpoints Reviewer, Study Endpoints and Labeling Development, CDER
      FDA, United States

    Good measurement depends on a clearly defined context of use, including explicit consideration of the targeted disease definition, patient population, clinical trial design and objectives, clinical practice, and other aspects of the study setting.

    Speaker(s):

    • Context of Use: An FDA Perspective
      Ashley F. Slagle, PhD, MS
      Endpoints Reviewer, Study Endpoints and Labeling Development, CDER
      FDA, United States
    • Context of Use: Industry Perspective
      Debra G. Silberg, MD, PhD
      Senior Director, Clinical Development
      Shire Specialty Pharmaceuticals, United States
    • Context of Use: Patient Advocate Perspective
      Cynthia Bens
      VP, Public Policy, Accelerate Cure/Treatments for Alzheimer's Disease (ACT-AD)
      Alliance for Aging Research, United States
    • Panel Discussion Moderator
      Ashley F. Slagle, PhD, MS
      Endpoints Reviewer, Study Endpoints and Labeling Development, CDER
      FDA, United States
    • Panelists
      Debra G. Silberg, MD, PhD
      Senior Director, Clinical Development
      Shire Specialty Pharmaceuticals, United States
    • Cynthia Bens
      VP, Public Policy, Accelerate Cure/Treatments for Alzheimer's Disease (ACT-AD)
      Alliance for Aging Research, United States
  • 4:30PM - 4:45PM

    Wrap Up and Adjournment of the Day
  • 4:45PM - 5:45PM

    Networking Reception

Day 3 Thursday, Mar 20, 2014

  • 8:30AM - 8:45AM

    Welcome and Refresh of Day 2/Introduction of Day 3 Agenda: Attention to Measurement in Clinical Trials: Why it Matters


    Session Chair(s):

    • Elektra Johanna Papadopoulos, MD, MPH
      Medical Officer, Study Endpoints Labeling Development, CDER
      FDA, United States

    Welcome and Refresh of Day 2/Introduction of Day 3 Agenda: Attention to Measurement in Clinical Trials: Why it Matters

  • 8:45AM - 10:15AM

    Conceptualization and Generation of a Draft Measure


    Session Chair(s):

    • Elektra Johanna Papadopoulos, MD, MPH
      Medical Officer, Study Endpoints Labeling Development, CDER
      FDA, United States

    Along with a clearly defined context of use, clear conceptualization provides the foundation for the process of instrument development. This is particularly important in clinical trials for regulatory purposes because the concept of interest becomes the labelling claim. Once there is clarity in conceptualization, the qualitative research process may begin.

    Speaker(s):

    • Spoke 1: Conceptualization and Making the Case for Content Validity
      Donald L Patrick, PhD, MPH
      Professor, Health Services, School of Public Health
      University of Washington, United States
    • Spoke 2: Interview, Qualitative Analysis, and Item Development Techniques
      Ashley F. Slagle, PhD, MS
      Endpoints Reviewer, Study Endpoints and Labeling Development, CDER
      FDA, United States
    • Spoke 2: Interview, Qualitative Analysis, and Item Development Techniques
      James P. Stansbury, PhD, MPH
      Social Science Analyst, Division of Non-Prescription Clinical Evaluation, CDER
      FDA, United States
  • 10:15AM - 10:30AM

    Refreshment Break
  • 10:30AM - 11:45AM

    Spoke 2: Interview, Qualitative Analysis, and Item Development Techniques (continued)

    Speaker(s):

    • Spoke 2: Interview, Qualitative Analysis, and Item Development Techniques (continued)
      Ashley F. Slagle, PhD, MS
      Endpoints Reviewer, Study Endpoints and Labeling Development, CDER
      FDA, United States
    • Spoke 2: Interview, Qualitative Analysis, and Item Development Techniques (continued)
      James P. Stansbury, PhD, MPH
      Social Science Analyst, Division of Non-Prescription Clinical Evaluation, CDER
      FDA, United States
    • Panel Discussion Moderator
      Elektra Johanna Papadopoulos, MD, MPH
      Medical Officer, Study Endpoints Labeling Development, CDER
      FDA, United States
    • Panelists
      Ashley F. Slagle, PhD, MS
      Endpoints Reviewer, Study Endpoints and Labeling Development, CDER
      FDA, United States
    • James P. Stansbury, PhD, MPH
      Social Science Analyst, Division of Non-Prescription Clinical Evaluation, CDER
      FDA, United States
    • Cynthia Bens
      VP, Public Policy, Accelerate Cure/Treatments for Alzheimer's Disease (ACT-AD)
      Alliance for Aging Research, United States
    • Donald L Patrick, PhD, MPH
      Professor, Health Services, School of Public Health
      University of Washington, United States
  • 11:45AM - 12:45PM

    Lunch
  • 12:45PM - 2:15PM

    Confirming Content Validity: Finalizing a Measure With an Interpretable Score


    Session Chair(s):

    • Jessica Voqui, PharmD, MS
      Regulatory Review Officer, Study Endpoints and Labeling Development, CDER
      FDA, United States

    The afternoon session builds from the basis of the well-conceptualized draft instrument, looking at methods for finalizing a clinically meaningful instrument that provides interpretable measurement in a specific context of use. The session focuses on exploratory use of mixed methods that incorporate quantification to refine meaning and content.

    Speaker(s):

    • Spoke 2 (continued)
      Jeremy Hobart, PhD, FRCP
      Professor, Clinical Neurology and Health Measurement
      Peninsula College of Medicine and Dentistry, United Kingdom
    • Panel Discussion Moderator
      Jessica Voqui, PharmD, MS
      Regulatory Review Officer, Study Endpoints and Labeling Development, CDER
      FDA, United States
    • Panelists
      Jeremy Hobart, PhD, FRCP
      Professor, Clinical Neurology and Health Measurement
      Peninsula College of Medicine and Dentistry, United Kingdom
    • Ashley F. Slagle, PhD, MS
      Endpoints Reviewer, Study Endpoints and Labeling Development, CDER
      FDA, United States
    • James P. Stansbury, PhD, MPH
      Social Science Analyst, Division of Non-Prescription Clinical Evaluation, CDER
      FDA, United States
    • Cynthia Bens
      VP, Public Policy, Accelerate Cure/Treatments for Alzheimer's Disease (ACT-AD)
      Alliance for Aging Research, United States
  • 2:15PM - 2:30PM

    Refreshment Break
  • 2:30PM - 3:45PM

    Spoke 3 and 4: Completing the Dossier: Reliability, Construct Validity, Ability to Detect Change, and Interpretation Metrics


    Session Chair(s):

    • Paivi Miskala, PhD
      Endpoints Reviewer, Study Endpoints and Labeling Development, CDER
      FDA, United States

    After content validity is demonstrated, other measurement properties specific to the context of use, need to be demonstrated. This session is dedicated to research methods for identifying the other measurement properties—reliability, construct validity, and the ability to detect change. In addition the metrics of clinically meaningful change in the particular context of use will be discussed.

    Speaker(s):

    • Practical Consideration when Planning the Evaluation of Measurement Properties
      Patrick Marquis, MD, PhD, MBA, FACP
      President
      Two Legs Consulting LLC, United States
    • Longitudinal Psychometric Evaluation
      Laura Lee Johnson, PhD
      Statistician, National Center for Complementary & Alternative Medicine (NCCAM)
      National Institutes of Health (NIH), United States
    • Interpretation of Scores
      Lisa A. Kammerman, PhD, MS
      Senior Principal Scientist
      AstraZeneca, United States
    • Panel Discussion Moderator
      Paivi Miskala, PhD
      Endpoints Reviewer, Study Endpoints and Labeling Development, CDER
      FDA, United States
    • Panel Discussion
      Cynthia Bens
      VP, Public Policy, Accelerate Cure/Treatments for Alzheimer's Disease (ACT-AD)
      Alliance for Aging Research, United States
    • Jeremy Hobart, PhD, FRCP
      Professor, Clinical Neurology and Health Measurement
      Peninsula College of Medicine and Dentistry, United Kingdom
    • Laura Lee Johnson, PhD
      Statistician, National Center for Complementary & Alternative Medicine (NCCAM)
      National Institutes of Health (NIH), United States
    • Lisa A. Kammerman, PhD, MS
      Senior Principal Scientist
      AstraZeneca, United States
    • Patrick Marquis, MD, PhD, MBA, FACP
      President
      Two Legs Consulting LLC, United States
    • Elektra Johanna Papadopoulos, MD, MPH
      Medical Officer, Study Endpoints Labeling Development, CDER
      FDA, United States
  • 3:45PM - 4:00PM

    Wrap Up and Adjournment

    Speaker(s):

    • Elektra Johanna Papadopoulos, MD, MPH
      Medical Officer, Study Endpoints Labeling Development, CDER
      FDA, United States

Exhibits  

The Beginning with the End in Mind - Study Endpoints meeting offers interested companies the opportunity to exhibit with a tabletop display.

Tabletop Fee: $1,500

Fee Includes:

  • One six-foot skirted table
  • One chair
  • Standard electricity

Each tabletop rental requires at least one registered attendee to staff the table. All tabletop staff must be registered conference attendees.

Tabletop Exhibit Dates:
March 18-20, 2014

Useful Links:

  • PHT Corporation

Registration Fees 

Member

Member Academia
$895.00
Member Government
$715.00
Member Standard
$1785.00

Non-Member

NonMember Academia
$1120.00
NonMember Government
$940.00
NonMember Standard
$2010.00
Group Discounts

Printable Registration Form

Group Discount

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. 

To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants and include the names of all other group registrants in the Group Discount section. 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

 

Register Online

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.

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