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ISPOR eBulletin March 2007
The ISPOR eBULLETIN provides updates of recent ISPOR
activities and events. For detailed information on ISPOR activities, members
are encouraged to go to:
www.ispor.org.
Please share these new ISPOR activities with your colleagues.
Value in Health
Volume
10, Issue 3 On-Line Early
Value in Health
Volume 10, Issue 3 is now
available On-Line Early.
Value
in Health >>
ISPOR CONNECTIONS Volume 13, Issue 1 Now On-Line
ISPOR
CONNECTIONS Volume 13, Issue 1 is now available on-line. Featured articles
include: POLICY ANALYSIS: "Reimbursement of Drugs in Germany: A Road Map for the Approval Process," OUTCOMES ASSESSMENT: "A Collaborative
Approach to Patient-Reported Outcome (PRO) Instrument Development: The
EXACT-PRO Initiative," and ECONOMIC EVALUATION: "The Missing Link: Managing
Missing Data in Economic Evaluations".
ISPOR
CONNECTIONS>>
ISPOR Launches THREE NEW Patient Reported Outcomes
Good Research Practices Task Forces
Recently, the FDA issued a draft Guidance for the Industry on Patient-Reported Outcome (PRO) Measures and the EMEA issued a Reflection Paper on the Regulatory Guidance for the Use of Health Related Quality of Life Measures in the Evaluation of Medicinal Products. In comments to the FDA, ISPOR members identified a need for clarity on PRO measurements. The ISPOR Health & Science Policy Council recommended PRO Task Forces on Good Research Practices to address these key issues , which was recently approved by the Board of Directors leading to the development of the following 3 task forces:
PRO: Use of Existing Instruments & Their Modification
Chair: TBD
Objective: Development of good research practices for assessing
existing instruments for use in label claim studies, identifying the concepts
contained in existing instruments, obtaining patient input if not used in
original instrument, development of instruments used in a battery and
modification of these instruments including use in new measurement concept,
use in new population, change in item content, change in mode of
administration, and assessment of measurement properties for revised
instruments.
PRO:
Changing Culture or Language
of Application
Chair:
Diane Wild MSc, Director, Oxford Outcomes
Objective:
Development of good research
practices for adapting or translating an instrument from one language/culture
to another including translation measurement properties and acceptability of
pooling data in multi-language trials.
PRO:
Changing Mode of
Administration/ePRO
Chair:
Stephen J. Coons PhD, Professor
of Pharmacy and Public Health, University of Arizona
Objective:
Development of good research
practices for changing the mode of administration (e.g. paper to computer,
supervised to self questionnaire) and use of electronic PRO instruments.
If you
are interested in joining a PRO task force, please e-mail:
pro@ispor.org.
ISPOR Task
Forces>>
ISPOR Launches NEW Health Care Decisions Using Outcomes Research
SIG
The SIG’s goal is to increase understanding of how health care decisions are made and to increase the use of clinical, economic, and patient reported outcomes research in health care decision-making.
Employer/Insurer Perspective Working Group>>
Hospital Administrator Perspective Working Group>>
Disease/Health Management Working Group>>
Risk Benefit Management Working Group>>
For more information and to join:
Health Care Decisions Using
Outcomes Research SIG (HCDUOR)>>
Journal
of Managed Care Pharmacy
In association
with The Academy of Managed Care Pharmacy (AMCP), ISPOR is happy to provide
access to the Journal of Managed Care Pharmacy (JMCP) to its members.
JMCP
Volume 31, Issue 1 2007 Table of Contents>>
JMCP
Volume 31, Issue 2 2007 Table of Contents>>
** ISPOR WEBSITE TIP **
To view the Pharmacoeconomic
Guidelines Around the World - currently representing 23 countries and 28
guidelines, including 21 PE guidelines, 6 submission guidelines for formulary
listing, and 1 for journal publication - go to:
www.ispor.org
and click the
Pharmacoeconomic Guidelines
Around the World
link under the Tools for Health Care Decision Makers box on the right-hand
side.
This
newsletter is provided as a benefit of membership in ISPOR. If you
received this from a colleague and are not a current ISPOR member,
please
consider
becoming an individual member or organizational affiliate.
Contact
membership services
for more
information and its use in health care decisions.
The International Society for Pharmacoeconomics and
Outcomes Research is an international organization promoting the science of
pharmacoeconomics and health outcomes research.
3100 Princeton Pike, Suite 3E,
Lawrenceville, NJ, 08648 USA
Tel: 609-219-0773 Toll Free:
1-800-992-0643 Fax: 609-219-0774
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