BazEkon - Biblioteka Główna Uniwersytetu Ekonomicznego w Krakowie

BazEkon home page

Meny główne

Autor
Gokhale Sameer (Epidemiologist at EpiCube Innovations)
Tytuł
Comparator Outcomes Profile: Need for An Informed Assessment of Secondary Outcomes for Conducting Post-Launch Observational Studies in The HE&OR Setting
Źródło
Journal of Health Policy and Outcomes Research, 2015, nr 2, s. 18-22, rys., bibliogr. 9 poz.
Słowa kluczowe
Rynek, Choroby, Badania porównawcze, Służba zdrowia
Market, Illness, Comparative examination, Health service
Uwagi
summ.
Abstrakt
Secondary clinical and health outcomes provide additional value and help drug molecule distinguish itself from competitor molecules. Comparator outcomes profile (COP) document in health economics and outcomes research (HE&OR) setting is designed to understand comparative clinical and health outcomes relevant to molecule's value proposition against select comparators. Generic and disease specific clinical as well as patient reported tools to measure secondary outcomes across geographies are identified from literature and studied to assess their reach and acceptability. Collated summary statistics for key outcomes are presented (tables, figures and listings) by healthcare researchers to help program manager make an informed assessment. COP not only can provide guidance on post-launch observational study design, study endpoint discussion, and indirect comparisons but can also give direction to country organizations in developing their local HE&OR strategy. To conclude, COP can be an important construct in HE&OR setting for molecule's program development activities(original abstract)
Pełny tekst
Pokaż
Bibliografia
Pokaż
  1. Whittington R. Introductions to Health Economics Concepts: A Beginner's Guide. Greenflint Ltd. Flintshire, UK, 2008
  2. Sedgwick P. Primary and secondary outcome measures. BMJ 2010; 340: c1938
  3. Pocock Stuart J. Clinical Trials with Multiple Outcomes: A Statistical Perspective on their Design, Analysis, and Interpretation. Controlled Clin Trials 1997; 18: 530-545
  4. Freemantle N. Interpreting the results of secondary end points and subgroup analyses in clinical trials: should we lock the crazy aunt in the attic? BMJ 2001; 322(7292): 989-991
  5. Cohn JN. Introduction to Surrogate Markers. Circulation 2004; 109 (25 Suppl 1): IV20-1
  6. Velentgas P, Dreyer NA, Nourjah P, et al. Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Jan
  7. Wiebe S. The principles of evidence-based medicine. Cephalalgia. 2000;20 Suppl 2:10-3
  8. Rockhold F, Segreti T. Secondary Efficacy Endpoints in Encyclopedia of Statistical Sciences. John Wiley & Sons, Inc.; 2014
  9. Glenny AM, Altman DG, Song F et al. Indirect comparisons of competing interventions. Health Technol Assess 2005; 9: 1-134, iii-iv
Cytowane przez
Pokaż
ISSN
2299-1247
Język
eng
URI / DOI
http://dx.doi.org/10.7365/JHPOR.2015.2.2
Udostępnij na Facebooku Udostępnij na Twitterze Udostępnij na Google+ Udostępnij na Pinterest Udostępnij na LinkedIn Wyślij znajomemu