Patient reported outcomes to support drug development decision making

Authors

  • Annabel Nixon Chilli Consultancy, UK
  • Diane Wild Independent PRO and linguistic validation consultant, UK
  • Willie Muehlhausen ICON plc, UK

DOI:

https://doi.org/10.7175/fe.v16i2.1187

Keywords:

Patient reported outcomes, Health related quality of life, Endpoint

References

FDA (Food and Drug Administration). Guidance of Industry. Patient-reported outcome measures: use in medical product development to support labeling claims. December, 2009. Available at http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf

Gnanasakthy A, Mordin M, Clark M, et al. A review of patient-reported outcome labels in the United States: 2006 to 2010. Value in Health 2012: 15: 437-42; http://dx.doi.org/10.1016/j.jval.2011.11.032

DeMuro C, Clark M, Doward L, et al. Assessment of PRO label claims granted by the FDA as compared to the EMA (2006-2010). Value in Health 2013: 16: 1150-5; http://dx.doi.org/10.1016/j.jval.2013.08.2293

Tse J, Shingler S, Nixon A. The emerging role of patient-reported outcomes (PROs) in FDA hematology and oncology product labels. Value in Health 2015; 18: A210; http://dx.doi.org/10.1016/j.jval.2015.03.1216

Basch E, Geoghegan C, Coons SJ, et al. Patient-reported outcomes in cancer drug development. Perspectives from industry, the Food and Drug Administration, and the patient. JAMA Oncol 2015; 1: 375-9; http://dx.doi.org/10.1001/jamaoncol.2015.0530

Dimopoulos MA, Delforge M, Hajek R, et al. Lenalidomide, melphalan, and prednisone followed by lenalidomide maintenance improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial. Haematologica 2013; 98: 784-8; http://dx.doi.org/10.3324/haematol.2012.074534

Minden MD, Dombret H, Seymour JF, et al. The effect of azacitidine on health-related quality of life (HRQL) in older patients with newly diagnosed acute myeloid leukemia: results from AZA-AML-001 trial. 20th Congress European Hematology Association. Vienna, 2015; Abstract P184

Downloads

Published

2015-06-30

Issue

Vol. 16 No. 2 (2015)

Section

Editorial

License

>> DISTRIBUTION / LICENSE <<

 

Authors who publish with this journal agree to the following terms:

  1. Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
  2. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal. The Publication Agreement can be downloaded here, and should be signed by the Authors and sent to the Publisher when the article has been accepted for publication in this journal.
  3. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (see The Effect of Open Access).
  4. Authors are permitted to post their work online after publication (the article must link to publisher version, in html format)

How to Cite

Patient reported outcomes to support drug development decision making. (2015). Farmeconomia. Health Economics and Therapeutic Pathways, 16(2), 35-37. https://doi.org/10.7175/fe.v16i2.1187