Skip to main content
SpringerLink
Log in

Patient Experience Data for Medical Product Development: Opportunity Beyond Obligation

  • Commentary
  • Published:
The Patient - Patient-Centered Outcomes Research Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. Chalasani M, Vaidya P, Mullin T. Enhancing the incorporation of the patient’s voice in drug development and evaluation. Res Involv Engagem. 2018;4:10. https://doi.org/10.1186/s40900-018-0093-3.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Lowe MM, Blaser DA, Cone L, Arcona S, Ko J, Sasane R, et al. Increasing patient involvement in drug development. Value Health. 2016;19(6):869–78. https://doi.org/10.1016/j.jval.2016.04.009.

    Article  PubMed  Google Scholar 

  3. Eastern Research Group Inc. Assessment of the use of patient experience data in regulatory decision-making (final report). June 18, 2021. Available at: https://www.fda.gov/media/150405/download.

  4. Kieffer CM, Miller AR, Chacko B, Robertson AS. FDA reported use of patient experience data in 2018 drug approvals. Ther Innov Regul Sci. 2019. https://doi.org/10.1177/2168479019871519.

    Article  PubMed  Google Scholar 

  5. Nash B, Mowry S, McQueen B, Longman R. People with MS value therapies differently than do physicians or payers (White Paper). 2017. Available at: https://realendpoints.com/wp-content/uploads/2017/12/PhRMA-white-paper-final.pdf.

  6. Contesse MG, Valentine JE, Wall TE, Leffler MG. The case for the use of patient and caregiver perception of change assessments in rare disease clinical trials: a methodologic overview. Adv Ther. 2019;36(5):997–1010. https://doi.org/10.1007/s12325-019-00920-x.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Janssens R, Huys I, van Overbeeke E, Whichello C, Harding S, Kubler J, et al. Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review. BMC Med Inform Decis Mak. 2019;19(1):189. https://doi.org/10.1186/s12911-019-0875-z.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Collison KA, Patel P, Preece AF, Stanford RH, Sharma RK, Feldman G. A randomized clinical trial comparing the ELLIPTA and handihaler dry powder inhalers in patients with COPD: inhaler-specific attributes and overall patient preference. COPD. 2018;15(1):46–50. https://doi.org/10.1080/15412555.2017.1400000.

    Article  PubMed  Google Scholar 

  9. Sarri G, Freitag A, Szegvari B, Mountian I, Brixner D, Bertelsen N, et al. The role of patient experience in the value assessment of complex technologies—do HTA bodies need to reconsider how value is assessed? Health Policy. 2021;125(5):593–601. https://doi.org/10.1016/j.healthpol.2021.03.006.

    Article  PubMed  Google Scholar 

  10. Manzaneque NN, Perez-Arechaederra D, Montalban JMC. Side effects and practices to improve management of type 2 diabetes mellitus from the viewpoint of patient experience and health care management. A narrative review. Endocrinologia Diabetes Y Nutricion. 2019;66(10):596–610. https://doi.org/10.1016/j.endinu.2019.05.010.

    Article  Google Scholar 

  11. Gressel GM, Dioun SM, Richley M, Lounsbury DW, Rapkin BD, Isani S, et al. Utilizing the Patient Reported Outcomes Measurement Information System (PROMIS (R)) to increase referral to ancillary support services for severely symptomatic patients with gynecologic cancer. Gynecol Oncol. 2019;152(3):509–13. https://doi.org/10.1016/j.ygyno.2018.10.042.

    Article  PubMed  Google Scholar 

  12. European Medicines Agency. EMA Regulatory Science to 2025: Strategic reflection. 2020. Available at: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf.

  13. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Proposed ICH guideline work to advance patient focused drug development. 2021. Available at: https://admin.ich.org/sites/default/files/2021-06/ICH_ReflectionPaper_PFDD_FinalRevisedPostConsultation_2021_0602.pdf.

Download references

Ackowledgements

Sincere thanks to Lindsey Norcrossof RTi-Hs for her assistance with background research and editorial support. In addition, thank you to my acknowledgeable & experienced colleagues for their review of drafts, as well as their thoughtful suggestions and comments.

Author information

Authors and Affiliations

  1. Patient-Centered Outcomes Research, HEOR, AbbVie, 5 Giralda Farms, Madison, NJ, 07960, USA

    Robyn T. Carson

Authors
  1. Robyn T. Carson
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Robyn T. Carson.

Ethics declarations

Conflicts of interest

Robyn T. Carson is an employee of AbbVie, Inc and owns stock/stockoptions in AbbVie, Inc.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Carson, R.T. Patient Experience Data for Medical Product Development: Opportunity Beyond Obligation. Patient 15, 147–149 (2022). https://doi.org/10.1007/s40271-021-00570-8

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40271-021-00570-8

Search

Navigation