Abstract:
Background
To ensure the creation of treatments that maximize value at the lowest cost, all aspects of the health care system need to align with patient needs and preferences. Despite growing efforts to engage patients in research and regulatory activities, the pharmaceutical industry has yet to maximize patient involvement in the drug development process.
Objective
To gain a better understanding of the present state of patient involvement in drug development.
Methods
Through a semistructured interview methodology, we sought to identify opportunities, barriers, and examples of patient involvement in the drug development process. Telephone interviews were conducted with six senior leaders of evidence generation within the pharmaceutical industry and four patients. These interviews were supplemented with interviews with a research funder, a regulator, a patient advocacy group, and a caregiver.
Results
Although our interviewees spoke of the potential benefits of aligning research around the needs of patients, there were few examples they could share to suggest this was occurring at scale. A number of barriers were identified including the added burden associated with adverse event reporting, concerns about patient representativeness or their ability to participate in drug development conversations, and the costs in time and resources involved relative to returns on investment.
Conclusions
As health care systems continue to evolve and establish patients as the primary stakeholder in their health care decision making, the pharmaceutical industry will need to be innovative to demonstrate the value of their products relative to the outcomes experienced by patients. Pharmaceutical companies should recognize the value of involving patients across the entire product life cycle and work to transform present perceptions and practices throughout their organizations.
Keywords
decision making; drug development; methodology; patient-centered
Citation: Maria M. Lowe, PharmD, BCPS, David A. Blaser, PharmD, Lisa Cone, BA, Steve Arcona, PhD, John Ko, PharmD, MS, Rahul Sasane, PhD, Paul Wicks, PhD Increasing Patient Involvement In Drug Development doi:10.1016/j.jval.2016.04.009
Availableonline: 24 May 2016
Copyright: © 2016, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).http://dx.doi.org/10.1016/j.jval.2016.04.00
Acknowledgments
We thank the interviewees and patients for their time and leadership in helping us better understand how to incorporate the patient perspective in the development process for new medications.
Source of financial support: This work was funded by Novartis Pharmaceuticals. No restrictions were placed on the design, analysis, or interpretation of the research or on the writing and submission of the manuscript. The views expressed in this publication are those of the authors.
