Increasing Patient Involvement in Drug Development

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 patie...

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Vydáno v:Value in health Ročník 19; číslo 6; s. 869 - 878
Hlavní autoři: Lowe, Maria M., Blaser, David A., Cone, Lisa, Arcona, Steve, Ko, John, Sasane, Rahul, Wicks, Paul
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States Elsevier Inc 01.09.2016
Témata:
Biomedical Research
decision making
drug development
Drug Discovery
Health Services Needs and Demand
Humans
Internal Medicine
Interviews as Topic
methodology
Patient Participation
patient-centered
Qualitative Research
patient-centered
drug development
methodology
decision making
ISSN:1098-3015, 1524-4733, 1524-4733
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Shrnutí: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. To gain a better understanding of the present state of patient involvement in drug development. 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. 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. 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.
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ISSN:1098-3015
1524-4733
1524-4733
DOI:10.1016/j.jval.2016.04.009