title: Increasing Patient Involvement in Drug Development.
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.
authors.affiliation: PatientsLikeMe, Cambridge, MA, USA. Electronic address: mlowe@patientslikeme.com.
authors.forename: Maria M
authors.initials: MM
authors.lastname: Lowe
authors.affiliation: PatientsLikeMe, Cambridge, MA, USA.
authors.forename: David A
authors.initials: DA
authors.lastname: Blaser
authors.forename: Lisa
authors.initials: L
authors.lastname: Cone
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Steve
authors.initials: S
authors.lastname: Arcona
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: John
authors.initials: J
authors.lastname: Ko
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Rahul
authors.initials: R
authors.lastname: Sasane
authors.affiliation: PatientsLikeMe, Cambridge, MA, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Wicks
mesh_terms: D035843:Biomedical Research; D055808:Drug Discovery; D006301:Health Services Needs and Demand; D006801:Humans; D007407:Interviews as Topic; D010358:Patient Participation; D036301:Qualitative Research
keywords: decision making; drug development; methodology; patient-centered