Patient-Reported Outcomes

Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement

Patient-Reported Outcomes


This report details PRO teams, budgets, contributions to clinical goals, PRO delivery mechanisms and the future of PROs. Use these findings to begin PRO planning early in the product lifecycle while focusing on data quality and labeling impact. Benchmarks show PRO team size, budget management and average cost per patient, among many other data points, and timelines outline planning, administration and data retrieval. Explore guidelines for optimizing PROs’ impact on regulatory discussions and data effectiveness, and read insights into electronic PROs as well as various PRO delivery mechanisms, from pen-and-paper to tablets and digital media.

  • Description
  • Additional information



Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement

  • Publication Date: July 2014
  • Pages: 131
  • Chapters: 5
  • Metrics: 500+
  • Charts/Graphics: 75

Data includes Benchmarks for PRO team:

  • Structure
  • Team size
  • Budget Management
  • Average Cost Per Patient

Data by company size:

  • Top 10
  • Top 50
  • Small pharma

Data by therapeutic areas:

  • CNS
  • Pain
  • Oncology
  • Respiratory
  • Immunology
  • Infectious Diseases
  • Pediatrics

Primary Audience:

  • Clinical Operations
  • HEOR
  • Medical Affairs
  • Market Access
Report Features

Focus on data quality for PRO endpoints to impact final product labels. Clinical teams have collected patient-reported data for some time. However, this data was not used to its full potential until regulatory agencies in the US and EU released guidances on PRO usage in 2006. Companies are now better able to harness clinical trial PRO data during regulatory and reimbursement conversations. Ultimately, PRO teams hope to provide regulatory agencies with data that will enhance final product labels and better their own marketing strategies. This report showcases how regulatory bodies perceive PROs as well as surveyed companies’ success rates in impacting final product labels via these findings.

Reason to Buy

Leverage a dedicated PRO team to ensure strategic focus and regulatory compliance. As patient-reported outcomes become more important to the clinical development process and market access initiatives, companies should establish dedicated PRO teams. Though these teams are new to the industry, many pharmaceutical organizations recognize the potential benefits of these dedicated groups. This report highlights PRO team structures and resources, as well as provides a look at their growing impact within the organization.

Target Audience

Executives with the following titles are just part of the primary audience for this study:
– Director of PROs
– PRO Manager
– Director of Health Outcomes
– Director of HEOR
– Manager of Global Pricing and Market Access
– Head of Pharmacoeconomics
– Head of Clinical Operations
– Medical Outcomes Specialist

Chapter Example

Patient-reported outcomes (PROs) offer clinical teams and regulatory agencies a more complete look at a drug’s effects and future success. Physiological effects are of course essential — if the drug is not producing the desired medical effect, there is no use in continuing the clinical trial. But PROs offer an additional look at the drug’s impact. In an era of increasing competition and rising payer demands, capturing these results directly from the patient is crucial. Adding the “patient’s voice” to the value proposition positions the product well come approval and reimbursement discussions.

Companies generally discount the value of these self-reported health outcomes in favor of quantitative clinical results. But PROs serve as an important indicator of the drug’s potential for future success: however well the product may perform clinically, a patient will be reluctant to comply with a regimen that is difficult to follow or that negatively impacts his or her quality of life. Non-adherence is estimated to cost the US healthcare system up to $289 billion each year, so payers are looking for these patient data when comparing drugs for formulary position. Companies must thus incorporate these data points starting in early clinical development to best incorporate these endpoints.