Patient-Reported Outcomes

$4,895.00

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.

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Top Reasons to Read This Patient-Reported Outcomes Report

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.

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.

Adopt ePRO technology to maximize PRO efficiency:Patient-reported outcomes delivery mechanisms are key to PRO strategy. Traditionally, PRO instruments have been pen-and-paper or telephone-based.  However, with growing digital technology, the use of electronic patient-reported outcomes (ePROs) is becoming a viable and efficient solution.  This report examines how innovative pharmaceutical companies utilize advanced ePRO instruments to collect patient-reported data more accurately and efficiently. Data also show the percentage of companies using specific PRO modalities, as well as how long companies have had ePRO technology in place.

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Key Questions This Study Answers About Patient-Reported Outcomes

  1. What advantages do companies gain from ePRO technology?
  2. What criteria or processes do teams develop to find best-fit PRO tools?
  3. How successful are these PROs in supporting quality of life and/or cost-effectiveness arguments?
  4. What strategies should teams employ to facilitate a smooth label claim approval process?
  5. What is the average cost per patient for PROs in specific therapeutic areas?

Price $4,895
Publication Date July 2014
Pages 131
Chapters 5
Metrics 500 +
Charts / Graphics 75