SOURCE: Cutting Edge Information

Cutting Edge Information

June 24, 2015 10:00 ET

59% of Companies Begin Planning Their Patient-Reported Outcomes Strategies at Phase 2, According to Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwired - June 24, 2015) - A recent benchmarking study of life sciences companies' patient-reported outcomes (PRO) activities found that 59% of companies begin planning PRO strategies during Phase 2.

"Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement," published by pharmaceutical intelligence provider Cutting Edge Information, found that regulatory agencies strongly encourage companies to begin PRO planning and administration early in the product lifecycles. Though 29% of companies take that advice to heart and begin during Phase 1, the majority of surveyed life sciences firms don't begin until Phase 2.

One interviewed Top 10 pharmaceutical executive explained that her PRO team begins developing PRO endpoints and measures as soon as possible. For PROs to be useful in the ever-important Phase 3 clinical trials -- and eventually appear on final product labels -- the FDA or EMA must approve PRO measures and endpoints. Early approval and implementation are key as companies leverage PRO findings to drive commercial success.

"Ideally, companies want their PRO activities to start early and develop the right endpoints as part of their proof of concept," said Victoria Cavicchi, research analyst at Cutting Edge Information. "Sometimes these activities start before Phase 1. But by Phase 2a, some companies are already testing those measures."

Early planning allows teams to gauge what types of PRO measures they may need, which internal teams will be impacted by the initiative and its findings, and the level of outsourcing required to execute the project. Although PRO planning most frequently takes place during Phase 2, some drug companies wait until Phase 3a to begin administering PRO tactics.

"Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement," available at http://www.cuttingedgeinfo.com/research/market-access/patient-reported-outcomes/, provides insights and metrics, collected through primary research, that patient-reported outcomes executives can leverage to:

  • Add PRO endpoints and measurements into clinical trials to add value to drug dossiers/payer discussions;
  • Develop and standardize in-house PRO development and implementation practices;
  • Determine best-fit PRO measurements as well as decide how many to use and how to leverage them in regulatory and reimbursement discussions;
  • Build and allocate resources to dedicated PRO teams; and
  • Understand emerging topics and trends in the PRO space, including the rise of ePRO technology and its impact on data quality.

To learn more about Cutting Edge Information's patient-reported outcomes research, please visit http://cuttingedgeinfo.com/.

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