SOURCE: Cutting Edge Information

Cutting Edge Information

February 17, 2016 08:30 ET

Patient-Reported Outcomes Now Used in Clinical Trials at Majority of Life Sciences Companies, According to Cutting Edge Information

Self-reported measures add to product value propositions

RESEARCH TRIANGLE PARK, NC --(Marketwired - February 17, 2016) - As acceptance for patient-reported outcomes (PROs) grows among regulatory agencies worldwide, life science organizations look to these self-reported measures to round out clinical trials. According to primary intelligence provider Cutting Edge Information, an average 66 percent of surveyed companies report implementing PRO measurements during clinical trials.

These patient-reported endpoints add to product value propositions as companies move through regulatory approval discussions and then pricing and reimbursement negotiations. Although PROs have not been highly popular in the last two decades, 68 percent of clinical trials at surveyed Top 10 companies, 45 percent at surveyed Top 50 and 90 percent at surveyed small pharmaceutical companies now implement these self-reported measures.

"While companies increasingly accept and embrace the value of the patient voice in clinical trials, teams can choose from a number of endpoints as they develop PRO instruments," said Victoria Cavicchi, senior research analyst at Cutting Edge Information. "Among surveyed companies, the majority report using eight metrics during clinical trials."

Key patient-reported metrics range from self-reported signs and symptoms to patient satisfaction levels to reports and ratings of healthcare. Each of these metrics is useful in its own right and can be a best-fit depending on the purpose of proposed clinical trials. 

A recent study by Cutting Edge Information, "Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement," found at provides insights and metrics, collected through primary research that life sciences 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
  • Examine PROs' ability to achieve key study goals in four therapeutic areas: CNS, respiratory, immunology and oncology
  • Understand emerging topics and trends in the PRO space, including the rise of ePRO technology and its impact on data quality

For more information about the latest research on "Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement," please visit

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