RESEARCH TRIANGLE PARK, NC--(Marketwired - November 11, 2014) - The pharma industry is more readily considering patient-reported outcomes to enhance marketing strategy. However, regulatory agencies accept, on average, less than one-quarter (22%) of PRO endpoints from pharma companies' clinical trials for final product labeling, finds Cutting Edge Information research.

A recently published study, "Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement," found that although pharmaceutical organizations are embracing PROs, regulatory agencies do not accept all endpoints for final product labels. Individual drug makers surveyed reported a range from 0% of PRO endpoints up to 55% of endpoints appeared on final labels.

Factors both internal and external to a drug manufacturer influence the likelihood of PRO acceptance on the final product label. "Some countries and regulatory bodies -- and even specific departments -- are more comfortable with these types of endpoints than others," explained Victoria Cavicchi, research analyst at Cutting Edge Information. "This familiarity impacts the likelihood that agencies approve PRO endpoints to support label claims."

A drug's therapeutic area also impacts the acceptance of PRO endpoints for label claims. Cutting Edge Information found that pain management studies were most successful, with an average 38% of PRO endpoints approved.

Selecting the best-fit PRO instrument is key to improve the likelihood of endpoints reaching the final product label. Many regulatory agencies are most comfortable with established instruments, such as the SF-36 version 2 and EQ-5D. Researchers should also be prepared to provide multiple PRO data points and be able to replicate findings across multiple trials.

"Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement" ( highlights current industry trends on PRO adoption, strategy and implementation as well as the impact of PRO findings in regulatory and reimbursement discussions.

Patient-reported outcomes, pharmaceutical market access and clinical operations teams have used this benchmarking study to:

  • Implement best-fit PRO measurements into clinical trials to add value to drug dossiers and payer discussions.
  • Build and resource dedicated PRO teams to ensure strategic focus and regulatory compliance.
  • Evaluate the benefits of various PRO delivery mechanisms, spanning traditional pen-and-paper methods to tablets and other digital media.
  • Optimize the impact of PRO findings on regulatory discussions and data effectiveness.

For more information about patient-reported outcomes benchmarks, contact Elio Evangelista at 919-403-6583.

Contact Information:

Elio Evangelista