PRO Endpoint Success Rates are Highest for Pain Management Drugs

Companies focus on data quality for patient-reported outcomes endpoints to impact final product label

RESEARCH TRIANGLE PARK, NC--(Marketwired - November 17, 2016) - Out of all the therapeutic areas studied, pain management had the highest average percentage (39%) of patient-reported outcomes (PRO) endpoints shown on a final product label, according to industry research published by Cutting Edge Information. In other therapeutic areas, concrete clinical data may be more readily attained and patient-reported outcomes appear less beneficial.

According to the study, Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement, other therapeutic areas where drug companies observed PRO endpoints include:

  • Oncology
  • Respiratory
  • Immunology
  • Pediatrics
  • Infectious diseases
  • Central Nervous System (CNS)

Following pain management, the next most successful therapeutic area to see PRO endpoints impacting drug labels was oncology (26%), closely followed by respiratory (25%) and immunology (23%).

"Selecting the right PRO instrument is a vital step that influences the likelihood of affecting the final product label," said Adam Bianchi, senior director of research at Cutting Edge Information. "Most regulatory bodies are more comfortable with established instruments, as opposed to a new instrument uniquely designed for a trial."

To lend credibility and weight to patient-reported outcomes data, drug manufacturers should be prepared to offer several PRO data points and replicate the findings across several trials. Transitioning to an electronic system of data capture also helps to ensure data PRO reliability.

Patient-reported outcomes lend clarity to a product's efficacy and incorporate the patient voice into clinical assessments. Although it may be challenging to gain final product label regulatory approval, selecting PRO instruments that are more likely to succeed can impact the commercial success of a product.

Cutting Edge Information's study, Patient-Reported Outcomes: Infusing the Healthcare Consumer Voice into Clinical Development and Reimbursement, available at, provides primary research insights and metrics that life sciences executives have used 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 major therapeutic areas
  • Understand emerging topics and trends in the patient-reported outcomes space, including the rise of ePRO technology and its impact on data quality

For more information about patient-reported outcomes, visit

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Contact Information:


Elio Evangelista
Senior Director of Commercialization
Cutting Edge Information

patient-reported outcomes on product labels