Subscriber Sign In
FDA Calendar
Archived Daily Updates
FDA Whistleblower
What do you think?
Search our 64,388-story database
Renew subscription

E-mail This to a Friend | Print Format  
Advancing Use of Patient-Reported Outcomes

Three researchers say effort needs to be increased to incorporate patient-reported outcomes (PROs) as a data source for real-world evidence. Writing online in the journal Nature Reviews Drug Discovery, the researchers say that as pressures from legislation, international regulatory authorities, and patient groups promote more patient-centric drug development and evidence generation, attention is turning to the role of PROs to provide the patient perspective in real-world data sets.

The article looks at some of the current challenges in PRO real-world evidence and gives the researchers’ vision and strategic priorities. Priorities, it says, are: 

  •          ensuring international collaboration across stakeholders including patients, caregivers, clinicians, regulators, ethicists, industry, payers, and policymakers to agree to a standardized approach to PRO assessment;
  •          developing a comprehensive standard set of recommendations, methods, and tools applicable to generation of real-world evidence based on PROs in different settings;
  •          formulating a clear governance process for generation of real-world evidence based on PROs;
  •          establishing standard sets of PRO measures, electronic tools, and administration schedules to raise the bar;
  •          developing and using electronic PROs wherever possible;
  •          minimizing workload and technical complexity for patients, clinicians, and health providers;
  •          carefully considering the objectives of PRO assessment and their timing;
  •          ensuring data collection is findable, accessible, interoperable, and reusable;
  •          providing guidance on how to interpret and use the data; and
  •          ensuring patients and clinicians gain value from assessment through real-time access to PRO data to tailor care to individual needs.

Post an instant comment on this report here

Any copying or electronic transfer without written permission is strictly prohibited and will result
in termination of service and prosecution under the federal Copyright Act.
To gain permission to copy this article log on to http://www.copyright.com.

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com