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Advancing Use of Patient-Reported Outcomes
05/16/2019
 

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.


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