Drugs

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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome