Comparative Effectiveness Research Helps Improve Patient Outcomes
(6/5, Nick Klenske, Radiological Society of North America) reports “...‘CER entails comparisons whenever there is more than one management approach available and there are questions about which one yields better outcomes of interest,’ said Stella Kang, MD, a radiologist at the NYU School of Medicine. ‘Performing a head-to-head comparison of two or more available strategies is the most direct way of identifying the most effective diagnostic tests or treatment.’” Full
FDA 'Open for Business' in Considering Real-World Evidence, Sharpless Says
(6/5, Kim Dixon, Biopharma DIVE) reports “The [FDA] is ‘open for business’ in considering real-world evidence to clear expanded uses of new cancer drugs, acting agency head Ned Sharpless said Tuesday, but warned industry against relying too heavily on alternative sources of data. Speaking at the BIO conference in Philadelphia, the former National Cancer Institute director acknowledged the rising cost and complexity of clinical trials, and indicated the FDA is aware of how difficult enrolling studies of rare disease subtypes can be.” Full
Closing Gaps in Real-World Evidence through Data Linkage
(6/5, tHEORetically Speaking) comments “Dr. Patti Peeples, CEO of HealthEconomics.Com, sat down with Dr. Kevin Haynes, Principal Scientist at HealthCore-NERI, to discuss closing gaps in real-world evidence through data linkage. The mission of HealthCore-NERI is to provide clarity that empowers decision makers to act with precision to improve quality, safety, and affordability in health care. HealthCore-NERI works with life science companies, payers and providers, and government and academic organizations to provide real-world evidence in support of a wide variety of health care decisions.” Full
How to Apply Real-World Evidence to Outsmart Cancer
(6/4, Christopher Boone and Viraj Narayanan, STAT Plus) comments “...Life science companies need to build in skilled real-world evidence translators who can work between clinical trial teams and real world evidence companies. Take, for example, the case of creating an external real-world evidence comparator arm for a clinical trial. Doing this requires careful matching of real-world data elements to the clinical trial protocol. This includes identifying the correct inclusion and exclusion criteria, identifying the appropriate real-world evidence data elements to incorporate, and specifying the appropriate measurable endpoints.” Paid Subscription Required
First STAT Summit To Convene Health Care Leaders In Cambridge, Mass.
(6/4, STAT Press Release) “...The two-day summit will bring together top biotech, pharma, and life sciences executives and researchers, health care policymakers, and patient advocates to discuss the hopes and pitfalls involved in the creation of new treatments. The goal: to set the agenda for the future of medicine...The inaugural STAT Summit is launching with a variety of industry-leading companies and organizations as sponsors...The National Pharmaceutical Council is a Supporting Sponsor.” Full
Health Technology Assessment as Part of a Broader Process for Priority Setting and Resource Allocation
Mitton C, et al.
June 3, 2019, Applied Health Economics and Health Policy
A Randomised Controlled Trial Assessing the Use of Citalopram, Sertraline, Fluoxetine and Mirtazapine in Preventing Relapse in Primary Care Patients Who Are Taking Long-Term Maintenance Antidepressants (ANTLER: ANTidepressants to prevent reLapse in dEpRession): Study Protocol for a Randomised Controlled Trial
Duffy L, et al.
June 3, 2019, Trials
Navigating Joint HTA, Procurement, and Fair Pricing: Evidence-Based Insights and Practical Recommendations - A Meeting Report from ISPOR Regional Conference in Warsaw, 2019
Inotai A, et al.
June 4, 2019, Expert Review of Pharmacoeconomics & Outcomes Research