1. PCORI Blog: On Contracts: Submitting a Responsive Application, click here for the full post.
2. The Pink Sheet: People in the News: PCORI Advisory Groups, click here for the full article.
3. The Pink Sheet Daily: FDA's Temple Pushes Feasibility, Cost-Savings of Large, Simple Trials, click here for the full article, (paid subscription required)
4. The American Prospect: The Most Expensive Health Care in the World, click here for the full article.
This past week’s PCORI blog was penned by James Hulbert, Scott Solomon, Kara Odom Walker, and Tsahai Tafari. In it they comment that, “Among the 356 applications in the Winter 2014 Cycle, almost 10 percent were not considered for Merit Review because they did not comply with either programmatic or administrative considerations. The three most common reasons for disqualification…were: Didn't include comparative effectiveness research (CER); Contained cost-effectiveness analysis (CEA); Didn't comply with administrative requirements (e.g., exceeded page limits, budget limits, or period of performance).” Click here to view the full post.
2. The Pink Sheet: People In the News: PCORI Advisory Groups
The Pink Sheet reported last week about the latest named advisory group for the Patient-Centered Outcomes Research Institute. “PCORI's Advisory Group on Rare Diseases' first roster includes Amgen Inc. Senior Manager, Global Health Economics James Wu, National Organization for Rare Disorders Senior VP, Medical and Scientific Affairs J. Russell Teagarden, Shire Pharmaceuticals Director, Global Market Access Philip Ruff and NIH National Center for Advancing Translational Sciences Office for Rare Disease Research Program Director Yaffa Rubinstein.” Click here to view the full article (subscription only).
3. The Pink Sheet: FDA's Temple Pushes Feasibility, Cost-Savings of Large, Simple Trials
Sarah Karlin of The Pink Sheets Daily reports on comparative effectiveness research within the scope of the size of drug trials for rare diseases. “[B]ecause treatment effect sizes in chronic conditions are usually modest, determining the long-term, benefit-risk profile often requires large numbers of clinical events in representative populations, [FDA's Robert Temple, along with Zubin Eapen, Duke Clinical Research Institute, and Michael Lauer, National Heart, Lung and Blood Institute] writes. This is particularly true in comparative effectiveness trials and for trials of drugs looking to show advancement over a standard-of-care.” Click here to view the blog post (paid subscription required).
4. The American Prospect: The Most Expensive Health Care in the World
In an op-ed last week, Paul Waldman of The American Prospect commented, “[A]s we've been debating health care over the past five years, every time someone has proposed ways to get a handle on some of these costs, like conducting comparative effectiveness research to determine which treatments really work and are worth their cost, Republicans have cried ‘Rationing! Death panels!’ And then they turn around in almost the same breath and say Medicare's costs are out of control so we have to turn it into a voucher program and cut benefits.” Click here to view the article.