What is DARWIN EU?

Real-world data is becoming increasingly important as the amount of data generation increases as does the speed of data processing. In the US, the 21st Century Cures Act was enacted in December 2016 and mandated that the Food and Drug Administration (FDA) create a framework for evaluating the use of real-world data help support the…

Dual Eligibles’ Medicaid Policy Database

Poor, elderly individuals who may qualify for both Medicaid (for being poor) and Medicare (for being elderly, blind, disabled or have ESRD). In these cases, Medicaid serves as a supplemental insurer, covering Medicare coinsurance and deductibles. The generosity of this supplemental coverage for so-called ‘dual-eligibles’ varies across states. These differences in Medicaid payments arise from…

FDA sets standards for Real-World Evidence

The 21st Century Cures Act, enacted December 2016, mandated that the FDA consider how to use real-world evidence (RWE) to bring innovative treatments to market faster. To meet this statutory requirement, the FDA has provided guidance outlining its policies for using RWE to support the approval of a new drug indication. What is real-world evidence?…

Need health care data?

The International Society For Pharmacoeconomics and Outcomes Research (ISPOR) has put together a database of databases from around the world. The ISPOR International Digest of Databases has goal is to organize global health care databases into searchable models.  Their working group on this topic is chaired by Carl Asche and Elisabeth Oehrlein.  If you have…

China fabricates clinical trial data?

Academic integrity is one of the bedrocks upon which research is founded.  With that said, it is with great concern that I came across an article that stated that 80% of Chinese clinical trials data is fabricated.  Science Alert reports: The review looked at data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass…

Cost effectiveness analysis Q&A

What is cost effectiveness analysis or CEA?   One definition is that CEAs–at least in the field of health care–measure the difference or ratio between cost of care and the benefits of care for a given intervention compared to an alternative treatment strategy.  The intervention could be a new surgical procedure, a drug, a behavior modification program or any other…

Increased access to CMS data

The Research Data Assistance Center (ResDAC) has announced that individuals and firms will now be able to get access to more CMS data.  They describe their “Innovator Research” program as follows: Innovators and entrepreneurs may now access CMS data as part of a research study to create products or tools that they intend to sell…