The RxView Blog

Real world data, analytics, and insights for healthcare decision makers

Advera Health Analytics, Inc.

Dear FDA, There is No Single Truth Standard

By Jim Davis on September 29, 2017
FDA needs to think of itself as an information curator, rather than an arbiter of information, FDA Commissioner Scott Gottlieb told attendees of the National Academy of Sciences’ workshop on the impact of real-world evidence ( RWE) on Tuesday, September 19th. Further stating, where a single truth standard is secured to a fixed orthodoxy”. 
If only it were that easy. 
A single truth standard sounds great in a world where patients are homogeneous, human biology is fully understood, and motivated trial sponsors don’t design studies to hit specific goals. 
Read More

Topics: FDA, Real World Evidence

How Information on Health Care’s Value is Currently Shared

By Jim Davis on August 9, 2016

On August 1, 2016, Dan Leonard, the President of the National Pharmaceutical Council published an opinion piece for Morning Consult, laying out his reasons for FDA to provide guidance on how biopharmaceutical companies can utilize and share real-world evidence with healthcare decision makers. He argues that due to shortcomings and ambiguities in existing laws, the exchange of information is limited, and stakeholders are making decisions without access to all of the pertinent information.  His solution is more regulation and guidance from FDA.

Read More

Topics: Real World Evidence, Evidex

How Will You Review All 60 drugs up for Approval in 2016?

By Jim Davis on March 18, 2016

It was a big week for us here at Advera Health. On Tuesday we released Evidex™, the next generation of our drug informatics platform that combines annotated data from curated clinical trial results together with structured real world evidence. We are extremely excited about Evidex, as it provides the first end-to-end solution that greatly increases the speed and efficiency of drug reviews by our clients.

Read More

Topics: Clinical Evidence, Real World Evidence, Evidex

5 Steps to Forming a Consensus to Mitigate Adverse Events

By Jim Davis on February 19, 2016

If you are a regular reader of the RxView blog, you are a drug safety advocate. Most likely though, not everyone else in your organization is as safety focused as you, understands the magnitude of safety issues, or understands how to address those issues.

Read More

Topics: Real World Evidence

A Quest for Evidence

By Brian Overstreet on February 12, 2016

This week marks the sixth anniversary of the date that Bob Kyle, Henry Duong, and I incorporated Advera Health Analytics.  We started this journey with a mission to improve patient outcomes by making drug safety data more accessible and actionable.  We spent the early years developing our technologies, building our data delivery platform, and subjecting our early methodologies to peer review.  Two years ago we began to commercialize our enterprise data product and since then we’ve grown exponentially.

Read More

Topics: Clinical Evidence, Real World Evidence, Drug / Indication Information

New call-to-action