Author Archive

BIG & A Rapid Learning Network for Children’s Health

October 14, 2008

There are so many possibilities for a BIG Health Consortium that is difficult to figure out where to begin! One of the areas with a lot of need – and potential — to be considered is children’s health. There are large gaps in the clinical evidence base for care of children, since they are usually excluded from randomized clinical trials. Moreover, most pediatric practices are small, which limits the ability to advance research on children’s health issues by using registries and databases. There is a particular scarcity of pediatric databases that included patient genetic data.

Pediatric oncology offers an example of where a national effort to develop collaborative research and share data about nearly all children with cancer has resulted in great advances in clinical outcomes. Another example of successful collaboration in a selected children’s health area is the CDC’s Vaccine Safety Datalink, which draws on databases from eight large HMOs. Recently, Children’s Hospital of Philadelphia has been discussing creating a research network of children’s specialty institutions, many of which use the EPIC software platform. There are many potential participants for a national children’s health network, ranging from large organized systems (like Kaiser-Permanente) to academic health centers and community practices.

BIG Health could be the catalyst to create a data-sharing framework for a comprehensive system for children’s health research.

-Lynn Etheredge

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BIG Health & New Technologies

October 7, 2008

I think there are major opportunities for BIG Health to create a national system to learn as much as possible, as soon as possible, about the best uses of new technologies.

How might BIG Health contribute? Here’s a sketch of what could be done: Early after a new technology is introduced – ideally, the point of FDA approval, or Medicare coverage, of a new drug, device or procedure – HHS (BIG Health, NIH, FDA, AHRQ, and CMS), with the private sector (physician specialty societies, health plans, researchers, biotechnology and device industry) would develop a national research plan that identifies important effectiveness and safety questions to be answered (e.g. over the next three years), specifies the data needed to answer the questions, and blueprints a linked system of clinical registries to gather the data and make it available for research. In this initial period, major public and private insurers would agree to make their payments be contingent on provider reporting of the needed information to the registries.

BIG Health could have a key role in creating this national system: (1) as a convener, within HHS and with outside parties, to identify research questions and resolve the technical issues needed to create the registries and enable sharing of data; and (2) via BIG’s capabilities, to enable the data-sharing and research projects to proceed quickly and smoothly, connecting many interested parties and collaborators. Absent such an initiative, efforts to learn about new technologies will continue to be a huge problem area for everyone. Working with others, BIG Health could pick several new technologies for national demonstrations.

These BIG capabilities would likely have a lot of use. Both the new FDA Sentinel Network legislation to study drug safety (with up to 100 million patients) and pending legislation for a national comparative effectiveness initiative will need a capacity to carry out studies that can access many databases. Even more urgently, physicians and patients need to know quickly if new technologies offer better results for individual patients. And new technologies are a great place to start: by definition they are where we have the most to learn.

-Lynn Etheredge