Posts Tagged ‘guest author’

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

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

PCAST and Personalized Medicine

September 18, 2008

Today, the President’s Council of Advisors on Science and Technology (PCAST) presented its report “Priorities for Personalized Medicine.” I recommend that you take a gander at what’s been cookin’ with them.

PCAST is a body appointed by the President comprising the Director of the Office of Science and Technology Policy and members from outside the Federal government with diverse expertise in science, technology, and the impact of science and technology to provide advice on matters of science and technology policy. Kathy Behrens and Floyd Kvamme–the co-chairs of this report–are real icons in the health technologies and private investment world and know the biotechnology space, and most importantly, know how to do the future value scoping of what this all means to health care.

Apparently, this is pretty important to them. They take an outside-in view on three vectors of Personalized Medicine–technology and tools, regulation, and reimbursement for its policy considerations. This report brings under one banner some of the key views of whether yesterday’s health care system can accommodate these new capabilities or whether systems change is needed to enable the value and capabilities of genomics, health IT and evidence-based medicine to reach its pinnacle of opportunity.

Maybe this will be the report that starts the conversation to bring into scope the actions needed across academe, business, and government to enable the full potential of personalized medicine to come into focus. Incremental (accidental?) change vs. a strategic redesign for the application of technology and knowledge is the crossroads we’ve reached. Maybe their work is the fulcrum for deciding who’s onboard for this transformation and who’s happy with the safe and predictable footing we’re on and waiting for others to decide the path forward. Maybe it’s time to raise the stakes. This work by PCAST brings together the major steps to be considered for the value of health care and who’s in and who’s out. Judge for yourself if this is the direction we should go – as a community of the willing.

-Greg Downing, DO, PhD