Archive for the ‘Guest Authors’ Category

Connections Matter

November 21, 2008

There is a developing conversation around “Science 2.0,” where it is argued that the application of social networking platforms that have proven so successful in other contexts can be leveraged to enable and improve scientific collaboration. Tools like blogs, wikis and forums as well as the scientific equivalent of Facebook/MySpace are already being used by members of the scientific community, sometimes with large and enthusiastic communities of participants. The active participation in sites like and Epernicus illustrates that scientists as a group have an interest in social networking, and are willing to make use of such infrastructure when it supports their business/science goals.


It is not enough, though, to build instances of existing tools and expect that the scientific users will flock to them and immediately figure out ways to use the infrastructure to support their work. What is constructed must fit into useful paradigms of scientific activity, and tools must truly reflect the activities and work process of the scientists who would use them. This approach must go beyond the “electronic lab notebook” that has been the dominant paradigm for collaborative systems in science. It requires a close examination of how scientists actually work today, and a reasoned approach to how that work will change in the future. By mindful watching of scientists at work, listening to their concerns and interests, and having a willingness to push the envelope on the existing tools, it will be possible to create novel systems that go beyond simply mimicking the existing processes. It will also be necessary to engage scientists at all levels. Although it is tempting to focus solely on the senior-most researchers, it will be critical to engage younger scientists and those engaged in the more mundane technical activities to create real and lasting value in tools that support research.


I have been involved as a member of the Data Portability Project Healthcare Task Force, and have had the opportunity to see how the standardized and interoperable exchange of data can enable, enhance and support the needs of a widespread scientific community. The Data Portability Project defines itself as “the option to use your personal data between trusted applications and vendors.”  This represents a generalization of what we have been talking about in the BIG Health Consortium™ – namely that providing our participants, whether they are patients, clinical researchers, basic scientists, or physicians the ability to safely and securely share data with their caregivers, colleagues and collaborators is critical in order to move to the next level of translational research and to realize the promise of personalized medicine. Obviously, concerns about privacy, security and safety are important in our health care and health research space, but equally important will be providing a means for those engaged in these activities to access (and control access to) the electronic component of their information. Beyond simply supporting the secure exchange of data, the ability to effectively participate in new and more integrated ways as a part of the scientific research community as a whole can give stakeholders a sense of belonging to the process, which can enable entirely new communities that transcend the traditional divisions between patients, physicians and researchers.   


Our community needs to engage in the development of meaningful new methods for communication and collaboration around our research, and participate in activities like the Data Portability project in order to ensure that the ”voice” of basic science research and translational medicine does not get lost in the broader and more general conversations about storing, accessing and making use of health data. It is my fond hope that the BIG Health Consortium™ and related efforts like caBIG®® will provide us with a community base for these discussions and thus ensure the best possible outcome for our research community, and for the patients whom we ultimately serve.


-Mark Adams, BIG Health Futurist

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