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Jun 15, 2011 (Vol. 31, No. 12)

Classic Medicine Awaits Digital Overhaul

Electronic Records May Reinvent Clinical Trial Operations and Personalized Medicine.

  • Standards

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    23andMe is a retail DNA testing service providing information and tools for consumers to learn about and explore their DNA. The first step is to order a kit from the company (shown). Once the kit is received, it should be registered, and the tube spit into and returned to the lab. A CLIA-certified lab analyzes the DNA in six to eight weeks and then users can start exploring their genomes.

    Realizing the promise of eMRs depends to some extent upon continually developing standards, allowing greater interoperability of data exchange among competing eMR systems. Standards have not yet evolved to make all data portable across systems.

    At GE, “We are increasing our nomenclature and terminology research for our customers as well as making that part of the public domain. We look forward to presenting that to standards organizations,” Dr. Dente notes.

    What, exactly, constitutes an electronic medical record has yet to be determined. “There’s much less debate about what type of information we want to include in the database than about the ramifications of having eMRs,” Dr. Harris says.

    At their most basic, “eMRs are electronic ways of holding data so patients don’t have to fill in forms again. Even having a summary level of information will save the healthcare system time and money.” They also can be much more. “How deep do we want to go?” Dr. Harris asks, pointing out that eMRs could store detailed information, or could link to other sources—such as hospital picture archiving and communication systems (PACS)—for images and test results. “eMRs needn’t contain all the information about an individual,” Dr. Harris says, but they may, in the future, store DNA sequence information.

    For electronic clinical trials, they may be more valuable if they do contain comprehensive, yet de-identified, information. Organizations already access insurers’ databases for information, but an eMR would provide immediacy.

    The PCORI is being formed “to add the patient to the equation. As a cardiologist, I can speak about clinical trial results, but people want to know what’s right for them rather than statistical averages,” Dr. Weisman stresses. PCORI, once operational, will develop systems that provide information in near real time based upon medical conditions and such additional factors as lifestyle and geographic and occupational risks. Eventually, “You (as a patient) will be able to query and get information about people with profiles similar to yours, and what happens to them when they choose different options for prevention, diagnosis, and treatment,” he predicts.

    Organizations like 23andMe and others that provide genetic testing directly to consumers, are filling in some of the information gaps. As Anne Wojcicki, CEO, explains, the information allows patients to tell their physicians they have the markers for particular conditions, but 23andMe doesn’t sequence the genome. “While there’s huge government pressure to put medical record information online, there’s not yet a movement toward including genetic information in electronic medical records.”

  • Probability Analysis

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    According to Siemens’ researchers, adding sequencing information to individuals’ medical files is not enough. A probability analysis based on all the available information, including imaging and blood tests, is essential in order to get a better sense of what is being expressed and what it means to individual patients.

    Making data available electronically is only one part of the challenge, though. “The critical skill is the integration of genotypic and phenotypic information,” stresses Don Rucker, M.D., CMO at Siemens Healthcare USA. The convergence of IT and genomics involves far more than adding gene sequencing information to individuals’ medical files. “The whole nature/nurture boundary is far more confused than anyone thought.” Therefore, for the convergence to have meaning, Dr. Rucker says a probability analysis is vital.

    That analysis must be based upon all the available information—genomics, proteomics, imaging, blood tests, etc.—to develop a better sense of what is being expressed and what it means to individual patients. For example, Dr. Rucker points out that while the presence of the 9p21 gene increases the probability of heart disease to about 50%, a cardiac CT angiogram can now determine the probability of coronary disease to a level of 98% or 99% accuracy.

    “For the pharmaceutical industry, the bad news is that there is more data to sift through. The good news is that there is great confidence about the data and the ability to develop more targeted datasets, potentially lowering clinical trial size,” Dr. Rucker concludes.

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