The Marshfield Clinic's Personalized Medicine Research Project was conceived in 2000.76,83 The project was designed to coordinate existing resources of the Clinic that were unique and robust in aggregate. These resources included (1) a 12-year-old epidemiological study area encompassing 80,000 patients who had received their health care at the Clinic for several decades, (2) a highly sophisticated electronic medical record that tracked and integrated the outpatient and inpatient health care events for the Clinic population consisting of over 1.2 million electronic records spanning over 20 years, (3) a data warehouse and provider-initiated lexicons that allowed data retrieval for specific clinical phenotypes, (4) extensive experience in human genotyping through the Center for Medical Genetics that developed the Marshfield Maps used globally for evaluating the genetic basis of disease, and (5) extensive infrastructure and experience in patient recruiting and consenting for over 700 clinical research projects on an annual basis.
Since the population of the Marshfield Epidemiological Study Area (MESA) was known to be representative of statewide disease distribution by several criteria, the goal of this project was to recruit all of the patients in the MESA over the age of 18 years, draw blood samples from these patients for DNA, plasma, and serum collection, and then create a database linking genetic information with phenotypic information extracted from the patient's medical record (see http: /www.mfldclin.edu.prmp/).
The project confirmed through focus groups the sensitivity of patients to the maintenance of privacy for their genetic and health care information and their concerns regarding potential discrimination by employers and insurers based on genetic information. Consequently, a nationally expert Ethics and Security Advisory Board was formed to ensure the security and confidentiality of the database. The database was in a secure area and was free standing, that is, free of connections to the remainder of the Clinic's information system or the Internet. The data were one way encrypted. In addition, the project received a Certificate of Confidentiality from the National Institutes of Health that protected the data against forced release even under court order.
A Scientific Advisory Board was also organized composed of genetic epidemiologists, pharmacogeneticists, and computational geneticists to address the ability of the population to address the pertinent questions, to aid in prioritizing projects, and to help structure the project into a proper multiuser resource.
Patient recruitment began in late September 2002, with 3300 patients enrolled by mid-January 2003, and enrollment continuing at 60-70 patients daily. Funding for the project has come from grants through the Health Resources and Services Administration (HRSA) to address the ethical and scientific issues, through the State of Wisconsin to recruit the patients and collect the biological samples, and through the Marshfield Clinic to further support infrastructure development.
The project is directed toward delineating the predictability of the genetic markers of drug response, outcomes analysis of genetically based prescriptive practices, preventive medicine based on the genetic basis of disease, and answering important questions in population genetics. The hope of this project is that it will allow physicians to use genetic information to be proactive rather than reactive in freeing patients of disease.
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