Informatics Needs and Challenges in Cancer Research Workshop Summary (2012) / Chapter Skim
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4 Informatics-Supported Cancer Research Endeavors
4 Informatics-Supported Cancer Research Endeavors
Pages 43-62
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From page 43... ...
out comes database is one example of a collaborative data collec tion system that is relevant to both clinical practice and robust clinical outcomes research. · Web-based EHR systems can facilitate real-time alerts, deci sion support capability, and multiple user applications.
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From page 44... ...
CASE EXAMPLE: DELL-TGen CLOUD COMPUTING COLLABORATION IN PERSONALIZED MEDICINE FOR PEDIATRIC NEUROBLASTOMA Spyro Mousses, vice president in the Office of Innovation and director of the Center for BioIntelligence at the Translational Genomics Research Institute (TGen) , described a clinical trial using molecularly guided individualized therapy in pediatric cancer as a case example of successful alignment of biomedical science and informatics.
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INFORMATICS-SUPPORTED CANCER RESEARCH ENDEAVORS 45 Evidence-based Information-enabled Intelligence-based medicine medicine medicine Target population Therapeutic option 1 A A Selection of representative Therapeutic option 1 study cohort Drug of choice for 30% Response rate EVERYONE in target population Therapeutic option 2 Option 2 is not approved for this Clinical trial 20% Response rate indication B Target population Figure 4-1 A (top panel) .eps Therapeutic option 1 Therapeutic option 2 A B Good-outcome Poor-outcome Selection of representative patients patients study cohort Association of molecular feature to phenotype/response C Figure 4-1 B (middle panel)
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From page 46... ...
About a decade ago, TGen started to take the fundamental steps in the direction of molecular-based cancer treatments and has been using technologies ranging from simple gene expression and chemical assays to whole-genome sequencing to identify targets, Mousses said. Molecularly Guided Individualized Cancer Therapy As an example of the N of 1 approach to drug development, Mousses described an ongoing pediatric neuroblastoma clinical trial.
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From page 47... ...
Opportunities in the Cloud The TGen model for personalized medicine clinical trials facilitates intelligent use of the data to help each individual patient, Mousses said, but it does not yet allow for repurposing the data for secondary studies. TGen's future vision is to provide a system that effectively links the pediatric oncology community, including software, hardware, and protocols that support data exchanges so that they are secure.
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From page 48... ...
The overarching mission of the network, explained Kimary Kulig, vice president of clinical and translational outcomes research at NCCN, is to improve the quality, effectiveness, and efficiency of oncology practice so that patients can live better lives. NCCN seeks to enhance care through information resources, outcomes research, and clinical trials, and to develop information resources that are valuable to patients and other stakeholders within the health care delivery system.
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From page 49... ...
With the architecture in place, databases for other tumor types were subsequently launched, including non-Hodgkin's lymphoma, colorectal cancer, non-small-cell lung cancer, and ovarian cancer. Structure and Operations The NCCN outcomes database is governed by the Scientific Office, a virtual office that includes investigators who are chairs of each of the tumor-specific databases.
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Five NCCN sites are currently using electronic data transfer for the breast cancer database, Kulig said. This is particularly important at highvolume sites to maximize efficiencies (e.g., eliminates the need to enter the same data multiple times into various databases, such as the tumor registry, the NCCN database, or any internal databases)
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In conclusion, Kulig said, the NCCN outcomes database is one example of a collaborative data collection system that is relevant to both clinical practice and robust clinical outcomes research. Observational, real-world data hold value for key stakeholders.
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McKesson Specialty Health partners with community cancer care practices to help them manage increased competition from hospitals and clinics, declines in reimbursement, health care reform uncertainty, and rising health care costs. McKesson Specialty Health is the second-largest business unit of McKesson, which is one of the l argest distributors of specialty pharmaceuticals and biologics.
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For example, data in the common core framework could be used for real-time clinical alerts that could inform the clinician about a newly diagnosed patient for the purposes of clinical trial recruitment or alert the nurse to a scheduled appointment for a patient coming for the first dose of treatment. The same technology drives alerts for pharmaceutical manufacturers that may include aggregate, de-identified data regarding use of their products.
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The same data are integrated with the clinical trial management system, Ahmad said; this has facilitated the enrollment of more than 50,000 patients in various clinical trials over the past 8 years. Data Governance Because no defined standards are fully implemented with regard to EHRs, the data remain somewhat "dirty," Ahmad said.
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From page 55... ...
Patient-centered outcomes research is a relatively new term, Wallace explained, and there has been some tension as to what it is and what it is not, as well as how it contrasts with personalized medicine. According to the PCORI working definition, patient-centered outcomes research helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options.
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. The key difference between evidence-based medicine and CER, Wallace suggested, is that CER attempts to include those groups of people who were ineligible for and excluded from clinical trials, using observational data to complement and extend what was learned from the trial.
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A different approach is to plan for secondary use. This may involve structured data capture, expanded common datasets outside clinical trials, or common intervention protocols.
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Panelists included Gwen Darien, director of the Pathways Project and cancer survivor, Deven McGraw, director of the Health Privacy Project at the Center for Democracy and Technology, James Cimino, chief of the NIH Laboratory for Informatics Development, and Steven Piantadosi, director of the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center. Engaging Patients Gwen Darien offered the patient's perspective based on both her personal experience as a cancer survivor and input from her colleagues in the advocacy community.
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Building trust in research requires research institutions to be mindful of the sensitivity of the data, to treat them with respect, and to make good decisions about how the data are to be used. McGraw suggested that one of the ways to rely less on consent and build trust is to improve transparency, both to the public at large and to cancer patients, about how patient data are used, the typical tools that institutions use to protect data, and oversight and accountability for those protections.
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He urged caution when making inferences based on data that were not collected for that purpose. One example is when a safety signal emerges in a clinical trial designed to consider a therapeutic question.
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2012. Patient-centered outcomes research.
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