e21152 Background: The medical community is continually searching for the best way to treat cancer. The value and utility of biomarkers in guiding treatment decisions is widely accepted but remains a challenge for the bedside clinician and requires ongoing validation and correlation to clinical outcomes. Caris Life Sciences has a dedicated team of scientists who study volumes of scientific literature, synthesize biomarker research and by way of an evidence-based electronic rules engine, translates the application of the literature to biomarker analysis of tumor tissue (The Target Now Report) in support of biomarker-drug association evidence useful in clinical decision-making. Subsequently, Caris initiated the Caris Registry to capture clinical disease, treatment and outcome data from patients who have a Target Now Report. Methods: The Caris Registry is a web-based data entry platform based on an IRB approved protocol. The eligible subject for the Registry will have a qualified Target Now Report. All clinical data elements are defined and supported by the NCI caBIG standardized data dictionary. Disease history/status, treatments and outcomes are captured at enrollment with Day 1 defined as the date of the Target Now Report and every 9 months for 5 years or death whichever is first. Results: As of January 19, 2012, there are 68 participating centers across the country and 43 centers pending IRB submission. There are 852 Target Now cases enrolled with the following cancer lineage distribution: Breast 209, Ovary 169, Lung 117, Colon 79, Endometrium 33, and other 245. There are 323 completed follow up reports and 175 completed end of study reports capturing vital status and cancer related deaths. Conclusions: Caris has successfully launched a scientifically valid and regulatory compliant Registry and database intended to become a robust library of tumor biomarker results linked to clinical outcomes data. As the library grows, data mining could provide vital information access to researchers, pharmaceutical firms, government, academia and insurers for use in drug development, molecular and biomarker research, economic impact assessments, healthcare policy discussion and most importantly directing personalized cancer treatment.
e270 Background: Cancer treatment based on an individual’s tumor profiling has been associated with increased time to progression. Despite this, adoption has been impeded by various technical, financial, legislative, and ethical issues. Implementation of a personalized medicine program into a healthcare system with a goal of improving patient outcomes includes clinician and patient education, increased tumor profiling of patients, data sharing/analysis, expanded research, and billing/reimbursement practices. Methods: A personalized medicine program was implemented at a hospital system. Measures of physician practice included attendance at genomic medicine education sessions, utilization of genetic/genomic tests, enrollment of patients into clinical trials, modifications in billing practices, and submission of data for analysis. Reimbursement of off-label pharmaceutical agents as well as use of aggregate data to inform treatment and enrollment in biomarker-based clinical trials was recorded. Frequency of genetic and/or genomic tests relative to physician and patient education and access to research opportunities was also assessed. Early patient outcomes, overall costs of care, access to clinical trials, and changes in knowledge and communication are also being monitored. Results: Although analysis is ongoing, the initial assessment indicates an increased utilization of genetic and genomic tests, clarity in billing practices, improved reimbursement for off label therapies, and consumption of educational opportunities from clinicians to patients/caregivers. Analysis of the first year implementation will be reported, including evaluation of preliminary results relative to quality of life and survivorship. Conclusions: Preliminary analysis of data from implementation of a personalized medicine program indicates that utilizing relevant education, research, aggressive billing and reimbursement processes, and IT infrastructure, can provide patients with the individual therapies which reduce cost and improve survivorship.
Risks associated with drugs and treatments are a key concern in clinical investigations of therapeutics. There is a keen attention to side effects and adverse events included in critical safety documentation presented in regulatory submissions for new drugs. Likewise, Companion Diagnostic (CDx) technology is subject to rigorous regulated research and testing because of the risk associated with a false test result that could affect clinical decisions and treatment. The rigor of testing imposed by the regulatory path to clearance or approval is intended to ensure an assay is reliable when performance criteria are defined by a fixed set of these variables so that there is the least risk of false test results. The clinical validation of these assays is especially important when the test result is used to manage therapeutic decisions for patients. The same patients that expect a clinician to use reliable diagnostics to recommend treatment may also be recruited to participate in CDx clinical investigations. This educational review of CDx product development, regulations, and clinical investigations involving human subjects is important to: (1) Clinicians who rely on the test results to manage patient care; (2) Patients who trust these test results are informing the clinician, and (3) Hospital administrators who oversee human subjects safety and data intergrity for clinical investigations in the personalized medicine space.
Four studies were conducted to examine the data collection procedures and diagnostic accuracy of Navy Hospital Corpsmen for patients “with acute abdominal pain and to determine the compatibility of their skills with the requirements of a computer-aided diagnostic system for abdominal pain. Findings suggest that instruction in specific data collection procedures results in an increase in the amount of data collected. It does not appear to improve either the accuracy of the data collected or the diagnosis. The instructed corpsmen collected more of the required data for effective use of a computer-based diagnostic system for abdominal pain.
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