Clinical trial eligibility determination using an oncology electronic medical record system interfaced to a caBIG-certified trial database

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6626-6626
Author(s):  
J. W. Goldwein ◽  
M. Van Der Pas ◽  
L. Tis ◽  
R. Nickens ◽  
R. Comis
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Record ◽  
Electronic Medical Record ◽  
Performance Status ◽  
Stage Iv ◽  
Clinical Trial Registration ◽  
Record System ◽  
Eligibility Determination ◽  
Stage Iv Breast Cancer

6626 Background: One reason for the low numbers of patients entered on cancer clinical trials is the difficulty and inconvenience encountered in determining whether patients are eligible. The introduction of electronic medical record (EMR) systems in cancer facilities provides a means by which clinical parameters may be electronically collected and compared against clinical trial eligibility criteria, with the potential to facilitate eligibility determination. We hereby describe a widely utilized EMR system interfaced to a caBIG-certified searchable clinical trials database which facilitates eligibility determination. Materials and Methods: MOSAIQ is a widely utilized oncology- specific EMR system that is operational in radiation and medical oncology facilities world-wide. During the routine course of patient care, clinical trial eligibility parameters such as diagnosis, stage, age, and performance status are entered into defined data fields within the EMR. Trialcheck is an independently maintained caBIG bronze level certified database that lists thousands of clinical trials from Cooperative Groups, NCI/PDQ, the pharmaceutical industry and trials being conducted exclusively at particular oncology facilities. TrialCheck registrants can screen trials for patient eligibility as well as filter and track the status of trials that have been activated at their facility. In addition, a real-time, secure Internet interface between MOSAIQ and TrialCheck extracts eligibility parameters from a patient record, sends that information to TrialCheck, and returns a listing of matched clinical trials. Results: In a test screen of 4 MOSAIQ EMR patients against 257 TrialCheck clinical trials, the system matched a patient with Stage IV breast cancer to 7 available trials in less 2 seconds, a patient with Stage IIIB colon cancer to 3 trials in 5 seconds, a Stage IV prostate cancer to 5 trials in 4.4 seconds, and a patient with stage II esophageal cancer to 2 trials in 3.7 seconds. Conclusion: This product demonstrates a novel and innovative solution to one of the problems inherent in the clinical trial registration process in an efficient, reliable and secure manner. No significant financial relationships to disclose.

scholarly journals Enhancing Diversity in Oncology Clinical Trials: Findings of a Case Study in Improving Black Patient Representation in a Multiple Myeloma Trial

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3008-3008
Author(s):  
Sudip Bhandari ◽  
Charles Lagor ◽  
Judith Mueller ◽  
Warren Whyte ◽  
Samuel Heilbroner
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Clinical Trials ◽  
Medical Record ◽  
Electronic Medical Record ◽  
Health Disparity ◽  
Black Patient ◽  
The United States ◽  
Black Patients ◽  
Car T

Abstract Background: Black patients are underrepresented in multiple myeloma (MM) clinical trials. Despite the promise of Real-World Data (RWD), little research exists on RWD's usage to address this health disparity. In collaboration with a large pharmaceutical partner, we used RWD from commercial datasets (ConcertAI's Electronic Medical Record and claims datasets) aimed at identifying sites with a large Black patient population. We recommended including these sites in a recent clinical trial of Chimeric Antigen Receptor T cell (CAR-T) therapy for MM patients. Methods: We used the following criteria to identify promising sites: (1) high Black patient density, (2) access to a CAR-T accredited parent organization within 100 miles, (3) a hematologist/oncologist who treats MM patients, and (4) a history of treating MM patients with a Proteasome Inhibitor (PI) and Lenalidomide (Len) in the first line of therapy. For (1), sites were ranked using the lower 95% confidence interval for the percent of Black MM patients at the site. For (4), only sites with at least five MM patients who received PI and Len were included. Our data sources were: ConcertAI's Electronic Medical Record (EMR) and claims datasets to link each patient to a site, and Google maps API to identify the CAR-T center nearest each oncology site. The patients in our data sets were not identifiable, and our research was conducted in compliance with the Health Insurance Portability and Accountability Act. After having identified and filtered promising sites, we curated individual candidates in the order of Black patient density. The purpose of curation was to validate a final list of sites. Results: We identified 17 promising clinical trial sites affiliated with 16 healthcare systems in the mid-west, mid-Atlantic, southeastern, and southwestern regions of the United States (table 1). Our RWD captured an average of 141 MM patients (range: 6-791) who were treated at the 17 sites from 2015-2020. Thirty-nine percent of the patients were Black (range: 13-67%). This percentage was three times the recruitment rate of black patients in MM trials in the US (13%). On average, the sites were 44 miles driving distance (range: 0.8-96 miles) from the closest CAR-T center, had eight hematology/medical oncology specialists on staff (range: 1-17), and had previous interventional trial experience (13 sites had experience with MM trials). All of the identified sites were community-based sites, and none of the sites were previously identified by our pharmaceutical partner. Conclusions: We demonstrated that RWD can be leveraged to identify clinical trial sites with a high potential for Black patient recruitment, thereby addressing a known health disparity problem within multiple myeloma (MM) clinical trials. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

scholarly journals Forecast of Outpatient Visits to a Tertiary Eyecare Network in India Using the EyeSmart Electronic Medical Record System

Healthcare ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 749
Author(s):  
Gumpili Sai Prashanthi ◽  
Nareen Molugu ◽  
Priyanka Kammari ◽  
Ranganath Vadapalli ◽  
Anthony Vipin Das
Keyword(s):  
Medical Record ◽  
Electronic Medical Record ◽  
Time Series Data ◽  
Resource Planning ◽  
Healthcare Services ◽  
Electronic Medical Record System ◽  
Series Data ◽  
Record System ◽  
Outpatient Visits ◽  
Medical Record System

India is home to 1.3 billion people. The geography and the magnitude of the population present unique challenges in the delivery of healthcare services. The implementation of electronic health records and tools for conducting predictive modeling enables opportunities to explore time series data like patient inflow to the hospital. This study aims to analyze expected outpatient visits to the tertiary eyecare network in India using datasets from a domestically developed electronic medical record system (eyeSmart™) implemented across a large multitier ophthalmology network in India. Demographic information of 3,384,157 patient visits was obtained from eyeSmart EMR from August 2010 to December 2017 across the L.V. Prasad Eye Institute network. Age, gender, date of visit and time status of the patients were selected for analysis. The datapoints for each parameter from the patient visits were modeled using the seasonal autoregressive integrated moving average (SARIMA) modeling. SARIMA (0,0,1)(0,1,7)7 provided the best fit for predicting total outpatient visits. This study describes the prediction method of forecasting outpatient visits to a large eyecare network in India. The results of our model hold the potential to be used to support the decisions of resource planning in the delivery of eyecare services to patients.

scholarly journals Practical and conceptual issues of clinical trial registration for Brazilian researchers

2015 ◽  
Vol 134 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Carolina Gomes Freitas ◽  
Thomas Fernando Coelho Pesavento ◽  
Maurício Reis Pedrosa ◽  
Rachel Riera ◽  
Maria Regina Torloni
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
International Committee ◽  
New Drugs ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Registration Process ◽  
Trial History ◽  
Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

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