Buy or Build: Robust Data Management in Clinical Studies
Considering options like OpenClinica, REDCap, and MIDAS for an effective data management system in Phase 3 clinical studies. Evaluating FDA recommendations, GW BSC needs, and core requirements for the system.
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Buy or Build: Considerations for a robust data management system used in Phase 3 Clinical Studies Society of Clinical Trials Virtual Annual Meeting 2020 Lan Zhang, MS Nisha Grover, MPH Alla Sapozhnikova, PhD Marinella Temprosa, PhD The George Washington University The Biostatistics Center
GW Biostat Center (BSC) Research center founded in 1972. Coordination of NIH funded grants. Over 120 employees. More than 40 biostatisticians/epidemiologists. Experience in biostatistics, epidemiology, study design, data management, and coordination of studies. Expertise in diabetes, maternal fetal medicine, infectious diseases, genetics. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 2
Rationale Compare and evaluate OpenClinica, REDCap, and MIDAS. FDA industry recommendations. GW BSC core needs and requirements. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 3
EDC Concepts Concept Definition EDC System Electronic Data Capture System. Includes computer hardware, software, and associated documents (e.g., user manual) that create, modify, maintain, archive, retrieve, or transmit in digital form information related to the conduct of a clinical trial. Open source A software for which the original source code is made freely available and may be redistributed and modified according to the requirement of the user. Open source has proven to produce better software software that is often more secure, reliable, and flexible than proprietary alternatives. Enterprise Enterprise Application Software refers to a set of integrated software applications and/or systems that are typically purchased from a vendor. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 4
Methodology Evaluation of FDA industry recommendations. Study protocols, SOPs, source documentation, internal security safeguards, external security safeguards, other system features, and training. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 5
MIDAS Developed in 2004 by the BSC. Manages close to 600,000 patient data records. Web based but not open source. Modules customizable by protocol. ePro Participant entry web based module available. FISMA compliant; not 21 CFR Part 11 compliant. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 6
OpenClinica (OC 3) Established since 2006 by Akaza Research. Handles large patient populations. Open-source and web based. Community edition freely available. Enterprise edition incurs licensing fee. ePro Participant entry web based module available. 21 CFR Part 11 compliant. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 7
REDCap Constructed in 2004 by Vanderbilt Univ. Free to institutional partners. Web based but not open source. ePro Mobile application module for data collection without wifi. Studies can configure to meet 21 CFR Part 11 compliance. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 8
FDA Recommended Guidance (1) Study protocols EDC documentation will include how data is collected, modified, transmitted, etc. SOPs Create standard SOPs to detail how data is collected, modified, transmitted, etc. Source Documentation and Retention Source documents must be maintained for the designated period of time. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 9
FDA Recommended Guidance (2) Internal Security Safeguards Limited access, audit trails, date/time stamps. External Security Safeguards Procedures to prevent data or users from entering through unprotected software. Maintain cumulative documentation of authorized personnel. Other system features Direct data entry, retrieving data, dependability system documentation, system controls, change controls. Training Training should be provided to individuals in the specific operations with regard to computerized systems that they are to perform. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 10
BSC Required Features 1. High volume handling 6. CDISC conformity 2. Customization of user roles 7. Randomization module 3. Form design 8. ePro 4. Advanced validation 9. Participant Transfer 5. Real-time reporting 10.Event tracking & adjudication The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 11
Results at a Glance MIDAS OpenClinica Ed. 3 REDCap + Study Protocols (1.00) (1.00) (1.00) + + - - - - + SOPs (1.00) (0.95) (0.95) + - + Source Doc (1.00) (0.75) (0.75) - - Internal Security (0.94) (0.89) (0.92) External Security (1.00) (1.00) (1.00) + + + + Other Features (1.00) (1.00) (1.00) + + + + Training (1.00) (1.00) (1.00) Overall 98% 95% 96% + All recommended guidance in category is available as a functionality -Some of the recommended guidance in category is available as a functionality -None of the recommended guidance in category is available as a functionality The George Washington University The George Washington University The Biostatistics Center The Biostatistics Center 07/31/2020 12
Discussion Meeting regulatory compliance is important. Organizations should consider specific requirements when determining to buy or build an EDC. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 13
Next Steps Compare MIDAS, OpenClinica, and REDCap across the BSC s core needs and requirements. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 14
Acknowledgements The Web The Web Development Development Group Group The GWU The GWU Biostatistics Biostatistics Center Center K. Kim K. Kim The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 15
Thank you! Nisha Grover, MPH ngrover@bsc.gwu.edu http://www.bsc.gwu.edu The George Washington University The Biostatistics Center
References Franklin, Joshua D., Guidry Alicia, and James F. Brinkley. "A Partnership Approach for Electronic Data Capture in Small-Scale Clinical Trials." Journal of Biomedical Informatics 44 (2011): S103-8. Print. GW Biostatistics Center. "MIDAS RA User's Guide." https://dashboard.bsc.gwu.edu/confluence/display/bscmidas doc/MIDAS+RA+User%27s+Guide. Web. 07/29/2020. OpenClinica. "OpenClinica Reference Guide." OpenClinica. Web. 07/29/2020 <https://docs.openclinica.com/3.1/openclinica-user- guide/working-openclinica>. REDCap Vanderbilt University. "REDCap FAQs." REDCap. Web. 07/29/2020 <https://projectredcap.org/about/faq/>. U.S. Department of Health and Human Services Food and Drug Administration (FDA) Office of the Commissioner (OC). Guidance for Industry Computerized Systems used in Clinical Investigations. Authors U.S. Department of Health and Human Services Food and Drug Administration (FDA) Office of the Commissioner (OC), 2007. Print. The George Washington University The Biostatistics Center The Biostatistics Center The George Washington University 07/31/2020 17
