Electronic Medical Records Utility in Clinical Trial Conduct
Electronic Medical Records Utility in Clinical Trial Conduct
Patient dropouts and those lost to follow-up (LTFU) pose a major challenge and costly burden in the conduct of clinical trials as each patient represents a valuable source of data. High patient dropout rates are not only costly but pose a risk to the interpretation and validity of intended research findings. Therefore, retention and adherence processes are critical so patients don’t dropout and become lost to follow-up (LTFU).
Such procedures require a combination of patient, physician, and coordinator related factors including recruiting patients per protocol inclusion criteria, managing patient expectations, and efficient recording of all relevant documentation. These are important factors that can favorably influence cost effectiveness. In this regard, electronic medical records ( EMRs ), considered an asset to the health care industry, offer much advantage to clinical research by assisting in recruiting the correct patients to the appropriate clinical trial, 1 aiding in cost effective subject recruitment, and rapidly identifying adverse events.2, 3 These factors can reduce patient dropout rates and patients LTFU. Additionally, EMRs facilitate clinical investigators in maintaining adequate and accurate patient case histories and in providing direct access to source data/documentations for trial-related monitoring required by the FDA,4 GCP guideline and ICH Guideline for Good Clinical Practice (E6).5 Such formation may also provide the necessary information to find a patient LTFU and reintegrate them into the study.
Despite the many advantages of EMRs, there are some potential concerns with their utilization based on data integrity assurance and privacy mandates per the Health Insurance Portability and Private Act (HIPAA) 6,7 for Sponsors of clinical research due to the necessitation of monitors and quality assurance auditors to inspect study records. However, as the HIPAA privacy rule requires that an individual participating in research provide signed permission before records may be accessed by researchers and/or due to FDA-required elements, 8 these concerns can be easily avoided if the informed consent process is conducted as appropriate, which includes an adequately prepared informed consent form (ICF) that is signed by the patient prior to any research related activity. Therefore, if a valid informed consent process is in place, the monitoring of any medical record, including EMRs, even if the EMR is part of a larger record that includes non-research related health information is considered HIPAA complaint.
Importantly, it must be recognized that while Electronic Medical Records (EMR) can greatly enhance the entire clinical trial process and subsequently increase patient retention, reduce dropout rates and patients LTFU, there must be quality monitoring data and recordkeeping systems and standard operating procedures that sponsors have in place to assure data integrity and patient privacy per governing mandates.
1. J.W. Goldwein et al., Abstract No. 6626, Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings, Part 1 Vol. 25, No. 18S (June 20 Supplement) 2007: 6626.
2. M. Mowry and D. Constantinou, “Electronic Health Records: A Magic Pill?” Applied Clinical Trials, February 2007.
3. J.C. Crosson et al, “Electronic Medical Records and Diabetes Quality of Care: Results From a Sample of Family Medicine Practices,” Annals of Family Medicine, 5: 209-215 (2007).
4. Code of Federal Regulations, Title 21, Part 312.62(b) (U.S. Government Printing Office, Washington, DC).
5. Food and Drug Administration, “ICH E6 Good Clinical Practice: Consolidated Guidance, Section 4.9.7, Federal Register 62 (90), 25691-25709 (May 1997).
6. U.S. Department of Health & Human Services, Health Insurance Portability and Privacy Act of 1996 (U.S. Government Printing Office, Washington, DC).
7. Code of Federal Regulations, Title 45, Parts 164-168 (U.S. Government Printing Office, Washington, DC).
8. Code of Federal Regulations, Title 21, Part 50 Section 25(a)(5) (U.S. Government Printing Office, Washington, DC).
Please contact our CEO David Betz at 888-965-6696, and he will answer any immediate questions you have and provide you information about our OmniTrace lost to follow-up patient search services. You can also email David at: dave@omnitrace.com.
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