Published on January 9, 2009
Research Paper 1 CRA 103 Good Clinical Practices Fall 2006 How Technology Detects Adverse Events & Streamlines Safety Monitoring Research Paper by: Marwah Zagzoug Date: November 16, 2006 George Washington University
Research Paper 2 How Technology Detects Adverse Events & Streamlines Safety Monitoring As part of Good Clinical Practice, the importance of assessing the safety of drug products and reporting adverse events cannot be emphasized enough. Yet despite this well-known fact, the events that occurred with high profile brands such as Vioxx or Baycol are a serious indication that accurate safety reporting is one of the most difficult tasks for a study to do (Gudat, 2006). Often times, there are too many misunderstandings about what is necessary for reporting on safety issues in trials. One of the reasons leading to this problem falls back on the regulations (Ginsberg, 2005). Although the regulations are clear on holding the investigator responsible for protecting the rights, safety and well-being of subjects in trials, they do not provide any information about the details of what is needed in actual safety reporting. Nevertheless, the integration of technology has proved to be a novel approach in ensuring accurate reporting of adverse events, making certain that all elements of proper safety monitoring are addressed. Regulations & Definitions: According to the regulations, 21 CFR 312.64 states, “an investigator shall promptly report to the sponsor any adverse effect that may be reasonably regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming the investigator shall report the adverse effect immediately.” (FDA Investigational New Drug Application, 2006). An adverse event, as defined by the International Conference on Harmonization, or the ICH, is “any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and
Research Paper 3 unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product” (ICH, 1996). An adverse drug reaction, or ADR, is another term that applies to any untoward response in a subject to an investigational product which is related to any dose administered to that subject. Conversely, a serious adverse event, or a SAE, is a medical occurrence that is unexpected and may be life threatening or may result in hospitalization, disability, birth defect, or death. Introducing Information Technology in Reporting Adverse Events: Not all adverse events are considered serious. Some can be purely coincidental or related to the underlying illness, but regardless they are all recorded and reviewed accordingly. Proper recording and reporting of adverse events is the basis of clinical risk assessment. That is why over the years, the industry has focused its efforts on enhancing trial safety systems. To avoid incidents similar to that of Vioxx, the industry is embracing today’s technology to make significant improvements in monitoring drug safety before new treatments reach the market. These advancements are possible with the use of web-based electronic data capture, otherwise known as EDC (Rogers, 2006). When computerized detection was initially introduced, data was used to identify a signal that suggests the possible presence of an adverse event. This would then initiate an investigation and alert the user to intervene. A study conducted by Bates et al. (2003) and published in The Journal of the American Medical Informatics Association concluded that computerized tools hold great promise in detecting and reporting larger numbers of adverse events. In fact, a growing number of studies indicate that
Research Paper 4 spontaneous reporting of adverse events is clearly insufficient and that computerized techniques should be further explored (Bates et al., 2003). Using Today’s Technology for Safety Monitoring: In recent years, devices such as cell phones, desktop PCs, PDAs and pagers have been incorporated as tools for safety monitoring and reporting adverse events (Rogers, 2006). With these tools, sponsors can receive immediate notification of potential adverse trends during ongoing studies in real-time. Thus, sponsors no longer have to wait weeks or months to review data derived from clinical studies conducted at multiple sites. This type of technology offers several advantages. For starters, it provides more aggressive approaches to safety monitoring. For instance, patient safety can be assessed on an ongoing basis rather than being restricted to annual or biannual Data Safety Monitoring Board meetings. It can also send safety alert triggers to minimize subject risk and terminate a subject from a trial when the data indicates potential safety concerns. In addition, safety data between treatment groups can be analyzed by the EDC system without breaking a blind study. These are just a few of the benefits that electronic safety notification can offer (Rogers, 2006). One of the most recent software solutions in adverse events reporting was announced this past month when Phase Forward Inc., a leading data management provider, released Clintrace 4.1. This new software features FDA regulatory compliance and enhanced AE reporting capabilities as well as enhanced data analysis capabilities (BIOWIRE, 2006). Thus it enables users to build reports for timely notification, improve decision making for assessing the relationship of an AE to the study drug, and facilitate faster resolution of adverse events.
Research Paper 5 The Next Direction in Safety Monitoring: It is without a doubt that electronic and computerized detection and reporting of adverse events will continue to expand with widespread use. It is likely that data management companies are exploring ways to modify current technology to adapt in ways that permit better detection of adverse events on a larger scale. As clinical information becomes computerized and stored electronically, a new generation of tools empowered with larger databases will build on previous tools like Clintrace and its predecessors for the pursuit of increased safety monitoring in clinical trials.
Research Paper 6 References Bates, D. W., Evans, S., Murff, H., Stetson, P. D., Pizziferri, L., & Hripcsak, G. (2003). Detecting Adverse Events Using Information Technology. The Journal of the American Medical Informatics Association, 10(2), 115–128. Retrieved on November 17, 2006, from http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=150365 BIOWIRE. (2006, September 5). Phase Forward Enhances Clinical Adverse Event Reporting and Regulatory Compliance; Clintrace 4.1 Features Reporting Capabilities Achieved Through Integration with Cognos ReportNet, Compliance with FDA MedWatch 3500A Guidelines. Genetic Engineering News. Retrieved November 17, 2006, from http://www.genengnews.com/news/bnitem.aspx?name=5093817&taxid=20 FDA Investigational New Drug Application 21 C.F.R. § 312.64 (2006, April 1). Retrieved November 16, 2006, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.64 Ginsberg, D. (2005). Adverse Events and Safety Monitoring. In, Becoming a Successful Clinical Research Investigator, (pp 137-149). Boston, MA: CenterWatch. Gudat, U. (2006, October 1). Assessing Safety in Clinical Trials. Applied Clinical Trials. Retrieved November 17, 2006, from http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=377750 ICH Harmonized Tripartite Guideline. (1996, June 10). Guideline for Good Clinical Practice. Retrieved November 16, 2006, from http://www.ich.org/LOB/media/MEDIA482.pdf Rogers, J. (2006, February 1). Electronic Alerts Advance Safety. Applied Clinical Trials. Retrieved November 17, 2006, from http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=306514
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