![]() ![]() The Clinical Trials of Today and Tomorrow Require an EDC Solution That Accommodates a Multitude of Potential Mid-Study Modifications ![]() Inflexible solutions supported by inexperienced teams will disrupt sites, patients, and study teams, creating obstacles to efficient data collection and major logistical headaches. These results emphasize the need for robust, flexible, and scalable EDC solutions to accommodate increasingly frequent and complex mid-study changes to enable continuous, uninterrupted trial progress. Further, mid-study changes delayed trials for a minimum of one month. In Phase III, protocols for rare diseases usually involve an average of 3.8 substantial amendments, 19% more than non-rare diseases.Īdditionally, the CSDD found that 56.5% of respondents to a global survey noted that planned updates to EDC systems or protocols are their biggest data management challenge, while 48.4% cited unplanned updates as their most significant challenge. For rare diseases, Phase II protocols typically require an average of 4.3 substantial amendments, almost 65% higher than the average for non-rare diseases. Protocol amendments are particularly common in oncology, with Phase II protocols having nearly twice the average number of substantial amendments compared to non-oncology protocols. The Tufts report defines substantial amendments as any major change to a protocol on a global level requiring suspending patient enrollment obtaining internal approval followed by approval from an ethical review board or regulatory authority and then re-consenting study participants.Īmendment frequency has also increased in recent years-particularly in trials with more complex designs, such as oncology. Between 20, over 59% of all clinical trials executed at least one substantial amendment, with even more in Phase II and III studies (78% and 69%, respectively). In a recent publication by the Tufts Center for the Study of Drug Development (CSDD), protocol amendments were shown to be increasingly prevalent in clinical trials. Electronic Data Capture Solutions Must Be Flexible to Handle the Increasing Frequency of Mid-Study Protocol Amendments The combination of our technology and experienced Professional Services team ensures smooth implementation of mid-study changes, allowing for fully compliant trial continuity and uninterrupted progress for even the most complex, large-scale, and time-critical trials.ĭiscover the importance of using a robust, scalable, and flexible EDC solution that handles mid-study changes for even the most complex clinical trials. Medidata and our customers perform an average of over 30,000 mid-study changes per year (2019-2022) and a total of 300,000+ since 2005, including for studies with tens of thousands of patients. It requires no downtime when executing mid-study changes that are preplanned (adaptive trial design) or unplanned (protocol amendments). Medidata's Rave EDC (electronic data capture) system is designed to meet the flexibility challenges of clinical trials. Proactive risk mitigation for research data quality issues to help prevent trial delays.Įmpowering a risk-based approach to source data verification by focusing on critical data.Ī cloud-based remote site access and monitoring solution. ![]() Quickly and accurately develop investigator grant budgets.Ī dynamic digital solution for risk assessment, monitoring, and mitigation.Ī powerful data & risk surveillance tool to improve data integrity & reduce trial risk. Unify your clinical research study data and financial management in one platform. Manage electronic trial master file content while maintaining readiness & compliance. Improve speed and efficiency for the oversight of studies with Rave CTMS (Clinical Trial Management System). Seamlessly generate, distribute, & manage clinical study files at the end of a study.ĭrive faster timelines across the trial lifecycle with centralized data & analytics.Ī streamlined, single digital endpoint adjudication system.
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