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Inform edc dcri duke11/24/2023 ![]() The movement toward technology-enabled clinical research in which software products are integral to the research process does introduce new challenges. Upon proper validation, these web-based platforms-where patients can be consented, interact with investigators through telemedicine devices, record ePROs, and automatically upload vital signs through applications on the participants’ own smartphones-not only have the potential to reduce the time burden imposed on the participants and study teams by obviating the requirement for traditional in-clinic study visits, but also permit continuous real-time data collection more representative of the daily living environment of participants, and empower them to be more engaged in research.Īre there any processes currently conducted on software programs that you have found problematic, wanting, or all-over challenging? Shifting the paradigm from site-centric to patient-centric clinical trials is best exemplified by the conduct of the so-called virtual trials (also called decentralized trials) made possible by a set of mobile technologies to continuously capture ePROs and digital biomarkers such as step count, heart rate, and blood pressure. If you had one technology to use on a clinical trial, what would it be and why? Inaccurate data attribution, mobile device failure, programmed obsolescence, and silos of representativeness excluding participants with poor technological literacy all constitute challenges specific to the conduct of technology-enabled trials that have to be taken into consideration early in the planning stage to ensure quality and efficiency in the conduct of trials. Digitization of the protocols has the potential to generate efficiencies and support complex operationalization of protocols at the site level, at the cost of extensive training for the personnel in charge of digitization. For example, before replacing traditional central blinded endpoint adjudication by EHR-derived data, completeness, accuracy, and precision of the data requires validation efforts to be conducted, and regular curation of the databases is necessary. However, no compromise on the quality of data can be made, as evidentiary standards for regulatory and scientific purposes needs to be maintained. EHR-based, electronic patient-reported outcomes (ePROs) from mobile health applications and digital biomarkers derived from biosensors allow researchers to streamline safety monitoring and endpoint ascertainment processes by eliminating requirements for in-clinic follow-up with traditional paper-based case-report forms. Capitalizing on the efficiencies enabled by technologies to facilitate the conduct of clinical trials requires the expansion of the study team to include information technologies specialists, health systems specialists, and data scientists.Īlso, experts in advanced analytics are the linchpin required to enable the integration of massive volumes of data accrued through emerging technologies. Inasmuch as technologies can provide economies of scale at every stage of the trial process, from design to analysis, poor implementation can lead to wasted resources. When so many processes are still conducted on paper, can the right technology make or break a clinical trial? The ongoing efforts to provide a platform and ecosystem for clinical research is a long overdue and an advance which we welcome enthusiastically. With this rapid rise of viable solutions, the challenge has changed from an era of too few solutions to navigating a complex landscape of point solutions. While the DCRI continues to utilize many solutions designed for our specific purposes, the trend toward cloud-based solutions is clearly underway. ![]() With the explosive growth of cloud technologies, the vendor landscape has grown dramatically. Historically, many of the tools needed for research have been provided through in-house software development efforts of niche vendors largely architecting their solutions through on-premise infrastructure.
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