Medidata Blog
The Digital Solution to Clinical Event Adjudication
Complex clinical trial data management challenges demand quality digital solutions. So it’s no surprise that digital processing is increasingly recognized as the most efficient and reliable way to manage clinical endpoint adjudication by committee (CEC).
In fact, in 2016, a joint industry-regulatory body that oversees pharmaceutical development known as the The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) explicitly recommended the use of eAdjudication platforms in an outline of good industry practices and that such a platform would ideally manage the evaluation, control, communication, review, and risk reporting for endpoint adjudication projects.1
In the 5 years since that report was released, a number of features of digital adjudication platforms have emerged as significant drivers of efficiency and data quality. At the most basic level, a digital adjudication platform’s architecture should be built around cloud-based access and integration with electronic data capture (EDC) systems.
A cloud-based platform allows adjudication committee members around the world to securely and efficiently review clinical event dossiers in real time without the need to download or install software to view documents and images. All they need is Internet access. This reduces the time to complete event reviews and limits the risk of delays.2
Integration of the adjudication platform with a robust EDC solution, meanwhile, reduces errors related to data entry, eliminates the need for reconciliation between sets of documents, and enables process controls and early warnings.3 When data collection, de-identification, dossier aggregation, adjudicator assessments, and CEC management all happen in one place, sponsors and regulators can easily evaluate site performance, run QC on the adjudication process, and compare individual adjudicators to their peer group within and across protocols.4
Flexibility is another building block of the best eAdjudication platforms, which need to accommodate the needs of a wide variety of global trials with different quality control, data collection, and workflow needs. Self-configuration, for example, gives organizations the ability to adjust and optimize timelines, data collection and quality control processes, and the organization of documents and images, as well as the formats in which data is presented to the CEC for each clinical trial.
Flexible workflows also accommodate different sets of data and adjudication processes, which vary from one trial to the next. That’s because each workflow looks different based on the documents that need to be collected and the physicians to whom they need to be routed.
Quality control features should be another top priority for those shopping for digital adjudication platforms. To reduce errors and speed regulatory approval, integrated platforms should provide built-in quality control systems that can facilitate audits of communications between physicians and trial managers, with notes tracking every query and step of the decision-making process.5
Real-time visibility features are also critical. With an up-to-the-minute timeline that maps each clinical endpoint’s journey through the adjudication process, biopharmaceutical and device companies and CROs can prevent delays and missed events, which can generate compliance concerns. The real-time model also allows sponsors to terminate a trial as soon as they have sufficient endpoints adjudicated to analyze their trial for efficacy—potentially saving weeks of time and associated costs.
A few other communication and display features can significantly streamline the adjudication process, as well: automated committee worklists, the ability to generate queries within the system directly to trial sites, proactive reminders and alerts, and integrated display of source documents and images. Together, these attributes can save a trial weeks or—for trials with thousands of endpoints—months.
Ultimately, the best clinical event adjudication platform is also user-friendly and intuitive for all key stakeholders, including sites that are uploading data as well as the event committee members performing the assessments.
As with many other areas of clinical research, innovative new technologies, including Medidata Adjudicate—when combined with scientific and medical expertise—can vastly improve the quality and cost-effectiveness of medicines and medical devices that patients need most.
To learn more about how Medidata Adjudicate helps manage clinical trial adjudication for optimum efficiency and safety, please turn to our white paper on the subject!
Learn more about Medidata Adjudicate.
1 Moe Alsumidaie, “Endpoint Adjudication and the ICHE6,” Applied Clinical Trials, May 24, 2017: https://www.appliedclinicaltrialsonline.com/view/endpoint-adjudication-and-ich-e6 ;“E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry,” U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER), March 2018 procedural.
2 Dan Gebow, “Transforming Clinical Trial Adjudication in the Era of COVID-19,” Applied Clinical Trials, May 6, 2021: https://www.appliedclinicaltrialsonline.com/view/transforming-clinical-event-adjudication-in-the-era-of-covid-19
3 Dan Gebow, “Transforming Clinical Trial Adjudication in the Era of COVID-19,” Applied Clinical Trials, May 6, 2021: https://www.appliedclinicaltrialsonline.com/view/transforming-clinical-event-adjudication-in-the-era-of-covid-19
4 Pardeep Jhund, “Adjudication in Clinical Trials: A primer,” Journal for Clinical Studies, March 4, 2019, Vol.11, Issue 1.
5 Pardeep Jhund, “Adjudication in Clinical Trials: A primer,” Journal for Clinical Studies, March 4, 2019, Vol.11, Issue 1.