Basel, Switzerland-based Ethical, a provider of Centralized Endpoint Adjudication solutions for clinical trials, and the Cambridge, Mass.-based Alliance for Clinical Research Excellence and Safety (ACRES), a multi-sector nonprofit organization building a multi-stakeholder-driven integrated global system for clinical research, have partnered to improve Centralized Endpoint Adjudication—an essential element of drug development.
The new collaboration, which brings Ethical into the alliance, a rapidly growing collaborative of innovation-focused organizations spanning the global clinical research enterprise, focuses on improving data quality and processes in clinical research by leading standardization efforts in Endpoint Adjudication in clinical trials.
Endpoint adjudication plays a key role in the approval of new therapies by regulatory authorities. The current process, however, is plagued by a lack of standards when dealing with existing subjective endpoints and the inconsistent use of independent review committees across disease states. Also, the conventional paper-based nature of endpoint adjudication adds to problems with time-consuming, inefficient and error-prone processes due to loss of adjudication dossiers or deficiencies in the endpoint adjudication decisions.
The collaboration initially will explore opportunities for streamlining and improving the Endpoint Adjudication process effectiveness. Ethical’s Endpoint Adjudication solutions bring the Ethical eAdjudication Platform to ACRES shared global platform of integrated technologies to improve the integrity of data and reduce trial costs. Ethical and ACRES also will explore development of shared standards across service providers, stakeholders managing Endpoint Adjudication Committees and sponsors. Ethical will participate in ACRES’ Foundation Initiatives related to quality management, contributing to the “dynamic accreditation” process being developed by the alliance.