For the first time, 36 world-leading institutions among European university hospitals, research centers, patient groups, non-profit product developers and pharmaceutical companies are coming together for the first time, to shape the adaptive clinical trial platform of the future.
The project, called EU Patient-cEntric clinicAl tRial pLatforms (EU-PEARL), is a unique public-private strategic partnership funded by the Innovative Medicines Initiative (IMI) to conceptualise and lead the design of an integrated research platform, enabling patient-centric drug development in Europe.
As one of the 36 partners, researchers at NDORMS will contribute to the creation of patient data networks, and to the use of common data models for clinical trial data.
Participants in EU-PEARL have the ambition of transforming the current approach of conducting single-compound clinical trials into the use of cross-company Integrated Research Platforms (IRPs), specifically for early development and focused on patients' interests, while seeking opportunities to address medical needs through the advancement of novel molecules.
The intent is to shape future clinical trials that will be more patient friendly by design and patient focused by outcome in four diseases areas: Major Depressive Disorder, Tuberculosis, Non-Alcoholic Steatohepatitis and Neurofibromatosis; and provide the framework for designing and executing IRPs in other disease areas.
The current model of evaluating one drug at a time in one trial often results in a long, sequential cycle of drug development, substantial investment and delays in getting the most effective treatments to patients. Competing trials challenge patient recruitment and patients often struggle to navigate the complex trial landscape to find the optimum clinical study.
A platform trial is a clinical trial with a single master protocol in which multiple treatments are evaluated simultaneously. Adaptive platform designs offer flexible features such as removing a treatment group for futility or adding new groups and treatments to be tested during the course of the trial.
Dani Prieto-Alhambra, Professor of Pharmaco- and Device Epidemiology at NDORMS, University of Oxford said: “EU PEARL will be a game changer that will facilitate the conducting of platform trials in Europe, and the speedy and reproducible analysis of the resulting data”.
The five pillars of EU-PEARL
EU-PEARL is based on these pillars:
The hospital hubs: The clinical network of hospitals will provide experienced environment for clinical trials and an ideal space to foster interaction of all stakeholders.
The patients: EU-PEARL will foster an environment for patient engagement to play an important role in approaches to change the way clinical trials are conducted.
Methods and Tools: EU-PEARL will develop an integrated set of methods and tools for the planning, implementation and analysis of adaptive platform trials.
Regulatory framework: To provide the necessary standards to ensure that the collection and inclusion, processing and use of health and wellbeing data complies with European and national data protection and ethical regulations, regulatory requirements and legislation.
Data governance: This project will also create the associated data governance ecosystem focusing on interoperability and quality of investigator/patient data; robust policies for access to global data and the creation of a governance structure for transparency, engagement and utilisation.
