Infectious diseases are an important global concern, but traditional randomised controlled trials lag behind what is needed in terms of rapid development of diagnostics, vaccines, and treatments. In particular, fixed trial designs cannot adapt to rapidly evolving research findings and treatments, hindering their utility in the context of an emerging pathogen.
In contrast, adaptive trial designs offer a compelling alternative where trial parameters can be modified during the trial, based on pre-specified rules, to respond to emerging research findings. The European Clinical Research Alliance on Infectious Diseases (Ecraid) has embraced adaptive trial designs as a tool for facilitating faster, more efficient, and higher-quality clinical research. The foundation, which coordinates Europe's largest 'warm-base' clinical research network for infectious diseases, is involved in various trials adopting some form of adaptive design. Such as the ground-breaking trials REMAP-CAP and RECOVERY, both of which have achieved unmatched speed and efficiency thanks to their adaptive platform design.
Adaptive clinical trial designs' is a very broad area of research, which encompasses many different designs, and each design can be implemented using several different techniques. These training modules will introduce the different types of adaptive designs and explain their advantages and limitations. Experts in the field will also describe the challenges of implementing these trials in practice. This series offers a unique opportunity to learn from world-leading experts about all the different aspects of adaptive clinical trial designs in the domain of infectious diseases, featuring amongst others Lennie Derde, Thomas Jaki, and Marc Bonten. It will be a free modular series, which you can follow at your own convenience. Everyone interested in the future of clinical development in infectious diseases should follow these training modules.
Marc Bonten (Utrecht, Netherlands), Scott Berry (Austin, USA), Lennie Derde (Utrecht, Netherlands), Thomas Jaki (Regensburg, Germany), Sarah Walker (London, UK), Jean-Francois Timsit (Paris, France), Julia Bielicki (London, UK), Chris Jennison (Bath, UK), Antoni Torres (Barcelona, Spain), Sofia Villar (Cambridge, UK), Lorenzo Guglielmetti (Paris, France), Carole Mitnick (Boston, USA), Pavel Mozgunov (Cambridge, UK), Rieke van der Graaf (Utrecht, Netherlands), Valentijn Schweitzer (Utrecht, Netherlands), Thomas Burnett (Bath, UK), Mo Yin (Singapore), Matteo Cellamare (Washington, USA), Eveline Verheijen (Utrecht, Netherlands), Bern-Thomas Nyang'wa (London, UK), Marlieke de Kraker (Geneva, Switzerland), Holly Jackson (Geneva, Switzerland).
Each module will include lectures about the theory of each adaptive trial design and an example of their use in practice. Opportunities to dig deeper and test your knowledge through Q&A and asynchronous interaction with experts and fellow participants through an online forum.
Module 1: General introduction to Ecraid and adaptive trial designs - available 31.01.2024
Module 2: Seamless trial designs & endpoint selection - available 29.03.2024
Module 3: Group sequential designs and sample size re-estimation - available on 31.05.2024
Module 4: Response adaptive randomisation and covariate-adjusted response adaptive randomisation designs - available 31.07.2024
Module 5: Platform trials and the personalised randomised controlled trial - available on 30.09.2024
Module 6: Ethical and logistical concerns for adaptive designs, and CME test - available on 29.11.2024
ERS is one of 19 partners in the European Clinical Research Alliance on Infectious Diseases (Ecraid) consortium. Ecraid has launched a new educational series, the Ecraid training modules on adaptive clinical trial designs.
Those with an interest, or experience, in clinical research or clinical trials with basic statistical knowledge, including hypothesis testing and methods for traditional randomised controlled trials.
After following these training modules, participants should be able to:
An online CME exam will be made available at the end of the series. Participants will be granted a CME certificate upon successful completion of the exam.
The adaptive platform trials toolbox aims to compile the accumulated knowledge, experience and resources from multiple projects and trials into a practical and guided toolbox to facilitate the planning and conduct of future Adaptive Platform Trials in any therapeutic area.
Developed by ECRIN (European Clinical Research Infrastructure Network) through the RECOVER and EU-Response shared work package, the Adaptive Platform Trials Toolbox currently contains over 130 resources. Browse the resources by category and keyword and delve into the contents. Each tool is presented with a brief explanation indicating the tool's format and a direct access link. For more information, visit
https://covid19trials.eu/en/adaptive-platform-trial-toolbox
The European Clinical Research Alliance for Infectious Diseases (Ecraid) is a non-profit organisation that advances clinical research in the field of infectious diseases through international collaboration. Headquartered in Utrecht, the Netherlands, Ecraid offers a single point of access to key academic opinion leaders and Europe's largest academic clinical research network for infectious diseases. For more information, visit www.ecraid.eu.
The ECRAID-Base project is funded by Horizon 2020 through the Grant Agreement n° 965313.