Nick Medhurst

ALT "Returning to the Principles of Good Randomized Clinical Trials" The six webinar speakers are pictured

ALT Webinar: Returning to the Principles of Good Randomized Clinical Trials Discover how new guidance to promote and enable good RCTs can help make high-quality evidence easier to achieve. Experts from four continents share their insights on how the Good Clinical Trials Collaborative's Guidance can help address global challenges in clinical trials. 6th February 2024, 11:30 -12:30 GMT Register at bit.ly/3tH6lZg Speakers: Dr Rachel Hallett (chair), Capacity Strengthening Manager, GCTC Professor Sir Martin Landray, Senior Lead, GCTC Dr Thomas Nyirenda, Strategic Partnerships and Capacity Development Manager & Head of Africa Office, EDCTP Dr Cristina Torres, Professor of Social Sciences, National Institutes of Health, University of the Philippines Manila Dr Netzahualpilli Delgado Figueroa, Director of Health Research, Secretaria de Salud Jalisco, Mexico

ALT “Collecting high-quality data is vital in clinical trials, but equally important is that the data directly relates to the research question. While the idea of gathering additional data without a clear utilization plan might be tempting, it is important to avoid unnecessary burden and risk on trial participants. We should prioritize quality over quantity, collecting only essential data reliably and efficiently.” Naomi Waithira Head, Data Management Mahidol Oxford Research Unit

ALT In this edition: NIH Pragmatic Trials Collaboratory Grand Rounds webinar: discussing the recent publication of new draft Good Clinical Practice (GCP) E6(R3) guidelines by the International Council of Harmonisation (ICH). To be live streamed this Friday, 18 August, with free access. World Health Organization’s (WHO’s) draft clinical trials guidance outlines key scientific and ethical features of a good clinical trial - now open for public consultation. Good Trials Prism formed to promote best practices in randomized controlled trials (RCTs) in low-resource settings. Upcoming events and what we’ve been reading and listening to.

ALT “Collaboration provides wider access to diverse experience and promotes innovation, elevating the quality of trials. Moreover, involving patients, caregivers and advocacy groups across trial networks ensures their perspectives and needs are represented, enabling researchers to design trials that prioritizes their experiences and ensure results are more relevant for future patient care.”Dr. Mo YinDeputy DirectorADVANCE-ID

ALT What needs to be put in place to create an invigorated CT environment? High quality clinical trials play a crucial role in all areas of medicine by providing useful (reliable, informative, actionable) answers to important clinical questions. Incentivizing and enabling such trials requires active, concerted effort - Prioritize good trial design - Adopt and implement principles-based clinical trial guidance - Establish fit for purpose infrastructure - Maintain and improve through useful practice.

ALT How can ACTEU best support multi-national academic clinical trials? By involving funders, sponsors, regulators, member states, clinical professionals, patients, participants and the public, and creating a platform for holistic, inclusive engagement with key challenges and opportunities (including, for example data infrastructure, ethics and contracting issues). - Common purpose and goals - Shared responsibility - Flexibility and proportionality