The Clinical Trial Networks Working Group (CTN WG) shares the latest trends and news on clinical trial projects in the area of infectious disease that are going on worldwide.
Managing uncertainty in clinical trials: the role of adaptive trial designs
By Professor Steve Webb – November 2017
Uncertainty about populations, interventions, comparators, effect size, and heterogeneity of treatment effect, applies to all clinical trials, but it particularly affects trials that test the effectiveness of interventions during epidemics. Another major challenge to conducting clinical trials during fast-moving epidemics is the lead-time needed to commence them. In this webinar, Steve Webb discusses adaptive trial design as well as how such trials can deal with uncertainty and be implement-ready (but modifiable) prior to an epidemic.
About the speaker: Professor Steve Webb MBBS, MPH, PhD, FRACP, FCICM, FAAHMS
Dr Steve Webb is a Senior Staff Specialist in Intensive Care Medicine at Royal Perth Hospital and a Professor of Critical Care Research in the School of Public Health and Preventive Medicine at Monash University. He is a trialist who designs and conducts clinical trials that generate evidence to improve patient care.
Dr Webb is a recipient of more than $90M in research funding and has published manuscripts in the NEJM, JAMA, BMJ, and The Lancet. He has an interest in novel trial designs including Bayesian adaptive platform and cluster cross-over designs.
He is a founding Director of the Australian Clinical Trials Alliance, a foundation Fellow and a member of Council of the Australian Academy of Health and Medical Sciences, vice-chair of the International Forum of Acute Care Trialists, a member of the Executive Committee of the International Severe Acute Respiratory and emerging Infection Consortium, a member of the NHMRC Health Translation Advisory Committee, co-chair of the Australian government’s Clinical Trials Collaborative Forum and a Chief Investigator of the Australian Partnership for Preparedness Research on InfectiouS disease Emergencies (APPRISE).
Activities of the GloPID-R WG on data sharing for public health emergencies
By Katherine Littler – September 2017
Katherine Littler, Chair of the GloPID-R Data Sharing Working Group, outlines the WG’s aim and scope, action plan and activities, plus a key piece of work, the Public Health Emergency (PHE) Decision Tool. Data sharing in global health emergencies is critical in order to respond to outbreaks in a coordinated and effective manner. A mandate for change in PHEs was initiated in September 2015 by the WHO consensus meeting, which developed global norms and started to push forward the data sharing agenda. The aim of the Data Sharing WG is to develop a system for data sharing in PHEs which can support the scientific research response, including a common framework, common tools, processes and principles which can be embedded in research practice. This work will be relevant to a broad group of stakeholders, spanning humanitarian responders to vaccine developers.
Reflections on the experience of data sharing between the EU funded Zika research consortia
By Thomas Jaenisch (REDe) – September 2017
Thomas Jänisch acts as a discussant, offering the perspective of a researcher who is responsible for the cross cutting work package on harmonisation and data sharing for the three EU funded Zika consortia. He welcomes standardisation on data sharing and sample sharing and highlights the importance of a transparent approach to identify the critical dataset to be shared in a public health emergency. He also highlights the need for a rational approach of sharing the future work of standardization between the funding agencies and the research community.
The Global Health Network and the resources available for capacity building
By Trudie Lang (REDe) – June 2017
Trudie Lang navigates the Global Health Network (TGHN), which offers “Communities of Practice” for accelerating and streamlining research, and thereby improving health evidence, through a digital platform. This online science park is where research groups can benefit from collaborative working, knowledge sharing and dissemination. It also provides a platform for capacity development and resources. The flagship area for capacity development is the training centre, with 250,000 modules taken, embedded within the Global Health Trials section of the platform. A resource of particular interest for research methodology is the “Process Map” toolkit, which currently provides systematic guidance for planning global health research projects and is being repurposed for use in tracking new studies. The resources available for capacity building include REDe, the research capacity network for preparedness for the EU Zika consortia. This aims to support a rapid and coherent research response to the Zika outbreak in the short term and to establish lasting capacity to conduct research in the event of other vector-borne and emerging infectious disease outbreaks in Latin America and the Caribbean in the long term.
Capacity building activities carried out by ISARIC
By Peter Horby (ISARIC) – June 2017
Peter Horby provides an insight into how capacity building is inherent in everything ISARIC, a global federation of investigator led clinical research networks, does. ISARIC’s mission is to generate and disseminate clinical research evidence; whenever and wherever infectious disease outbreaks occur or are a threat. The pillars of ISARIC’s capacity building activities are clinical research, training and education, and communication and dissemination. Through these activities, ISARIC seeks to accelerate the mobilisation of a clinical research response during epidemics and the generation of evidence that will save lives. In addition to connecting 55 member networks spanning over 100 countries, ISARIC works closely with WHO to host international scientific exchange during major outbreaks and links global partners in health security with the ISARIC clinical research networks.
Mapping ethical, administrative, regulatory and logistical (EARL) barriers and solutions for pandemic-relevant clinical studies in Europe
By Nina Gobat (PREPARE) – June 2017
Nina Gobat describes PREPARE’s work program in which they used social and behavioral sciences to assess ethical, administrative, regulatory and logistic (EARL) barriers to the rapid implementation of pandemic-relevant clinical research in Europe.
The team worked alongside PREPARE clinical studies, currently delivered across community care and hospital networks, to identify where delays arose in inter-pandemic periods and to anticipate challenges and solutions for studies responding in outbreak mode. This was done through a dedicated EARL work package, designed to identify and implement solutions to key EARL bottlenecks. EARL barriers and solutions were mapped to a framework that can be used to develop and enhance research preparedness. This work is on-going and new directions are proposed.
Anthropology and Ebola Research in the 2015 West African Epidemic
By Vinh-Kim Nguyen (REACTing) – June 2017
Vinh-Kim Nguyen gives an overview of REACTing’s approach to anthropological research during the 2015 West African Ebola epidemic, demonstrating how clinical trials in outbreak settings offer unique opportunities for social science research. It also highlights the role of anthropologists in the implementation and uptake of clinical trials.
The focus of social sciences in clinical trials is on understanding the contemporary ways in which sociality is constituted. During the trials, the target communities were studied with as much interest as the trial infrastructure. Vinh-Kim highlights that there is no single “community.” There is a need, therefore, for anthropologists to be aware of the integral part they play and how the way in which they study actually engenders change.
The webinar recordings have been edited with the permission of the presenters and their respective working group network members for the purpose of publication on the GloPID-R website.