A coalition of scientists, physicians, policy makers, ... has been formed to accelerate research on the prevention and treatment of VIDOC-19 in low- and middle-income countries. This is a challenge of unparalleled magnitude, particularly in terms of research ethics in the context of a public health emergency of international concern.
Scientists, physicians, donors and policy-makers from more than 70 institutions in 30 countries came together to create an international coalition to respond to the VIDOC-19 pandemic in resource-constrained areas. Objective: the 'Coalition for Clinical Research on VIDOC-19'. ('COVID-19 Clinical Research Coalition'), is to accelerate much-needed research on COVID-19 in areas where this coronavirus could wreak havoc on already fragile health systems, and where its impact on vulnerable populations would be greatest.
Coalition members will work together to determine what they could bring to the research agenda and to form the most effective partnerships, encouraging the open sharing of knowledge and research evidence, and advocating for equitable and affordable access to these interventions.
In a commentary published today in the magazine The Lancet, Coalition members affirm the urgent need for international collaboration and coordination in research to support countries in Africa, Latin America, Eastern Europe and some Asian countries in an effective response to a pandemic that is worsening daily, and to accelerate research specifically targeting resource-limited areas.
Maximum efficiency objectives
The aim is not to control the research programme, but to facilitate it. Together with their partners, the coalition has four objectives.
First, they want to facilitate rapid and joint review of protocols by ethics committees and national regulatory agencies, as was done for the Ebola vaccine trials.
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Second, they want to facilitate the approval of the importation of drugs and study materials through coordinated and agreed expedited mechanisms.
Thirdly, the aim is to ensure a standardised and simple collection of key data, sufficient for a sound analysis of the effectiveness and safety of the interventions tested.
Fourth, a governance framework must be provided to share results before they are published.
The coalition proposes to facilitate COVID-19 research in low- and middle-income countries by identifying and supporting established local researchers, local manufacturers and clinical trial sites. Existing clinical trial support capacity and trial platforms will be made available. This approach will ensure optimal data collection, management, safety and analytical capacity.
An unprecedented range of experts
The coalition brings together an unprecedented range of health experts from public sector research institutes, ministries of health, academia, not-for-profit research and development organizations, NGOs, international organizations and donors, all committed to finding solutions to address VIDOC-19 in resource-constrained areas. The majority of these experts come from low- and middle-income countries.
An important research response on VIDOC-19 has already been put in place through the SOLIDARITY study led by the World Health Organization (WHO), an unprecedented global effort.
Nevertheless, the authors found that of the nearly 600 registered clinical studies on COVID-19, very few are planned in resource-limited areas. The authors are committed to sharing their technical expertise and clinical research capabilities to accelerate research on COVID-19 in these areas.
It is clear that this challenge of unparalleled magnitude cannot be met by any one organization alone. The coalition will facilitate a coordinated approach to ensure that data from all regions is collected in a similar manner, pooled and shared in real time. This will enable countries and WHO to make rapid evidence-based policy and practice decisions.
"We welcome the creation of this coalition, which builds on existing multinational and multidisciplinary expertise in conducting clinical studies in resource-constrained areas, and will assist WHO in its role of coordinating the global response to VIDOC-19, "says Dr. Soumya Swaminathan, Chief Scientist of the World Health Organization. "Although the epicentre is currently elsewhere, we must prepare now for the consequences of this pandemic in areas with more limited resources, or we risk losing many more lives. »
Coalition members are calling for specific commitments to ensure that resource-constrained areas have access to new and effective treatments as soon as possible, and that they are affordable and easily accessible.
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To date, 70 organizations are part of the coalition and a call has been made for other institutions willing to share their existing capacities to join them.
Current Signatories :
- Noor Hisham Abdullah, Ministry of Health, Malaysia ;
- Marcelo Claudio Abril, Mundo Sano Foundation, Argentina ;
- Ashenafi Tazebew Amare, University of Gondar, Ethiopia ;
- John H Amuasi, the African coaLition for Epidemic Research, Response and Training (ALERRT), Ghana;
- Prasert Auewarakul, Mahidol University, Thailand ;
- Augustin Augier, ALIMA, France ;
- Manica Balasegaram, GARDP, Switzerland ;
- Emmanuel Baron, Epicentre, France;
- Daniel G. Bausch, UK Public Health Rapid Support Team & London School of Hygiene & Tropical Medicine, UK ;
- Philip Bejon, KEMRI-Wellcome Trust Research Programme, Kenya ;
- Anders Björkman, Karolinska Institutet, Sweden ;
- Catharina Boehme, FIND, Switzerland ;
- Maria Elena Botazzi, Baylor College of Medicine, US A;
- Joel G Breman, American Society of Tropical Medicine and Hygiene (ASTMH), USA ;
- Pedro Cahn, Huesped Foundation, Argentina ;
- Gail Carson, International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), UK ;
- Roberto Chuit, Argentina National Academy of Health, Argentina;
- John Clemens, icddr,b, Bangladesh;
- Stewart Cole, Pasteur Institute, France;
- Nick Day, Mahidol Oxford Tropical Medicine Research Unit, Thailand;
- Arjen Dondorp, Critical Care Asia Network, Mahidol Oxford Tropical Medicine Research Unit, Thailand ;
- Paul Farmer, Harvard Medical School, USA;
- Jeremy Farrar, Wellcome, UK ;
- Abebaw Fekadu, CDT-Africa, Addis Ababa University, Ethiopia ;
- Antoine Flahault, Institute of Global Health, University of Geneva, Switzerland ;
- Patricia Garcia, Universidad Peruana Cayetano Heredia, Peru;
- Steven Gordon, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Malawi ;
- Anastasia Guantai, University of Nairobi, Kenya ;
- Philippe J Guerin, Infectious Diseases Data Observatory (IDDO), University of Oxford, UK ;
- Abraham Hodgson, Ghana Health Service, Ghana ;
- Peter Horby, ISARIC & the African Coalition for Epidemic Research, Response and Training (ALERRT), UK ;
- Peter Hotez, Baylor College of Medicine, USA;
- Muntaser Ibrahim, Institute of Endemic Diseases, University of Khartoum, Sudan ;
- Chikwe Ihekweazu, Nigeria Centre for Disease Control, Nigeria ;
- Timo Jaeger, DZIF German Center for Infection Research, Germany ;
- Jean Jannin, Société Francophone de Médecine Tropicale et Santé Internationale, France ;
- Gagandeep Kang, Translational Health Science and Technology Institute of India, India ;
- Marie-Paule Kieny, Drugs for Neglected Diseases initiative, Switzerland ;
- Yeri Kombe, KEMRI, Kenya;
- Hans-Georg Kraeusslich, DZIF German Center for Infection Research, Germany ;
- David Lalloo, Liverpool School of Tropical Medicine, UK ;
- Trudie Lang, The Global Health Network, UK ;
- Ramanan Laxminarayan, Center for Disease Dynamics, Economics & Policy, USA ;
- Honorati Masanja, Ifakara Health Institute, Tanzania;
- Marcela Mercado, Instituto Nacional de Salud de Colombia, Colombia ;
- Hassan Mshinda, Botnar Foundation, Tanzania;
- Joia Mukherjee, Partners in Health, USA ;
- Trevor Mundel, Bill & Melinda Gates Foundation, USA ;
- Jean-Jacques Muyembe, National Institute for Biomedical Research, Democratic Republic of Congo ;
- Barnabas Nawangwe, Makerere University, Uganda ;
- Francine Ntoumi, Pan-African Network for Rapid Research, Response, Relief and Preparedness for Infectious Disease Epidemics (PANDORA-ID-NET), Fondation Congolaise pour la Recherche Médical, Brazzaville, Republic of Congo ;
- Marta Ospina, Instituto Nacional de Salud de Colombia ;
- Michael Parker, ETHOX Centre, University of Oxford, UK ;
- Bernard Pécoul, Drugs for Neglected Diseases initiative, Switzerland ;
- Antonio Plasència Taradach, ISGlobal, Spain ;
- Richard Price, Menzies School of Health Research, Australia ;
- David Reddy, Medicines for Malaria Venture, Switzerland;
- John Reeder, UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), Switzerland ;
- Philip J Rosenthal, UCSF, USA ;
- John Arne Røttingen, Norwegian Research Council, Norway ;
- Fred Siyoi, Kenya Pharmacy & Poisons Board, Kenya ;
- Munir S. Skaf, University of Campinas, Brazil ;
- Nathalie Strub-Wourgaft, Drugs for Neglected Diseases initiative, Switzerland ;
- Marcel Tanner, Swiss Academy of Arts and Sciences, Switzerland ;
- Guy Thwaites, Oxford University Clinical Research Unit, Vietnam ;
- Faustino Torrico, CEADES Foundation, Bolivia ;
- Nísia Trinidade Lima, Fundação Oswaldo Cruz (Fiocruz), Brazil ;
- Jürg Utzinger, Swiss Tropical and Public Health Institute, Switzerland ;
- George M Varghese, Christian Medical College, Vellore, India;
- Nicholas J. White, Mahidol Oxford Tropical Medicine Research Unit, Thailand ;
- Marc-Alain Widdowson, Institute of Tropical Medicine, Belgium ;
- Charles S Wiysonge, South African Medical Research Council, South Africa ;
- Tassew Woldehanna, Addis Ababa University, Ethiopia ;
- Katharine Wright, Nuffield Council of Bioethics, UK ;
- Yazdan Yazdanpanah, REACTing & INSERM, France.
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