Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review

[1]  J. Higgins,et al.  Cochrane Handbook for Systematic Reviews of Interventions , 2010, International Coaching Psychology Review.

[2]  Michael Proschan,et al.  A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics. , 2019, The New England journal of medicine.

[3]  H. Goossens,et al.  “Advancing preparedness for clinical research during infectious disease epidemics” Nina Gobat, John Amuasi, Yazdan Yazdanpanah, Louise Sigfrid, Hugh Davies, John-Paul Byrne, Gail Carson, Christopher Butler, Alistair Nichol and Herman Goossens. ERJ Open Res 2019; 5: 00227-2018. , 2019, ERJ Open Research.

[4]  Herman Goossens,et al.  Advancing preparedness for clinical research during infectious disease epidemics , 2019, ERJ Open Research.

[5]  Colin Simpson,et al.  The UK's pandemic influenza research portfolio: a model for future research on emerging infections. , 2018, The Lancet. Infectious diseases.

[6]  H. Goossens,et al.  Preparedness for clinical research during pandemics: a perspective from the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) , 2018, The Lancet.

[7]  J. McGowan,et al.  PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation , 2018, Annals of Internal Medicine.

[8]  Wichor M Bramer,et al.  A systematic approach to searching: an efficient and complete method to develop literature searches , 2018, Journal of the Medical Library Association : JMLA.

[9]  H. Feldmann,et al.  Ebola: Lessons on Vaccine Development. , 2018, Annual review of microbiology.

[10]  P. Horby Improving preparedness for the next flu pandemic , 2018, Nature Microbiology.

[11]  D. Watson-Jones,et al.  EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country , 2018, Clinical trials.

[12]  A. Schuchat,et al.  Implementing a Multisite Clinical Trial in the Midst of an Ebola Outbreak: Lessons Learned From the Sierra Leone Trial to Introduce a Vaccine Against Ebola , 2018, The Journal of infectious diseases.

[13]  J. Lundgren,et al.  Rigorous Clinical Trial Design in Public Health Emergencies Is Essential , 2018, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[14]  Lauren Ancel Meyers,et al.  Preprints: An underutilized mechanism to accelerate outbreak science , 2018, PLoS Medicine.

[15]  S. Lees,et al.  "We are the heroes because we are ready to die for this country": Participants' decision-making and grounded ethics in an Ebola vaccine clinical trial. , 2018, Social science & medicine.

[16]  Tamba E. M’bayo Understanding West Africa’s Ebola Epidemic: Towards a Political Economy , 2018 .

[17]  P. Horby,et al.  Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic , 2017, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[18]  K. Hood,et al.  Talking to the people that really matter about their participation in pandemic clinical research: A qualitative study in four European countries , 2017, Health expectations : an international journal of public participation in health care and health policy.

[19]  S. Hodgson Understanding West Africa’s Ebola epidemic , 2017, Medicine, conflict, and survival.

[20]  P. P. Rosario,et al.  Ethical challenges for international collaborative research partnerships in the context of the Zika outbreak in the Dominican Republic: a qualitative case study , 2017, Health Research Policy and Systems.

[21]  L. Fernández-Luque,et al.  Controversial Ebola vaccine trials in Ghana: a thematic analysis of critiques and rebuttals in digital news , 2017, BMC Public Health.

[22]  Daniel J. Hurst Benefit Sharing in a Global Context: Working Towards Solutions for Implementation. , 2017, Developing world bioethics.

[23]  M. Lipsitch,et al.  Improving vaccine trials in infectious disease emergencies , 2017, Science.

[24]  E. Alirol,et al.  Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic , 2017, BMC medical ethics.

[25]  Marie Paule Kieny,et al.  WHO R&D Blueprint: a global coordination mechanism for R&D preparedness , 2017, The Lancet.

[26]  G. Keusch,et al.  Clinical trials during epidemics , 2017, The Lancet.

[27]  P. Maes,et al.  Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa , 2017, PLoS neglected tropical diseases.

[28]  S. Shrivastava,et al.  Strengthening research and development activities to effectively contain the epidemics of infectious diseases: World health organization , 2017 .

[29]  S. Shrivastava,et al.  Upscaling of interventions for the control of Echinococcosis and its associated complications , 2017 .

[30]  J. Pierson,et al.  Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency , 2017, The American journal of tropical medicine and hygiene.

[31]  S. Glismann,et al.  The ADVANCE Code of Conduct for collaborative vaccine studies. , 2017, Vaccine.

[32]  D. Wendler,et al.  The Guinea Phase III Ebola Vaccine Trial: Lessons for Research Ethics Review in Public Health Emergencies. , 2017, IRB.

[33]  N. Pollock,et al.  Evaluating Novel Diagnostics in an Outbreak Setting: Lessons Learned from Ebola , 2017, Journal of Clinical Microbiology.

[34]  B. Light,et al.  Time required to initiate outbreak and pandemic observational research☆☆☆ , 2017, Journal of Critical Care.

[35]  M. Molyneux New ethical considerations in vaccine trials , 2017, Human vaccines & immunotherapeutics.

[36]  H. Draper,et al.  A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines , 2017, PLoS ONE.

[37]  R. Peeling,et al.  ZikaPLAN: Zika Preparedness Latin American Network , 2017, Global health action.

[38]  Raffaella Ravinetto,et al.  Research Ethics Governance in Times of Ebola , 2016, Public health ethics.

[39]  D. Shaw,et al.  Publication ethics in public health emergencies , 2016, Journal of public health.

[40]  P. Horby,et al.  Modernising epidemic science: enabling patient-centred research during epidemics , 2016, BMC Medicine.

[41]  S. Lees,et al.  Power, fairness and trust: understanding and engaging with vaccine trial participants and communities in the setting up the EBOVAC-Salone vaccine trial in Sierra Leone , 2016, BMC Public Health.

[42]  K. Hood,et al.  Public attitudes towards research participation during an infectious disease pandemic: a qualitative study across four European countries , 2016, The Lancet.

[43]  P. Horby,et al.  Experimental Treatment of Ebola Virus Disease with Brincidofovir , 2016, PloS one.

[44]  C. Rivers,et al.  Make Data Sharing Routine to Prepare for Public Health Emergencies , 2016, PLoS medicine.

[45]  Robert Pinner,et al.  Implementing an Ebola Vaccine Study - Sierra Leone. , 2016, MMWR supplements.

[46]  L. Wehrlen,et al.  Beating the odds: Successful establishment of a Phase II/III clinical research trial in resource-poor Liberia during the largest-ever Ebola outbreak , 2016, Contemporary clinical trials communications.

[47]  E. Hwang,et al.  Coordinating funding in public health emergencies , 2016, The Lancet.

[48]  M. Kieny,et al.  Regulatory policy for research and development of vaccines for public health emergencies , 2016, Expert review of vaccines.

[49]  G. Leung,et al.  Toward a Common Secure Future: Four Global Commissions in the Wake of Ebola , 2016, PLoS medicine.

[50]  M. Kieny,et al.  On a path to accelerate access to Ebola vaccines: The WHO's research and development efforts during the 2014-2016 Ebola epidemic in West Africa. , 2016, Current opinion in virology.

[51]  S. Lees,et al.  Implementing a novel community engagement system during a clinical trial of a candidate Ebola vaccine within an outbreak setting , 2016 .

[52]  Annette Rid,et al.  Ethical Rationale for the Ebola "Ring Vaccination" Trial Design. , 2016, American journal of public health.

[53]  R. Murphy,et al.  Clinical Research and the Training of Host Country Investigators: Essential Health Priorities for Disease-Endemic Regions , 2016, The American journal of tropical medicine and hygiene.

[54]  A. Delamou,et al.  Multiple ethical review in North-South collaborative research: the experience of the Ebola-Tx trial in Guinea. , 2016, Indian journal of medical ethics.

[55]  Scott M Berry,et al.  A response adaptive randomization platform trial for efficient evaluation of Ebola virus treatments: A model for pandemic response , 2016, Clinical trials.

[56]  Christopher W Woods,et al.  Ebola clinical trials: Five lessons learned and a way forward , 2016, Clinical trials.

[57]  L. Moses,et al.  Clinical validation trial of a diagnostic for Ebola Zaire antigen detection: Design rationale and challenges to implementation , 2016, Clinical trials.

[58]  A. Levine Academics are from Mars, humanitarians are from Venus: Finding common ground to improve research during humanitarian emergencies , 2016, Clinical trials.

[59]  Tony Vangeneugden,et al.  Simulation-guided phase 3 trial design to evaluate vaccine effectiveness to prevent Ebola virus disease infection: Statistical considerations, design rationale, and challenges , 2016, Clinical trials.

[60]  M. Cavaleri,et al.  A viewpoint on European Medicines Agency experience with investigational medicinal products for Ebola , 2016, Clinical trials.

[61]  A. Abayomi,et al.  Taking the bull by the horns: Ethical considerations in the design and implementation of an Ebola virus therapy trial , 2015, Social Science & Medicine.

[62]  Nayha Sethi,et al.  Conducting research in the context of global health emergencies , 2016 .

[63]  Lawrence O Gostin,et al.  Will Ebola change the game? Ten essential reforms before the next pandemic. The report of the Harvard-LSHTM Independent Panel on the Global Response to Ebola , 2015, The Lancet.

[64]  T. Lang Ebola: Embed research in outbreak response , 2015, Nature.

[65]  John-Arne Røttingen,et al.  The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola , 2015, BMJ : British Medical Journal.

[66]  B. Haire,et al.  Stakeholders’ engagement with Ebola therapy research in resource limited settings , 2015, BMC Infectious Diseases.

[67]  Lauren Ancel Meyers,et al.  Statistical power and validity of Ebola vaccine trials in Sierra Leone: a simulation study of trial design and analysis. , 2015, The Lancet. Infectious diseases.

[68]  G. Apolone,et al.  Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa? , 2015, The Lancet Infectious Diseases.

[69]  G. Rodier,et al.  Ebola vaccines: keep the clinical trial protocols on the shelf and ready to roll out , 2015, The Lancet.

[70]  W. Lim,et al.  Blinded randomised controlled trial of low-dose Adjuvant Steroids in Adults admitted to hospital with Pandemic influenza (ASAP): a trial 'in hibernation', ready for rapid activation. , 2015, Health technology assessment.

[71]  L. Rosella,et al.  The ethics of sharing preliminary research findings during public health emergencies: a case study from the 2009 influenza pandemic. , 2014, Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin.

[72]  W. Lim,et al.  Randomised trials during a public health crisis, such as pandemic flu: a case study for a model of ‘off the shelf' ready-to-go trials , 2013, Trials.

[73]  J. Marshall,et al.  Participation of ICUs in Critical Care Pandemic Research: A Province Wide, Cross-Sectional Survey* , 2013, Critical care medicine.

[74]  Francis Collins,et al.  Research as a part of public health emergency response. , 2013, The New England journal of medicine.

[75]  J. Langley,et al.  Strategies for successful rapid trials of influenza vaccine , 2011, Clinical trials.

[76]  D. Cook,et al.  Costs Of Clinical Research Preparation For The H1N1 Pandemic In Canada: A Single Center, Multi-Site Analysis , 2011, ATS 2011.

[77]  D. Annane,et al.  Designing and conducting a randomized trial for pandemic critical illness: the 2009 H1N1 influenza pandemic , 2011, Intensive Care Medicine.

[78]  C. Simon,et al.  Ethical problems in conducting research in acute epidemics: the Pfizer meningitis study in Nigeria as an illustration. , 2010, Developing world bioethics.

[79]  C. Sprung,et al.  Early observational research and registries during the 2009–2010 influenza A pandemic , 2010, Critical care medicine.

[80]  C. Sprung,et al.  Clinical research ethics for critically ill patients: A pandemic proposal , 2010, Critical care medicine.

[81]  T. Walley,et al.  Research funding in a pandemic , 2010, The Lancet.

[82]  S. Faust,et al.  Expediting clinical trials in a pandemic , 2009, BMJ : British Medical Journal.

[83]  Samia Hurst,et al.  Research Ethics and International Epidemic Response: The Case of Ebola and Marburg Hemorrhagic Fevers , 2009 .

[84]  J. Farrar,et al.  The Southeast Asian Influenza Clinical Research Network: development and challenges for a new multilateral research endeavor. , 2008, Antiviral research.

[85]  Benjamin Jeffs,et al.  Treatment of Marburg and Ebola hemorrhagic fevers: a strategy for testing new drugs and vaccines under outbreak conditions. , 2008, Antiviral research.

[86]  E. von Elm,et al.  Full publication of results initially presented in abstracts. , 2007, The Cochrane database of systematic reviews.