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22 Sep 16 11 Jul 18

Governance

Day-to-day coordination of the TB PRACTECAL study is managed by the Project Management Team, housed in the Manson Unit at MSF UK.

Ethical and scientific rigor is maintained via a strong governance structure, including a Steering Committee and an external Scientific Advisory Committee consisting of world-renowned experts.

An external and independent Data and Safety Monitoring Board also ensure that the highest standards in patient safety and data reliability are met.

Ethics Oversight

Independent Ethics Review Boards (ERBs) are charged with protecting the rights, safety and wellbeing of clinical trial participants.

They review all aspects of a study before deciding whether it can go ahead or not. Before a site is allowed to start enrolling patients, the ERB will review all study-related materials including the protocol and patient materials. ERB’s also perform periodic reviews throughout the study’s duration.

TB PRACTECAL has been approved by the following independent Ethics Review Boards (ERB):

  • Médecins Sans Frontières/Doctors Without Borders (MSF) Ethics Review Board
     
  • London School of Hygiene and Tropical Medicine (LSHTM) Observational / Interventions Research Ethics Committee
     
  • Uzbekistan: Ethical Committee under Ministry of Health of the Republic of Uzbekistan
     
  • Belarus: Ethics Committee of the State Institution Republican Scientific and Practical Centre of Pulmonology and Tuberculosis
     
  • South Africa: Pharma Ethics Independent Research Ethics Committee

Key structures

Meet the project management team

Bern-Thomas Nyang’wa, Project Manager and Chief Investigator

Bern (MB; BS, MPH [Int]) is a Malawian public health doctor with extensive MDR-TB and international health experience. Dr Nyang’wa worked with MSF between 2004 and 2008 based in Malawi, Nigeria, Chad and Central African Republic.

Since 2009, he has advised TB programmes as part of the Manson Unit, MSF-UK with a focus on clinical and programmatic management of paediatric and drug resistant TB in Colombia, Georgia, Abkhazia, Uzbekistan, Tajikistan, Ethiopia and CAR.

He guest lectures at the London School of Health and Tropical Medicine and Nuffield Centre for International Health and Development and is an Honorary Clinical Lecturer  at University College London's Institue for Global Health.

Emil Kazounis, Clinical Trial Manager

Emil studied medical nutrition and public health and has seven years’ experience of clinical research in the UK NHS.

Emil previously setup and managed the UK’s first Blood Cancer Research - Clinical Trial Network and brings additional experience of managing EU Framework Programme projects and various in situ clinical research programmes in India and Cambodia.

Corinne Merle, Clinical Trialist

Based in the Special Programme for Research and Training in Tropical Diseases at the World Health Organisation (TDR-WHO), Corinne provides technical support for intervention and implementation research projects conducted in Low and Middle Income Countries.

Corinne is a medical doctor with significant experience as a clinical study coordinator for a phase III TB multicentre registration trial (OFLOTUB).

With over 15 years of international experience as a public health specialist Corinne’s current work includes Coordinating PI of the RAFA trial (TB/HIV treatment strategies - three parallel arms open labelled study), setting up and mentoring staff to run international multicentre clinical trials to GCP-ICH standards (Benin, Senegal, Guinea).

A trained an infectious diseases and public health specialist, she has a long history of lecturing and leading post-graduate study units for clinical trials, Good Clinical Practice, statistics and epidemiology at London School of Hygiene and Tropical Medicine (LSHTM), as well as in other institutions in Europe, Asia and Africa.

Raymond Omollo, Data Management Lead

Raymond has a PhD in Applied Statistics with over 10 years' experience in data management and statistics at various levels of clinical research.

He currently heads the Data and statistics centre of Drugs for Neglected Diseases Initiative (DNDi) Africa.

His current role providing data management oversight for a World Health Organisation multi-centric Buruli Ulcer GCP CLINICAL trial brings relevant expertise and experience in adapting data-bases to the needs and challenges of TB-PRACTECAL.

George Mokua Nyangweso, Data Manager

George joins DNDi ARO as a Senior Data Manager for MSF projects.

Most recently before joining DNDi, George worked as a Data Manager for the Kemri-Wellcome Trust Research Programme, Kilifi, Kenya, that involved managing data for multiple research projects ranging from longitudinal, cross-sectional to clinical trials.

Prior to that he worked for the University of Nairobi’s College of Health Sciences and Network Of AIDS Researchers In East And Southern Africa (Naresa) in varied capacities within the data management function.

George holds a BSc degree in Mathematics and Computer Science from Jomo Kenyatta University and brings on board over eight years of diversified service experiences in health research data management.

Michael Ochieng, Information Systems Manager

Michael is the Information Systems Manager at Drugs for Neglected Diseases initiative (DNDi) Africa Regional Office and is responsible for setting up and managing clinical data management systems.

He recently completed WHO/TDR career development fellowship program at Infectious Diseases Data Observatory (IDDO) based at the University of Oxford.

His fellowship Objective while at Oxford was to set up a pilot data sharing platform for Visceral Leishmaniasis.

Michael has over six years’ experience in clinical data management. He previously worked with KEMRI/Wellcome Trust Research Programme in Kilifi, Kenya as Systems and Data Manager and earlier on with Strathmore University in Nairobi, Kenya as a programmer.

He holds Bachelor of Science degree in Computer Technology from Jomo Kenyatta University of Agriculture and Technology and is currently finalising his Master of Science degree in Information Technology at Strathmore University.

David Trevino, Logistics support

David studied Architecture in Barcelona and has 22 years’ experience in logistics in MSF. He has worked in Georgia, Tanzania, Rwanda, Guatemala, Mexico, Sierra Leone, Kenya, Somalia, CAR, India, Pakistan, Colombia, Albania and Honduras.

He is currently responsible for first line support logistics to Chad, Russian Federation, Uzbekistan, Tajikistan and Papua New Guinea.

As a logistics advisor based in Berlin, he specifically supports MSF projects to plan technical set-up for medical operations, to deliver the required technical advice and to ensure that the supply chain is effective and efficient.

Seán King, Logistics Support

Seán worked in engineering (medical device development, automotive part design & automated manufacturing) for over 10 years before starting work with MSF in 2013 as a logistician. Since then he has worked in projects in Ethiopia, Sierra Leone and Pakistan.

Based in Amsterdam, Seán is responsible for supporting the logistics team in Uzbekistan and Tajikistan, ensuring MSF’s medical activities can continue 24/7.

In addition he provides technical support for biomedical and cold chain equipment used in MSF-Holland project locations.

Marion Coniin, Logistics Support

Marion Conijn has worked as a pharmacist assistant in several pharmacies. Prior to working for MSF, she worked as a Sales Support Product Coordinator at IDA Foundation, a non-for-profit organisation through which she was introduced to MSF, as they have worked intensively together for many years.

Three years ago, she joined MSF and since April 2017 she has been part of the Clinical Trial Team as Operational Procurement Officer.

She is responsible for order processing, purchasing and shipping of drugs, medical-, lab- and logistic supplies.

Coosje Tuijn, Laboratory/Biomed Field Support Advisor

Coosje holds an MSc degree in Applied Molecular Biology of Infectious Diseases from the LSHTM and has over 15 years’ experience in diagnostics, research and laboratory management.

She was employed and resided in Tanzania for three years before performing shorter term assignments in Rwanda, Uganda, Benin and India.

Prior to joining MSF she setup a local NGO laboratory for HIV prevention clinical trials and later took up the position of Laboratory Scientist at the Royal Tropical Institute of Biomedical Research. Within the TB-PRACTECAL team, Coosje supports the Logistics department with the laboratory and biomedical activities.

Katherine Fielding, Lead Statistician/LSHTM PI

A professor in Medical statistics and epidemiology at LSHTM, Katherine is a biostatistician with 20 years of post-doctoral experience including two years at the Centre for Disease Control and prevention (CDC) as visiting biostatistician and 15 years at LSHTM.

She has a 10 year history supervising PHD students for TB and HIV in biostatistics and epidemiology and been a biostatistician for eight TB-related studies.

Currently Katherine also sits on Data and Safety Monitoring Boards for three of the major current new TB drugs clinical trials (ReMox, Rifaquin, MAMS trial of 4 treatment regimens for new smear positive TB), is lead statistician in other large TB/HIV clinical trials and has an extensive publication history in TB.

Elizabeth Allen, Statistician

Elizabeth Allen is a professor in Medical Statistics and a member of the LSHTM Clinical Trials Unit management group.

She specialises in the design and analysis of cluster randomised and non-inferiority randomised controlled trials. 

Jo Sturgess, Statistician

Jo Sturgess is a Research Fellow based in the Department of Medical Statistics at the London School of Hygiene and Tropical medicine.

She collaborates in clinical trials and complex intervention evaluation studies providing expertise in data management, statistical analysis and clinical trials/GCP.

Clinical Trial Laboratory Coordinator (vacant)

Erin da Costa, Clinical Trial Pharmacist

Erin worked as a clinical hospital pharmacist for five years in Canada before pursuing her Masters of Public Health in Developing Countries at London School of Hygiene and Tropical Medicine (LSHTM). 

She joined MSF in 2010 as the Pharmacist Advisor in Amsterdam and was responsible for assuring quality supply and use of pharmaceutical products in all of MSF Holland's missions.

Catherine Berry, Medical Monitor

Catherine is an infectious diseases physician (FRACP) with over 12 years of clinical experience in internal medicine. Whilst completing a Masters in Public Health and Tropical Medicine, she joined MSF in 2014 working in Uzbekistan and Jordan.

She has extensive experience in research co-ordination as well as the care of MDR-TB patients.

Ilaria Motta, Medical Monitor

Ilaria is an infectious diseases physician with experience in managing HIV and TB infections in resource-limited settings.

She obtained a Diploma in Tropical Medicine and Hygiene (DTM&H) in 2011. She has recently completed her PhD project focusing on pharmacokinetics of TB drugs. 

In 2015 she worked for MSF in Central African Republic as a medical doctor.

Nathalie Lachenal, Pharmacovigilance officer

Nathalie has been working in pharmacovigilance on various therapeutic areas (neuro-/immunological diseases, oncology) in the pharmaceutical industry for seven years.

For the past six months, has set up a pharmacovigilance system for MSF to ensure appropriate detection, monitoring, follow-up and prevention of adverse drug reactions, for the TB-PRACTECAL and End-TB projects.

Emma Douch, Clinical Research Associate

Emma holds an MSc in Clinical Drug Development from Queen Mary University of London, with a focus on clinical research in emerging infectious disease outbreaks.

Prior to joining the TB-PRACTECAL team, Emma gained around six years’ experience within the UK NHS, working on a number of Oncology and Ophthalmology studies. She has previously held roles in trial coordination, data management and patient recruitment.

Emma Cunden, Clinical Trial Project Administrator

Emma studied Global Change: Environment, Economy and Development studies at Queen Mary, University of London. Prior to joining the MSF TB-PRACTECAL team, she worked on various humanitarian projects in Colombia, El Salvador, Spain and London.

Rosie Slater, Communications Advisor

Rosie joined MSF UK in 2017 and works as a press officer. She has a Masters in journalism from Goldsmiths and six years’ experience in NGO communications.

Steering Committee

Sidney Wong (chair), Medical Director, Operational Centre Amsterdam, MSF

Dr Jay Achar, HIV and TB Advisor, MSF

David Moore, Professor of Infectious Diseases and Tropical Medicine, LSHTM

Carl Mendel, Senior Vice President, Research and Development, TB Alliance

Koert Ritmeijer, Health Advisor Coordinator, Operational Centre Amsterdam, MSF

Bern-Thomas Nyang’wa, TB-PRACTECAL chief investigator/project manager, MSF

External Scientific Advisory

Robert Horsburgh (chair), Professor of Epidemiology, Boston University School of Public Health

Eric Nuermberger, Associate Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Johns Hopkins University

Graeme Meintjes, Associate Professor of Medicine and Infectious Diseases, University of Cape Town

Kathleen Eisenach, Professor of Pathology and Microbiology, University of Arkansas for Medical Sciences

Christian Lienhardt, Global TB Programme, World Health Organisation

Andrew Nunn, Associate Director and Chair of Infections Research Theme, Medical Research Council Clinical Trials Unit (MRC CTU) at University College London

Christoph Lange, Head of Clinical Infectious Diseases, Research Center Borstel, Leibniz Center for Biomedical Research

Data and safety monitoring board

Michael Hughes (Chair),  Professor of Biostatistics, Harvard School of Public Health

Askar Yedilbayev, Partners in Health Programme Director for Kazakhstan and Medical Officer for the Russian Federation

Johnstone Kumwenda, Professor of Internal Medicine, College of Medicine, University of Malawi

Dominique Larrey, Head of department (Hepatology, gastroenterology and liver transplantation); Montpellier School of Medicine

Todd Lorenz, Clinical Development/Medical Affairs/Scientific Licensing Consultant

Related publications

  1. Furin J, Alirol E, Allen E, Fielding K, Merle C, Abubakar I, Andersen J, Davies G, Dheda K, Diacon A, Dooley KE, Dravnice G, Eisenach K, Everitt D, Ferstenberg D, Goolam-Mahomed A, Grobusch MP, Gupta R, Harausz E, Harrington M, Horsburgh CR, Lienhardt C, McNeeley D, Mitnick CD, Nachman S, Nahid P, Nunn AJ, Phillips P, Rodriguez C, Shah S, Wells C, , du Cros P, Nyang'wa B. Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults. Int J Tuberc Lung Dis. 2016 Mar;20(3):290-4. doi: 10.5588/ijtld.15.0490.
     
  2. Brigden G, Nyang'wa BT, du Cros P, Varaine F, Hughes J, Rich M, Horsburgh CR Jr, Mitnick CD, Nuermberger E, McIlleron H, Phillips PP, Balasegaram M. Principles for designing future regimens for multidrug-resistant tuberculosis. Bull World Health Organ. 2014 Jan 1;92(1):68-74. doi: 10.2471/BLT.13.122028.
     
  3. Nyang'wa BT, Brigden G, du Cros P, Shanks L. Resistance to second-line drugs in multidrug-resistant tuberculosis. Lancet. 2013 Feb 23;381(9867):625. doi: 10.1016/S0140-6736(13)60341-4.
     
  4. Trial and Error’ Operational reflections on the set-up of a community engagement programme for a phase II-III clinical trial to identify new MDR-TB treatments in Uzbekistan. MSF Scientific Day 2016 poster link on F1000 site
     

Visit the ClinicalTrials.gov registry database

Clinical trial number is NCT02589782