With thanks

Acknowledgments

The work of the Good Clinical Trials Collaborative has been made possible by generous grants from Wellcome and the Bill & Melinda Gates Foundation.

Development of the guidance was led by the following groups: 

Good Clinical Trials Collaborative Secretariat

  • Professor Sir Martin Landray | Senior Lead
  • Nick Medhurst | Team Lead
  • Charlie Rowley | Project Manager
  • Ee Ching Tan | Communications Advisor

Former members

  • Nana Shimosako | Project Manager
  • Alice Barney | Coordinator 
  • Aisha Mazhar | Officer
  • Isabel Smith | Officer

With special thanks to

  • Christina Reith | Nuffield Department of Population Health, University of Oxford

Good Clinical Trials Collaborative Steering Group

  • Rob Califf | formerly Verily Life Sciences and Google Health
  • Mimi Darko | Food And Drugs Authority, Ghana
  • Jim Elliott | UK Health Research Authority
  • Jeremy Farrar | Wellcome Trust
  • Ian Hudson | Bill & Melinda Gates Foundation
  • Dorcas Kamuya | KEMRI-Wellcome Trust Research Programme
  • Kathryn Maitland | KEMRI-Wellcome Trust Research Programme
  • Vasee Moorthy | World Health Organization
  • Amrit Ray | Biohaven Pharmaceuticals
  • Nancy Roach | Fight Colorectal Cancer
  • Soumya Swaminathan | World Health Organization
  • Fergus Sweeney (Observer) | European Medicines Agency
  • Janet Woodcock (Observer) | U.S. Food & Drug Administration

Contributors

In acknowledging the contributions of the individuals named below, the Collaborative does not claim their endorsement of the guidance but wish to express its gratitude for having volunteered their expertise and time towards its development:

  • John H. Alexander | Duke Clinical Research Institute, Duke University 
  • Susana Almeida | Medicines for Europe 
  • Frank E. Baiden | Department of Clinical Research, London School of Hygiene and Tropical Medicine 
  • Sunita Sheel Bandewar | Vidhayak Trust;  Health, Ethics and Law Institute of FMES 
  • Trishna Bharadia  | Independent Patient Advocate 
  • Barbara E. Bierer  | Brigham and Women’s Hospital, Harvard Medical School 
  • Anders Bjartell | Skåne University Hospital and Lund University
  • Gillian Booth | University of Leeds
  • Devi Leena Bose | International AIDS Vaccine Initiative (IAVI) 
  • Louise Bowman | Nuffield Department of Population Health, University of Oxford
  • Marc Buyse | International Drug Development Institute (IDDI), Louvain-la-Neuve, Belgium
  • Marina Cardozo Vasco, PhD | Flutter Innovation
  • Nichapa Choengsamor | DSIL Global 
  • Adam Cohen | Leiden University Medical Centre
  • Sarah Collen | European Association of Urology
  • Rory Collins | Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU), University of Oxford 
  • Sabrina Comic-Savic | Trialspark 
  • Janet Darbyshire | University College London 
  • PJ Devereaux | McMaster University 
  • Martin Dreyling | LMU University Hospital, Department of Medicine III
  • John Eikelboom | David Braley Cardiac Vascular and Stroke Research Institute, Hamilton Health Sciences, McMaster University
  • M. Khair ElZarrad (Observer) | CDER – U.S. Food & Drug Administration
  • Ezekiel J. Emanuel | Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania
  • Jonathan Emberson | Nuffield Department of Population Health, University of Oxford
  • Marcela Fajardo-Moser | ERA-EDTA
  • Andrew J. Farmer | NIHR Health Technology Assessment Programme
  • Barbara Farrell | UK Trial Managers’ Network
  • Dean A. Fergusson | Ottawa Hospital Research institute
  • Morenike Oluwatoyin Folayan | Faculty of Health Science, Obafemi Awolowo University, Ile-Ife, Nigeria
  • Alan G Fraser | Cardiff University
  • Janet Frost | Independent Adviser
  • Christian Gisselbrecht | European Hematology Association
  • Jennifer Harris | Association of the British Pharmaceutical Industry
  • Richard Haynes | MRC Population Health Research Unit and Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford
  • Chris Hayward | Peninsula Clinical Trials Unit, University of Plymouth
  • J.M. den Heijer | Centre for Human Drug Research, Leiden
  • Kaustubh Joag | Centre for Mental Health Law & Policy, ILS, Pune
  • Pichet Kamolrungsantisuk | Medical Research Network for Social, Medical Research Foundation Thailand
  • Evelyne Kestelyn | Oxford University Clinical Research Unit (OUCRU)
  • Patricia Kingori | Nuffield Department of Population Health, University of Oxford
  • Carol Knott | Nuffield Department of Population Health, University of Oxford
  • Denis Lacombe | European Organisation for Research and Treatment of Cancer
  • Trudie Lang | The Global Health Network, University of Oxford
  • Roger J. Lewis | Berry Consultants, LLC, Austin, Texas
  • Anne S Lindblad | formerly The Emmes Company LLC
  • Amalee McCoy | Independent
  • Maisie McKenzie | Patient and Public Involvement and Engagement Adviser
  • Georgina McMasters | Independent Lay Adviser
  • Ann Meeker-O’Connell | formerly Vertex Pharmaceuticals
  • Usha Menon | MRC Clinical Trials Unit, Institute of Clinical Trials & Methodology, University College London
  • Janet Messer | Health Research Authority
  • Hamid Moradi | Associate Clinical Professor
  • Neetha Shagan Morar | HIV Prevention Research Unit, South African Medical Research Council (HPRU, SAMRC)
  • Briggs W. Morrison |Independent
  • Henry Mwandumba | Malawi Liverpool Wellcome Clinical Research Programme
  • Della Ogunleye | Independent Lay Adviser
  • Martin O’Kane | MHRA
  • Deepa Pandit | Centre for Mental Health Law and Policy, Indian Law Society, Pune
  • Michael Parker | Ethox Centre, Nuffield Department of Population Health, University of Oxford
  • Nicola Perrin | Independent
  • Nittaya Phanuphak | Institute of HIV Research and Innovation (IHRI)
  • Sheuli Porkess | Actaros
  • Ian Roberts | LSHTM
  • John Roberts | Independent Lay Adviser
  • Sara Román Galdrán | European Hematology Association
  • Michel Satya Naslavsky | Human Genome and Stem Cell Research Center, Biosciences Institute, University of São Paulo
  • Daniel I. Sessler | Michael Cudahy Professor & Chair, Department of Outcomes Research, Cleveland Clinic
  • Rachit Shah | Quicksand Design Studio Pvt. Ltd
  • Joseph Skhosana | Independent
  • Natalie Staplin | Nuffield Department of Population Health, University of Oxford
  • Kannan Subramaniam | Viatris
  • Jeremy Sugarman | Harvey M. Meyerhoff Professor of Bioethics and Medicine, Berman Institute of Bioethics and School of Medicine, Johns Hopkins University
  • Matthew R Sydes | MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology & BHF Data Science Centre with HDR UK
  • Wojciech Szczeklik | Jagiellonian University Medical College, Krakow
  • Pamela Tenaerts | Medable (formerly Clinical Trials Transformation Initiative)
  • Shaun Treweek | Health Services Research Unit, University of Aberdeen
  • Catherine Wandie | Matchboxology 
  • Christoph Wanner | European Renal Association-European Dialysis and Transplantation Association
  • Tanyaporn Wansom | IndependentNicholas J White | Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok
  • Scott Williams | Independent
  • Janet Wittes | WCG Statistics Collaborative