Honorary Senior Research Fellow, CEBM
- Senior Associate Tutor, Department of Continuing Education
Tom Jefferson is a physician, researcher and campaigner for access to randomised controlled trial data.
For many years, Tom was denied access to regulatory data on which to base the Cochrane reviews he co-authors. At present, Tom is the first author of the only Cochrane review based solely on unpublished on regulatory data. The review of Neuraminidase inhibitors for preventing and treating influenza was seen as a major methodological development in the field of evidence-based medicine. The review challenged opinion across the regulatory, industrial and policy arenas, and has since been added as a landmark within the James Lind Library. It was the most accessed review in the Cochrane Library in 2014. The review was published in April 2014, both on the Cochrane Library and the BMJ, and was the culmination of a 4-year campaign to obtain a complete set of previously unseen 107 clinical study reports.
Currently Tom is stabilizing the suite of influenza vaccines reviews he is co-author of, and is co-authoring a review of regulatory evidence on HPV vaccines.
In addition Tom is taking part in the following:
- Interim guidance on the inclusion of clinical study reports and other regulatory documents in Cochrane Reviews funded by the Cochrane Methods Innovation Fund (MIF). This is a project aimed at improving the methodological quality of Cochrane reviews. The project aims to develop a background document on the rationale for including clinical study reports and other regulatory documents in Cochrane Reviews and advice on judging the priority of including such types of information in reviews (role PI).
- Jean Monnet Network Grant to create the Jean Monnet Health Law and Policy Network to address reporting bias, enhance regulatory transparency and introduce regulatory data in public health decision making (role: investigator).
- RIAT Support Center funded by the Laura and John Arnold Foundation. The RIAT (Restoring Invisible and Abandoned Trials) initiative outlines an accountable method for third-party researchers to publish unpublished trials and correct misreported trials when the original trial sponsors or investigators won’t. The Laura and John Arnold Foundation-funded RIAT Support Center will provide free-of-charge, practical aid and guidance to researchers that wish to RIAT, provide limited funding to selected RIAT teams, and engage in public advocacy efforts to achieve system level changes on clinical trial transparency (role Co-Investigator).
- Tom is an unpaid collaborator to the project Beyond Transparency in Pharmaceutical Research and Regulation led by Dalhousie University and funded by the Canadian Institutes of Health Research (2018-2022).
TJ was a recipient of a UK National Institute for Health Research grant for a Cochrane review of neuraminidase inhibitors for influenza. In addition, TJ receives royalties from his books published by Il Pensiero Scientifico Editore, Rome and Blackwells. TJ is occasionally interviewed by market research companies about phase I or II pharmaceutical products. In 2011-13, TJ acted as an expert witness in litigation related to the antiviral oseltamivir, in two litigation cases on potential vaccine-related damage and in a labour case on influenza vaccines in healthcare workers in Canada. He has acted as a consultant for Roche (1997-99), GSK (2001-2), Sanofi-Synthelabo (2003), and IMS Health (2013).In 2014 he was retained as a scientific adviser to a legal team acting on oseltamivir. TJ has a potential financial conflict of interest in the drug oseltamivir. In 2014-16, TJ was a member of three advisory boards for Boerhinger Ingelheim. He is holder of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews. TJ was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine. Between 1994 and 2013, TJ was the coordinator of the Cochrane Vaccines Field. TJ is a co-signatory of the Nordic Cochrane Centre Complaint to the European Medicines Agency (EMA) over maladministration at the EMA in relation to the investigation of alleged harms of HPV vaccines and consequent complaints to the European Ombudsman. TJ is co-holder of a John and Laura Arnold Foundation grant for development of a RIAT support centre (2017-2020) and Jean Monnet Network Grant, 2017-2020 for The Jean Monnet Health Law and Policy Network.