About Dr. Tom Jefferson
Dr. Tom Jefferson is a Medically trained epidemiologist with extensive experience of HTA and handling huge datasets, including regulatory dossiers, clinical data synthesis, systematic reviews, health economics studies, meta-analysis within medical devices and pharmaceutical companies. Have carried out health economics modelling and scholarly work in the past and have a firm grip of regulatory processes in EU. Member of Cochrane and EUNeHTA. Tom is a Senior Associate Tutor at the University of Oxford, a researcher at the Nordic Cochrane Centre and former scientific coordinator for the production of HTA reports on non-pharmaceuticals for Agenas, the Italian National Agency for Regional Healthcare.
As a founding member of RIHTA (Italian Regional HTA network), Tom has an extended network of contacts. Tom was scientific lead for the European EUNeHTA Joint Action 2 (Workpackage 4 – devices and diagnostics) project (2012-2015). This involved coordinating some 70 researchers from 28 agencies from 23 countries (from Estonia to Bulgaria, to Greece and Sweden). Tom carried out the same role for the previous EUNeHTA project (Joint Action 1 or JA1 with the European Commission).
Tom is an occasional peer reviewer for JAMA, BMJ, Lancet, CMAJ, New England Journal of Medicine and had co-authored two books and two Cochrane reviews on peer review (H-58).
RELEVANT ACADEMIC & PROFESSIONAL QUALIFICATIONS
MEDALS & DECORATIONS
RECENT And PRESENT ACTIVITIES
Unitl November 2019 Dr. Tom Jefferson provided scientific supervision for the Agenas (Agenzia per i Servizi Sanitari Regionali) HTA programme for non-pharmaceuticals. Agenas is an agency of the Italian MoH. Part of his work entailed supervising a group of 10 researchers and taking responsibility for designing, devising and carrying out HTA and Horizon Scanning assessments. Tom was scientific lead for the European EUNeHTA Joint Action 2 (Workpackage 4 – devices and diagnostics) project (2012-2015, see below). The EUNeHTA Collaboration is a network of European public agencies producing structured HTA information for national use. In 2021 the Collaboration should become a permanent network funded by the Commission.
Tom was also scientific coordinator for Workpackage 4 which assessesed non pharmaceutical interventions, such as in vitro tests. This involved coordinating some 70 researchers from 28 agencies from 23 countries (from Estonia to Bulgaria, to Greece and Sweden). The project started in 2012 and was completed in 2015. He carried out the same role for the previous EUNeHTA project (Joint Action 1 or JA1 with the European Commission). Until November 2019 he was a member of two different workpackages and a reviewer for two projects in these workpackages as part of the EUNeHTA JA3.
Tom co-developed a methodology for synthetising evidence of effectiveness, efficiency, safety and resource utlisation using regulatory information and data from different sources, both regulatory and open source. This activity was initially funded by NIHR UK until mid-2015, then the Cochrane Methods Innovations Fund (MIF), NIHR again and since 2016 the Cochrane Nordic Centre. The MIF project was a collaboration to draft advice of when and how to include regulatory material in Cochrane reviews.
He is developing this work further by streamlining the use of regulatory data and its incorporation into user friendly, timely reviews.
As part of a team in the Nordic Cochrane Centre Tom Jefferson carried out a systematic review of HPV vaccines based on regulatory documents. The evidence set for the review was assembled by them from a variety of sources into an Index of the human papillomavirus (HPV) vaccine industry clinical study programmes and non-industry funded studies, shortly to be published. At present they are developing the same reviews further with the complete regulatory dataset released by Health Canada after a court case.
Since 2015 Tom is a Fellow of the Centre for Evidence Based Medicine of the University of Oxford, in the UK. He is now Senior Clinical Tutor on the Complex Reviews Module of the MSc in Evidence Based Health course.
He is a Visiting Professor Institute of Health & Society at the Faculty of Medicine of Newcastle University (2019-2021).
With the 3 other Cochrane colleagues Tom was a co-investigator in a John and Laura Arnold Foundation grant for development of a RIAT support centre (2017-2020).
RIAT stands for Restoring Invisible and Abandoned Trials. In short, RIAT is a mechanism that enables researchers to address two long-standing problems in the medical literature: non-publication of trials and misreporting. Their concept was first outlined here: http://www.bmj.com/content/346/bmj.f2865
The RIAT Support Center will help accelerate the correction of the scientific record of clinical trials by making it more accurate and more complete.
Finally, with the help of the Cochrane Central Editorial Unit they stabilised of their three long-standing influenza vaccine reviews. These were released in January 2018.
Dr. Tom Jefferson’s activity line of regulatory data started with updating of Cochrane review A159 (Neuraminidase Inhibitors for influenza). A159 is currently based exclusively on regulatory information (essentially clinical study reports – CSRs from EMA and comments by FDA and PMDA – about 150K pages in all).
The story is told in:
David Payne. Tamiflu: the battle for secret drug data. BMJ 2012;345:e7303 doi: 10.1136/bmj.e7303 (Published 29 October 2012). http://www.bmj.com/content/345/bmj.e7303
The pioneers of transparency. BMJ 2015;350:g7717 (Published 02 Jan 2015)
He was a member of EMA’s Clinical Trials Advisory Group 2 (CTAG2).
Tom was (2018-21) on the editorial board of BMJ Evidence Based Medicine (BMJ EBM).
He 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).
Tom currently teach on the Complex Reviews module of the MSc in Evidence Based Health Care at Oxford University and currently supervising to MSc students. This involves reviews of regulatory data, economic studies, diagnostic studies, qualitative studies and IPI meta-analyses.
He is a member of the WHO COVID-19 Infection Prevention and Control Research Working Group.
Since 2020, Tom has collaborated with the Centre for Evidence Medicine to clarify modes of transmission of SARS CoV-2: https://www.cebm.ox.ac.uk/research/transmission-of-sars-cov-2
Tom is currently developing a Hierarchical Framework for Assessing Transmission Causality of Respiratory Viruses: Focus on SARS-CoV-2