Panel Session – Improving the Evidence for Systematic Reviews
Jon Brassey, Tom Jefferson, Gerald Gartlehner, Lars Hemkens
14:00 Wednesday June 22nd
Tom Jefferson – There is increasing evidence that trial literature is affected by reporting bias. The effects of such bias are seen at single study level and in systematic reviews of pharmaceuticals, biologics and devices. This situation undermines any evidence-based decision making and calls into question the use of most trial evidence for ethical decision-making. Lack of transparency and complex interplay between researchers, grant giving bodies, government and the pharmaceutical and publishing industries exasperate the situation and ultimately call into question the reliability of the EBM movement and its products.
Access to regulatory documents is likely to ameliorate the impact of reporting bias but at present complete sets of trial programme are not easily accessible. I will discuss the implications for each of the parties of this situation.
Evidence in the pub/college bar – Diary of a Tamiflu Research Parasite
Thursday June 23rd 18:15 – the Terrace Bar, Somerville College
Tom is the first author of the only Cochrane review based solely on unpublished on regulatory data.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 a 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. The emphasis on clinical study reports to the exclusion of publications was an attempt to address the problems of reporting bias which distorts much of literature on neuraminidase inhibitors.
Despite its notoriety, the review and its findings have not led to any detectable change in government policy to everyday use or stockpiling of the drugs but has spawned a series of indirect replies suggesting that independently reviewed complete evidence is not what high level decision makers want. They seem to prefer industry-sponsored reviews and observational studies to justify their decisions.
Tom will briefly list the responses in chronological order prompting discussion on the complex interplay between governments, public health bodies, industry and its key opinion leaders and journal editors.
As a Cochrane author and senior author of the RIAT declaration, Tom fits the definition of a research parasite recently proposed by Drs Longo and Drazen in the New England Journal of Medicine: “people who had nothing to do with the design and execution of the study but use another group’s data for their own ends, possibly stealing from the research productivity planned by the data gatherers, or even use the data to try to disprove what the original investigators had posited”.
Longo DL, Drazen JM. Data Sharing. N Engl J Med 2016; 374:276-277;
Best Paper of all time
Friday June 24th 13:30
Impact of oseltamivir treatment on influenza-related lower respiratory tract complications in hospitalizations
Laurent Kaiser, MD; Cynthia Wat, MBBS, MRCP; Tracy Mills, MSc; Paul Mahoney, MSc; Penelope Ward, MBBS; Frederick Hayden, MD
Tom Jefferson’s professional career has spanned two specialties: General Practice (1980–1985 and 1999 to date) and Public Health (since 1986). He is HTA scientific advisor to the Italian National Agency for Regional Health Services and lives in Rome.
Tom has been a contributor to The Cochrane Collaboration for over 20 years and is an author and editor for the Cochrane Acute Respiratory Infections (ARI) Group, a member of four other Cochrane Review Groups, two Methods Groups and was the co-ordinator of the Cochrane Vaccines Field and honorary research fellow to the UK Cochrane Centre 1999-2011. His main research interests are the application of systematic reviewing methods to studies of vaccines and antivirals with a variety designs (such as trials, economic evaluations and epidemiological studies), and peer review. Tom is a high-profile campaigner against pharmaceutical and other commercial companies influencing health policy. He received extensive media coverage in his criticism of the handling of the H1N1 (swine flu) outbreak by governments worldwide, which he argued was not evidence-based and is the lead author on the seminal work on antivirals and access to data.