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** CANCELLED ** Centre for Primary Care Seminar –- Unpublished evidence to inform the safety and effectiveness of drugs by Prof Carl Heneghan and Dr Alex Hodkinson

Dates:29 November 2019
Times:13:00 - 14:30
What is it:Seminar
Organiser:Faculty of Biology, Medicine and Health
Who is it for:University staff, Current University students
Speaker:Professor Carl Heneghan, Dr Alex Hodkinson
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  • In category "Seminar"
  • In group "Policy event"
  • By Faculty of Biology, Medicine and Health
    • CANCELLED**

Unfortunately, due to unforeseen circumstances this seminar has been cancelled and will be rescheduled early in the new year and will confirm a new date soon.

Safe and effective drugs: the need to use all the available evidence to inform the effectiveness of commonly used medicines

The findings of clinical trials can sometimes be incomplete and misleading, with evidence that analyses and outcomes, including both efficacy and harms, may be reported selectively such that the true effects of treatments remain hidden. Consequently, those performing systematic reviews and meta-analyses may need to take additional steps to locate, appraise and synthesise missing or inadequately reported data in order to minimise the impact of reporting bias.

Clinical study reports (CSRs) which are produced for marketing authorisation applications; represent a far more complete, and untapped source of detailed randomised controlled trial data that are increasingly becoming publicly available. They have proven to be vital when evaluating both the efficacy and safety of clinical interventions and have even led to licenced products being withdrawn from the market. Past evidence and own experience indicate that CSRs should be considered as a basic unit for evidence synthesis to minimise the problem of reporting bias and to help inform regulatory decision-making.

In this seminar, Professor Carl Heneghan the director of both the National Institute for Health Research School for Primary Care Research Evidence Synthesis Working Group and Centre for Evidence-Based Medicine at the University of Oxford, will present results about his involvement in the widely recognised Cochrane commissioned review on Tamiflu that led to the discovery of 170,000 pages of CSRs to help assess claims about the efficacy of Tamiflu for treating patients with influenza type illnesses. https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD008965.pub4/abstract

He will also talk about the subsequent development of Alltrials campaign, and the current epidemic of publication and reporting bias that plagues much of the current research evidence in the public domain.

Dr Alex Hodkinson who is a Presidential Fellow at the University of Manchester, will present his research that has been looking at new methodology to assess patient safety in healthcare interventions in mental health specialisation. Specifically, he will present ongoing work that is looking to evaluate the safety of two controversial antipsychotic drugs in schizophrenia patients using CSRs from over 40 trials. Carl is also part of his supervisory team. He will also talk about his involvement with the CSR Cochrane Working Group and present a case study involving CSRs from his earlier research looking at the weight-maintenance drug orlistat.

All are welcome to attend but please register by emailing CPC.seminar.series@manchester.ac.uk

Speakers

Professor Carl Heneghan

Role: Director of NIHR SPCR Evidence Synthesis Working Group and Centre for Evidence-Based Medicine

Organisation: The University of Oxford

Dr Alex Hodkinson

Role: Presidential fellow

Organisation: The University of Manchester

Travel and Contact Information

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Lecture theatre A
University Place
Manchester

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Dr Salwa Zghebi, on behalf of the CPC Seminar Series Organising Committee

salwa.zghebi@manchester.ac.uk

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