How can Open Science and responsible medical research meet the challenge of improving health? Trish Groves Editor-in-chief, BMJ Open and Honorary deputy editor, The British Medical Journal RRI Tools Final Conference - Brussels, 21-22 November 2016 PLENARY SESSION: Facing the societal challenges of our time

1. RRI Tools Final Conference, 21-22 November 2016, Brussels
Facing the societal challenges of our time:
How can Open Science and responsible medical
research meet the challenge of improving health?
Dr Trish Groves, BMJ
Twitter/@trished

2. |
RRI Tools Final Conference, 21-22 November 2016, Brussels
Competing interests
I’m editor in chief of BMJ Open and director of academic outreach at
BMJ (BMJ Publishing Group), owned by the British Medical Association
(BMA). I’ve served on the council of the international Committee on
Publication Ethics (COPE).
Part of the revenue for BMJ comes from drug & device manufacturers
through advertising, reprint sales, & sponsorship. The BMJ (British Medical
Journal) and BMJ Open are open access journals that charge article
publishing fees for research. I’m also editorial lead for the BMJ Research to
Publication eLearning programme (by subscription), which is in the RRI
Toolkit. My annual bonus scheme is based partly on the overall financial
performance of both BMJ and BMJ Research to Publication.
| Facing the societal challenges of our time

3. |
RRI Tools Final Conference, 21-22 November 2016, Brussels
What I’ll cover
• why medical research needs to open up
• how open can clinical research be, given need for
clincial confidentiality and privacy?
• what we can all do to ensure that medical research
is responsible, reproducible, and able to improve
health?
| Facing the societal challenges of our time

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RRI Tools Final Conference, 21-22 November 2016, Brussels
| Facing the societal challenges of our time

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RRI Tools Final Conference, 21-22 November 2016, Brussels
| Facing the societal challenges of our time
Continuing
challenge:
health inequalities
between and
within member
states

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RRI Tools Final Conference, 21-22 November 2016, Brussels
Clinical trials: answering the right questions?
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23
397
689
29
332
89
307
20
74
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
JLA patient-clinician
Priority Setting
Partnerships
Registered non-
commercial trials
Registered
commercial trials
Education and training, service
delivery, psychological, physical,
exercise, complementary, diet,
other
Radiotherapy, surgery and
perioperative, devices, and
diagnostic
Drugs, vaccines and biologicals

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RRI Tools Final Conference, 21-22 November 2016, Brussels
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Tackling research waste:
REWARD Alliance http://researchwaste.net/about/

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RRI Tools Final Conference, 21-22 November 2016, Brussels
Was stockpiled oseltamivir for
swine flu a white elephant?
The UK Department of Health
spent £424m on oseltamivir
(Tamiflu) for the H1N1
pandemic, then wrote off 6.5
million units worth £74m
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RRI Tools Final Conference, 21-22 November 2016, Brussels
Review of [eventually] shared clinical trial data
• substantial problems with the design, conduct, reporting
and availability of information from many of the trials
• no evidence of reductions in hospitalisation, nor of serious
influenza complications in either adults or children
• small but clinically important increase in harms (nausea,
vomiting, psych events) in oseltamivir vs placebo groups
| Facing the societal challenges of our time
Jefferson T et al. Cochrane Database of Systematic Reviews 2014,
Issue 4. Art. No.: CD008965

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RRI Tools Final Conference, 21-22 November 2016, Brussels
Access to patient-level data from clinical trials
“Data sharing could advance scientific discovery and
improve clinical care by maximizing knowledge
gained from data collected in trials, stimulating new
ideas for research, and avoiding unnecessarily
duplicative trials.
However, to reduce potential harms, policies are
needed to protect the privacy and consent of
participants, the validity of analyses, the investment
of funders and sponsors, and the academic
recognition of investigators.” U.S. Institute of Medicine, 2015
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RRI Tools Final Conference, 21-22 November 2016, Brussels
| Facing the societal challenges of our time
Benefits of open
science
As open as
possible, as closed
as needed
Horizon 2020

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RRI Tools Final Conference, 21-22 November 2016, Brussels
‘Data’ has different meanings
• data generated by studies (research projects) eg clinical
trials, population-based epidemiological studies
• data from routine clinical care (electronic health records)
• Big Data from biobanks, disease registries, population
statistics (national and EU), commercial data (eg insurance)
All shareable and resuable through responsible innovation:
• consent/opting in or out; ethics review; de-identification;
public understanding and debate; legislation
| Facing the societal challenges of our time

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RRI Tools Final Conference, 21-22 November 2016, Brussels
For debate:
What we can all do to ensure that medical research is
responsible, reproducible, and able to improve health?
• patients and the public
• academia and research funders
• health service providers
• publishers and tech experts
• legislators and policy makers
| Facing the societal challenges of our time

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RRI Tools Final Conference, 21-22 November 2016, Brussels
Thank you
tgroves@bmj.com
Twitter/@trished
| Facing the societal challenges of our time