Justin Davis - MedicReS World Congress 2013

MedicReS Good Clinical Research CME
June 7-8 2013 | Istanbul Turkey
Why Good Medical Research?
Dr Justine Davies
Executive editor
The Lancet

1847 Hablot
Knight-Browne

Satisfaction

Altruism

Clinical research spending
• $160 billion per year on biomedical research
• About 1/3 of this is on clinical research
• In the US the total spend is around $100
billion
• About half of spend is on clinical research

Clinical research funding in the UK
• approx £3 billion per year
• 1/3 of medical research funding (£1078
million per year) comes from charities
• 60% of this money comes from individuals

• The key question is ‘how’ to do good medical
research
• To answer this, one must first consider what
good medical research is

Good medical research
answers a relevant question
• The AIM of the research is paramount
• The study design should allow for the question
to be answered
• Leaving as few doubts as possible
• Or leading to a plan for further research

Number of clinical trials
• Clinical trials.gov:
• 150,000 trials
• 185 countries
• US is largest single area

Other clinical trials
registration databases
• Pan African Clinical Trials Registry
• Australia and New Zealand Clinical Trials
Registry
• Brazilian Clinical Trials Registry
• ..........

“85% of research is
wasteful or inefficient”

Figure
Source: The Lancet 2009; 374:86-89 (DOI:10.1016/S0140-6736(09)60329-9)

Asking the wrong question
This is the wrong time to be asking ‘why was this done?’!

The wrong question
• Of no use to patients (OA)
• Question has already been answered
• Proxy measures that don’t translate into
reliable clinical outcomes
• Time frame for grant won’t allow assessment
of relevant outcomes

Poor or inferior design
• Non blinded rct when could be blinded
• No power calculation
• Incorrect power calculation
• Outcome measures not validated
• Poor quality studies in meta-analyses
• Retrospective vs prospective cohort

Research not published
• Positive reporting bias
• Negative studies go unpublished
• Idea is never ‘put to bed’

Biased reports
• Spin
• Negative trials reported as positive
• ‘trends’ emphasised
• Secondary outcomes over hyped
• Subgroup analyses over hyped

When the research gets to an editor’s in-box, it
is too late

How to get better!
• Researchers
• Authors
• Funders
• Reviewers
• Editors
• Publishers
• Readers
• Shared responsibility!

Researchers and authors

Ask the right question
• GET OUT OF THE LAB!
• See the outside world 
• Ask the patients what is important
• THINK LIKE AN EDITOR/REVIEWER

Use the right design
• THINK LIKE AN EDITOR/REVIEWER!
• Write the paper before you write the grant
• Ask – will my methods give me an answer to
my question
• Go see a statistician (worth their weight in
gold!)

Protocol
• SPIRIT guidelines for protocol

Trial registration
• ICJME
• The Lancet will only consider trials that are
registered before recruitment of the first
patient (The Lancet, May 2005)

Ethics
• Doing a study in a way that will provide useful
results
• Follow the protocol
• Ethics approval
• Patient consent
• Patient confidentiality

Throughout the study
• Make every effort to recruit the required
number of patients
• Be meticulous
• Record data correctly
• Stick to the rules
• Don’t take short cuts

Publish it
• Ensure dissemination of results
• Aim high (easier if previous steps have been
taken)
• Discuss results at conferences

Publish it well!

What journals want
to know: IMRaD
• Introduction - Why did you do it?
• Methods - What did you do?
• Results - What did you find?
• Discussion – What might it mean.
• Abstract

Reporting guidelines
 Check journal websites
 CONSORT (RCT)
 STROBE (cohort, case-control, cross-sectional)
 PRISMA (systematic reviews and meta)
 STARD (diagnostic accuracy reporting)

Make it apparent to the editor (cover letter?)
• What is the overall finding?
• What are the strength and weaknesses?
• Why might the results be different from
previous research?
• What might the study mean for clinicians or
policy makers?
• What questions remain unanswered?
• What next?

CONSORT

Journals

Publication ethics
• Authorship (what constitutes authorship)
• Author conflict of interest
• Role of the funding source
• Plagiarism and text recycling
• (Research misconduct)

Inappropriate authorship
or non-authorship
The 3G’s
• Guests (invites him/herself)
• Gifts (authorship as a present – ie department
head...)
• Ghosts (or the disappearing author.....)

Conflict of interest
ICJME definition
“Conflict of interest for a given manuscript exists
when a participant in the peer review and
publication process – author, reviewer, or editor –
has ties to activities that could inappropriately
influence his/her judgment, WHETHER OR NOT
JUDGMENT IS IN FACT AFFECTED”

• Exists since 2008 (CrossRef, uses iThenticate)
• >126 publishers signed up (>50 000 journals)
• >25 Mio pieces of scientific literature in
database
• Takes test-text and matches it with published
pieces (does not check images, figures, or
tables)
plagiarism, duplicate publication,
and ‘self-plagiarism’

• Ensure guidelines are adhered to
• Uphold standards (plagiarism, etc)
• Full and transparent peer review
• Expediency
• Research in context (comments)
• Education
• Approachability

Research in context
What does it add?

Comments

COPE

Funders

Open access?

• Take a longer term view
• Consult with patients
• Consult with physicians
• Make the process easier for applicants

Research in an ideal world
Evidence of how to implement
intervention in practice
Large-scale trial evidence that
intervention works
Small-scale RCT evidence of
efficacy
Preclinical evidence of
intervention effect
Robust understanding of
disease pathology and risk
factors
Good understanding of normal
physiology

Research in reality...

Why good clinical research?
• Save the world
• Relieve suffering
• Improve society
• Help individuals
• Reduce pain

How good medical research
Copyright: Scoutsandstilettoes

Justin Davis - MedicReS World Congress 2013

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Justin Davis - MedicReS World Congress 2013