justin davis - medicres world congress 2013
TRANSCRIPT
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Why Good Medical Research?
Dr Justine DaviesExecutive editor
The Lancet
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
1847 Hablot Knight-Browne
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Satisfaction
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Altruism
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
• The key question is ‘how’ to do good medical research
• To answer this, one must first consider what good medical research is
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Number of clinical trials• Clinical trials.gov:• 150,000 trials• 185 countries• US is largest single area
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Other clinical trials registration databases
• Pan African Clinical Trials Registry• Australia and New Zealand Clinical Trials
Registry• Brazilian Clinical Trials Registry• ..........
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
“85% of research is wasteful or inefficient”
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Figure
Source: The Lancet 2009; 374:86-89 (DOI:10.1016/S0140-6736(09)60329-9)
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Asking the wrong question
This is the wrong time to be asking ‘why was this done?’!
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Research not published• Positive reporting bias• Negative studies go unpublished• Idea is never ‘put to bed’
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Biased reports
• Spin• Negative trials reported as positive• ‘trends’ emphasised• Secondary outcomes over hyped• Subgroup analyses over hyped
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
When the research gets to an editor’s in-box, it is too late
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
How to get better!
• Researchers• Authors• Funders• Reviewers• Editors• Publishers • Readers• Shared responsibility!
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Researchers and authors
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Ask the right question
• GET OUT OF THE LAB!• See the outside world • Ask the patients what is important• THINK LIKE AN EDITOR/REVIEWER
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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!)
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Protocol
• SPIRIT guidelines for protocol
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Trial registration
• ICJME• The Lancet will only consider trials that are
registered before recruitment of the first patient (The Lancet, May 2005)
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Ethics
• Doing a study in a way that will provide useful results
• Follow the protocol• Ethics approval• Patient consent• Patient confidentiality
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Publish it
• Ensure dissemination of results• Aim high (easier if previous steps have been
taken)• Discuss results at conferences
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Publish it well!
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Reporting guidelines
Check journal websites
CONSORT (RCT)
STROBE (cohort, case-control, cross-sectional)
PRISMA (systematic reviews and meta)
STARD (diagnostic accuracy reporting)
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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?
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
CONSORT
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Journals
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Publication ethics
• Authorship (what constitutes authorship)• Author conflict of interest• Role of the funding source• Plagiarism and text recycling• (Research misconduct)
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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.....)
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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”
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
•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’
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
• Ensure guidelines are adhered to• Uphold standards (plagiarism, etc)• Full and transparent peer review• Expediency • Research in context (comments)• Education• Approachability
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Research in context
What does it add?
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Comments
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
COPE
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Funders
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Open access?
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
• Take a longer term view• Consult with patients• Consult with physicians• Make the process easier for applicants
MedicReS Good Clinical Research CME June 6-7 2013 | Istanbul Turkey
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
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
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Research in reality...
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
Why good clinical research?
• Save the world• Relieve suffering• Improve society• Help individuals• Reduce pain
MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
How good medical research
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