justin davis - medicres world congress 2013

MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey

Why Good Medical Research?

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Research not published• Positive reporting bias• Negative studies go unpublished• Idea is never ‘put to bed’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

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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