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Justin Davis - MedicReS World Congress 2013

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Why Good Medical Research?
Dr Justine Davies
Executive editor
The Lancet

Published in: Health & Medicine, Business
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Justin Davis - MedicReS World Congress 2013

  1. 1. 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 Davies Executive editor The Lancet
  2. 2. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
  3. 3. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey 1847 Hablot Knight-Browne
  4. 4. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey Satisfaction
  5. 5. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey Altruism
  6. 6. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
  7. 7. 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
  8. 8. 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
  9. 9. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
  10. 10. 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
  11. 11. 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
  12. 12. 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
  13. 13. 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 • ..........
  14. 14. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey “85% of research is wasteful or inefficient”
  15. 15. 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)
  16. 16. 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?’!
  17. 17. 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
  18. 18. 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
  19. 19. 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’
  20. 20. 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
  21. 21. 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
  22. 22. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey How to get better! • Researchers • Authors • Funders • Reviewers • Editors • Publishers • Readers • Shared responsibility!
  23. 23. 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
  24. 24. 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
  25. 25. 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!)
  26. 26. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey Protocol • SPIRIT guidelines for protocol
  27. 27. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
  28. 28. 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)
  29. 29. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
  30. 30. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
  31. 31. 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
  32. 32. 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
  33. 33. 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
  34. 34. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey Publish it well!
  35. 35. 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
  36. 36. 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)
  37. 37. 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?
  38. 38. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey CONSORT
  39. 39. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
  40. 40. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
  41. 41. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey Journals
  42. 42. 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)
  43. 43. 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.....)
  44. 44. 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”
  45. 45. 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’
  46. 46. 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
  47. 47. 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?
  48. 48. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey
  49. 49. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey Comments
  50. 50. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey COPE
  51. 51. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey Funders
  52. 52. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey Open access?
  53. 53. 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
  54. 54. 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
  55. 55. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey Research in reality...
  56. 56. 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
  57. 57. MedicReS Good Clinical Research CME June 7-8 2013 | Istanbul Turkey How good medical research Copyright: Scoutsandstilettoes

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