This document discusses key considerations for clinical research design such as having a clear research question, selecting an appropriate design that best answers the question, considering feasibility factors, ensuring the work is interesting, relevant, novel, and ethical. It provides examples of common research designs like randomized controlled trials, surveys, qualitative research, and systematic reviews. It highlights common mistakes like having an overly ambitious project or deciding on methods before the research question. The conclusion emphasizes having a clear research question to guide design, methods, and getting necessary support and approvals.

1. Clinical Research Design
Roger Watson

2. Clinical Research Design
• The best design to answer the research question
• Feasibility
• Interest
• Relevant
• Novelty
• Ethical

3. • The best design to answer the
research question

4. Common misconceptions
• Some designs are better than other
• Not true
• Need to select appropriate designs to match problems
• Some methods are better than others
• Not true
• Need to select appropriate methods to match problems
• Topical issues are better or more easily published
• Not true
• Editors and examiners want to see good research

5. Common problems
• Lack of focus
• Decide what your research question is and stay with it
• Lack of a clear research question
• Don’t proceed until you have one
• Going too quickly
• Take your time in the early stages of a project
• You must try to avoid changing topic of changing designs

6. See the ‘gap in the wall’

7. Developing a research question
A clear statement in the form of a question of what you set out to
investigate, eg:
• Does intervention A work better than intervention B?
• What are the most common long-term complications of contracting COVID-
19?
• What is the patient experience of attending a nurse-led care clinic?
• What are the most effective treatments for COVID-19?

8. Research design
• Quantitative
• Randomised controlled trials
• Surveys
• Cross-sectional
• Longitudinal
• Qualitative
• Ethnography
• Grounded theory

9. Research methods
• Quantitative
• Randomised controlled trials
• Define primary outcome measure and data collection method
• How will randomisation be achieved?
• How will blinding be assured?
• How will sample size be calculated?

10. Research methods (contd.)
• Quantitative (contd.)
• Surveys
• Questionnaires
• Postal
• Telephone
• Internet
• Observations
• Sample size considerations
• Sampling procedures

11. Design
Cross-sectional
Longitudinal

12. Cross-sectional
Advantages
• relatively easy to conduct
Disadvantages
• limited information obtained

13. Longitudinal
Advantages
• very informative
Disadvantages
• relatively hard to conduct

14. Types of longitudinal studies
Trend
• same population (eg population of Hong Kong)
• not same people
Cohort
• same sample (eg nursing class of 2010)
• not necessarily the same people
Panel
• same sample (eg nursing class of 2010)
• same people

15. Types of longitudinal studies
Trend
• very informative about trends
• not very informative about people
Cohort
• quite informative about trends
• quite informative about people
Panel
• least informative about trends
• most informative about people

16. Types of longitudinal studies
Trend
• relatively easy to conduct
• sampling is easy
Cohort
• harder to conduct
• quite vulnerable to attrition
Panel
• Very hard to conduct
• Very vulnerable to attrition

17. Research methods (contd.)
• Qualitative
• Interviews
• Focus groups
• Recording
• Transcribing

18. Matching research designs with
research questions

19. Does intervention A work better than
intervention B?
• Experiment

20. What are the most common long-term
complications of contracting COVID-19?
• Survey

21. What is the patient experience of attending a
nurse-led care clinic?
• Qualitative
• Mixed methods (quantitative & qualitative)

22. What are the most effective treatments for
COVID-19?
• Systematic review (& meta-analysis)

23. • Design considerations

24. Experiment
• Required sample size
• Effect size estimation
• Recruitment
• Contamination
• Clustering
• Blinding

25. Survey
• Sample size
• Recruitment
• Attrition
• Survey instrument
• Survey platform

26. Qualitative
• Time
• Volume of data

27. Mixed methods (quantitative & qualitative)
• All the problems of survey and qualitative designs
• Which mixed methods design to use

28. Systematic review (& meta-analysis)
• More time consuming than anticipated – always
• Possibility of a nil return
• Retrieving articles
• Evaluating quality of articles

29. • Feasibilty

30. Common mistakes
• Wanting to change the world
• You are unlikely to
• Your project will be too ambitious
• Setting out to ‘prove’ something
• This is philosophically flawed
• And research ‘proves’ nothing
• Deciding on your method first
• You need to be clear on a research question
• Your methods should then follow

31. Issues affecting feasibility
• Will you have time?
• How long will data collection take?
• How long will it take to obtain permission?
• Will you obtain permission?
• Is the clinical area committed to the work?
• Do you envisage ethical problems?
• Can you recruit participants?
• What is the incidence/prevalence of the issue?
• Can potential participants give consent?

32. Interest

33. What do you want to get out of a research
project?
• Personal
• Achievement
• Ambition
• Altruistic
• Improve lives
• Professional
• Status
• Recognition
• Academic
• MSc/PhD

34. Relevant

35. Is anyone interested in your proposal?
• Are you interested?
• If not, then you will be less committed to the work
• Can you enthuse others about the work (you may need their help!)?
• Is the issue of interest to your hospital?
• It should make life easier if it is
• But beware of ‘stepping on toes’
• Is the issue of national importance?
• This will also make life easier
• There is the potential for financial support
• You should check to see if there are relevant national priorities

36. Novelty

37. Is the work novel?
• It does not have to be
• Replication is a vital aspect of clinical research
• Replication provides you with a ‘ready made’ design
• But you will have to justify doing a replication study
• If the work is novel
• You need to be sure it is before you claim it is
• You need to explain why it is necessary

38. Ethical

39. Is the work ethical?
• Can you envisage any ethical problems?
• Try to anticipate ethical issues
• What are the local ethics procedures?
• How long do they take?
• Expect at least one revision

40. Study registration

42. Checklist

43. Trial registration

50. Conclusion

51. Conclusion
• There is no best design
• Have a clear research question
• This will dictate
• Design
• Methods
• Analysis
• Ethics
• Every methods has its drawbacks
• You have to be interested in the project
• Others need to be interested to provide support
• Anticipate ethical issues

52. r.watson@hull.ac.uk
0000-0001-8040-7625
@rwatson1955