Introductory Clinical Research
Wed at 3pm, lecture room on 1st floor Institute of Stomatology, RSU
Good clinical research requires four elements:
asking a clinically important question,
ensuring adequate methodological design,
conducting the research appropriately, and
transparent reporting of the results, allowing the assessment of the validity, replicability and relevance of the findings.
Aim
Clinical research requires handling specific concepts that allow the appropriate design, execution, analysis and dissemination of results for the security and benefit of patients.
The objective of this module is to provide the concepts and terms that allow understanding the terminology involved in the design of clinical studies.
When and where
Each Wednesday, 3-4pm EET, at the Institute of Stomatology, RSU
How
Each doctoral student should print, read and prepare a brief presentation (max 10 min) of the essential concepts of the week's paper using this template. The use of PowerPoint or similar is not allowed. A blackboard and marker are available.
The presenter will be selected at random at each session. After his/her presentation we will discuss any specific questions.
Join
Write me at sergio.uribe at rsu.lv
This week's reading
What care should I take when entering and managing data in a clinical investigation?
Broman, K.W., Woo, K.H., 2018. Data Organization in Spreadsheets. Am. Stat. 72, 2–10.
Wilkinson et al., 2016. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data 3, 160018.
Reading list
Before starting, general considerations to be taken into account
Schwab, Simon, et al. “Ten Simple Rules in Good Research Practice for Early Career Researchers.” OSF Preprints, 27 Nov. 2021. Web.s
Should we do this research, and if so, how do we do it?
Emanuel EJ, Wendler D and Grady C (2000) What makes clinical research ethical? JAMA: the journal of the American Medical Association 283(20): 2701–2711.
Lecture Ethics in Biomedical Research Playlist
Is all medical research important?
Chalmers I, Bracken MB, Djulbegovic B, et al. (2014) How to increase value and reduce waste when research priorities are set. The Lancet 383(9912): 156–165.
Macleod MR, Michie S, Roberts I, et al. (2014) Biomedical research: increasing value, reducing waste. The Lancet 383(9912): 101–104.
What are the types of research designs for answering questions in medicine?
Grimes DA and Schulz KF (2002) 01 An overview of clinical research: the lay of the land. The Lancet 359(9300): 57–61.
What are the key concepts for understanding the design and interpretation of medical studies?
Levin KA (2005) Study design II. Issues of chance, bias, confounding and contamination. Evidence-based dentistry 6(4): 102–103.
Balevi B and Abt E (n.d.) Statistics Tutorial Part II: Statistical and Clinical Significance.paperpile.com/app/p/82a084ca-4245-0bf3-ad9e-11cff63e259b
What are observational designs and what are they for?
Grimes DA and Schulz KF (2002) 02 Descriptive studies: what they can and cannot do. The Lancet 359(9301): 145–149.
Grimes DA and Schulz KF (2002a) 03 Bias and causal associations in observational research. The Lancet 359(9302): 248–252.
Grimes DA and Schulz KF (2002b) 04 Cohort studies: marching towards outcomes. The Lancet 359(9303): 341–345.
Schulz KF and Grimes DA (2002) 05 Case-control studies: research in reverse. The Lancet 359(9304): 431–434.
Grimes DA and Schulz KF (04/2005) 06 Compared to what? Finding controls for case-control studies. The Lancet 365(9468): 1429–1433.
What are experimental designs and what are they for?
Hulley (2013) Hulley Chapters 1 & 2. In: Hulley S: Cummings S: Browner W: Grady D: Newman T (ed.) Designing Clinical Research, pp. v–vi.
Farrugia P, Petrisor BA, Farrokhyar F, et al. (2010) Research questions, hypotheses and objectives. Canadian journal of surgery. Journal canadien de chirurgie 53(4): 278.
Pihlstrom BL and Barnett ML (2010) Design, operation, and interpretation of clinical trials. Journal of Dental Research 89(8): 759–772.
Braga LHP, Farrokhyar F and Bhandari M (2012) Practical Tips for Surgical Research: Confounding: What is it and how do we deal with it? Canadian journal of surgery. Journal canadien de chirurgie 55(2): 132.
Karanicolas PJ, Farrokhyar F and Bhandari M (2010) Blinding: Who, what, when, why, how? Canadian journal of surgery. Journal canadien de chirurgie 53(5): 345.
Pilot Studies: What are clinical pilot studies for?
Why does this treatment work in some patients only?
Redekop WK and Mladsi D (2013) The faces of personalized medicine: a framework for understanding its meaning and scope. Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research 16(6 Suppl): S4–9.
Glasziou PP and Irwig LM (1995) An evidence based approach to individualising treatment. BMJ 311(7016): 1356–1359.
What care should I take when entering and managing data in a clinical investigation?
Broman, K.W., Woo, K.H., 2018. Data Organization in Spreadsheets. Am. Stat. 72, 2–10.
Wilkinson et al., 2016. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data 3, 160018.
How should I report the results of studies in general?
Brooke BS, Ghaferi AA and Kibbe MR (2021) Effective Use of Reporting Guidelines to Improve the Quality of Surgical Research. JAMA surgery. DOI: 10.1001/jamasurg.2021.0519.
Dodson TB (2007) A guide for preparing a patient-oriented research manuscript. Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics 104(3): 307–315.
What are the minimum elements that a clinical study report should have?
Moher D, Hopewell S, Schulz KF, et al. (2010) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 340: c869.
Further readings
Introduction to Clinical Trials
A brief introduction to clinical trials
Issues in medical research
Van Calster B, Wynants L, Riley RD, et al. (2021) Methodology over metrics: Current scientific standards are a disservice to patients and society. Journal of clinical epidemiology. Elsevier. DOI: 10.1016/j.jclinepi.2021.05.018.
Pandis N, Fleming PS, Katsaros C, et al. (2021) Dental Research Waste in Design, Analysis, and Reporting: A Scoping Review. Journal of dental research 100(3): 245–252.
Chalmers I, Bracken MB, Djulbegovic B, et al. (2014) How to increase value and reduce waste when research priorities are set. The Lancet 383(9912): 156–165.
Regulatory framework
Ethics
Research Integrity Riga Stradins University link
The European Code of Conduct for Research Integrity Link
Why Are Gamers So Much Better Than Scientists at Catching Fraud? Link
Reproducibility crisis in scientific research. Link
Websites
Reporting checklists for medical researchers: https://www.goodreports.org/
Equator-Network: https://www.equator-network.org/
Recommended books
Schulz K and Grimes DA (2018) Essential Concepts in Clinical Research: Randomised Controlled Trials and Observational Epidemiology. 2nd ed. London, England: Elsevier Health Sciences. (articles available in The Lancet, but I suggest you get the print version.)
Moher D, Altman DG, Schulz K, Simera I, Wager E. (2014) Guidelines For Reporting Health Research A Users Manual. John Wiley and Sons Ltd. (this is a printed version of the main equator nertwork guides.)
Hulley SB, Cummings SR, Browner WS, et al. (2013) Designing Clinical Research. Wolters Kluwer/Lippincott Williams & Wilkins.
Kirkwood B and Sterne J (2003) Essential Medical Statistics. Wiley or Open Intro Statistics for Biomedical science (free)
Westreich D (2019) Epidemiology by Design: A Causal Approach to the Health Sciences. Oxford University Press.
Refresher Biostatistics, Epidemiology, and more Epidemiology
Cook, J.A., 2023. An Introduction to Clinical Trials. Oxford University Press.
Articles
Dworkin RH, Evans SR, Mbowe O, et al. (2021) Essential statistical principles of clinical trials of pain treatments. Pain reports 6(1): e863.
Assel M, Sjoberg D, Elders A, et al. (2019) Guidelines for reporting of statistics for clinical research in urology. BJU international 123(3): 401–410.
Templates and checklists for clinical research
Tools
Data entry: RedCap
Project and Data Management: Foldercase
Sample size calculator online / offline. How many patients?