Introductory Clinical Research

Wed at 3pm, lecture room on 1st floor Institute of Stomatology, RSU

Good clinical research requires four elements: 

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

Websites

Recommended books

Articles

Templates and checklists for clinical research



Document repository

Summary