Introduction to Clinical Research
Thu 16.30, BBCE Meeting Room, Institute of Stomatology, RSU
Thu 16.30, BBCE Meeting Room, 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.
Each Thursday, 16:30–17:30 EET, at the BBCE Meeting Room, Institute of Stomatology, RSU.
Clinical research requires handling specific concepts essential for the appropriate design, execution, analysis, and dissemination of results to ensure the security and benefit of patients.
This module provides the foundational concepts and terminology for understanding and designing clinical studies.
Each week, we will review one or two assigned papers. The main readings include works by Grimes and Schulz, available in the reading list below. A book with all the readings is also available.
Everyone is required to read the assigned papers and come prepared with notes.
At the beginning of each session, a presenter will be randomly selected to give a brief presentation (maximum 10 minutes) of the essential concepts from the week's paper.
Preparation: Print a copy of the assigned paper, read it thoroughly, and prepare notes.
Format: Use a blackboard and marker for the presentation. The use of PowerPoint or similar tools is not allowed. You may refer to your handwritten notes during the presentation.
Content: Present your understanding of the article, focusing on the essential concepts and identifying any unclear areas for group discussion. The goal is to prioritize comprehension over memorization.
Discussion: After the presentation, we will discuss any unclear or complex topics as a group. It is OK not to know or not to understand something; you are expected to identify what you understood and did not understand clearly. This will allow us to explain in more detail those aspects of each paper that need clarification.
A binder to organize printed copies of each paper, along with your handwritten notes.
A pen and a highlighter for annotating the papers.
To join, email me at sergio.uribe@rsu.lv.
A brief introduction to clinical trials
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.
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
Reporting checklists for medical researchers: https://www.goodreports.org/
Equator-Network: https://www.equator-network.org/ (and book 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.)
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.)
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.
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.
Data entry: RedCap
Project and Data Management: Foldercase
Sample size calculator online / offline. How many patients?