Universitat Internacional de Catalunya - BarcelonaDesign of Clinical Studies and Clinical Trials
Main language of instruction: English
Other languages of instruction: Catalan, Spanish
Head instructor
Dra. María José MARTÍNEZ - mjmartinez@uic.es
Office hours
Students are requested to email to arrange a meeting.
Dr María José MARTÍNEZ - mjmartinez@uic.es
Clinical practice questions arising in relation to the prevention, diagnosis and treatment of patients require the development of clinical studies to be handled appropriately. Moreover, stakeholders need to know which the best and most cost-effective preventive, diagnostic or treatment strategies are to apply to the population. For this reason, different designs of epidemiological studies have been developed depending on the primary research question. Broadly classified into experimental and observational, even within these two groups, there are specific designs.
The increasing volume of available scientific information needs the development of new forms of scientific literature to summarize the information available. In recent years, there have been many articles with meta-analysis reviews that summarize the evidence about the benefits and risks of the various interventions and treatments based on the available primary studies. These include the systematic reviews by the Cochrane Collaboration.
Systematic reviews, unlike narrative reviews, constitute per se a research model (called secondary research) that, starting from a well-defined therapeutic clinical question, establishes and applies systematic methods designed to search, identify, select, describe and analyze information from relevant primary studies, from which some useful conclusions for clinical practice and for future research can be reached.
This course presents the basis for the design, implementation, and critical interpretation of primary clinical studies and systematic reviews with meta-analysis on the effects of health interventions.
None.
The course consists of a first part on design of primary clinical trials and a second part on systematic reviews (secondary research).
Chapter 1 Introduction
1.1 Research question
1.2 Types of clinical trials: Observational versusexperimental
Chapter 2 Design of an observational clinical trial
Chapter 3 Critical assessment of an observational trial
Chapter 4 Design of an experimental clinical trial
Chapter 5 Critical assessment of an experimental clinical trial
Chapter 6 Introduction to the systematic reviews
Chapter 7 Development of a systematic review
Chapter 8 Data management in a systematic review
Chapter 9 Critical assessment of an article of a primary trial or a systematic review
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Grimes DA, Schulz KF. Bias and causal associations in observational research. Lancet 2002; 359: 248–52
Grimes DA, Schulz KF. Cohort studies: marching towards outcomes. Lancet 2002; 359: 341–45
Grimes DA, Schulz KF. Descriptive studies: what they can and cannot do. Lancet 2002; 359: 145–49.
ICYMI: “Ask the wrong question and find the wrong answer.” Great blog on Simpson's Paradox http://bit.ly/1S1qU8z
Koletsi D, Pandis N, Fleming PS. Sample size in orthodontic randomized controlled trials: are numbers justified? European Journal of Orthodontics 36 (2014) 67–73.
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Sackett DL. Choosing the best research design for each question. BMJ 1997; 315: 1636.
Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet 2002; 359: 614–18.
Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet 2002; 359: 696–700.
Schulz KF, Grimes DA. Case-control studies: research in reverse. Lancet 2002: 359: 431–34
Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet 2002; 359: 515–19.
Schulz KF, Grimes DA. Multiplicity in randomised trials II: subgroup and interim analyses. Lancet 2005; 365: 1657–61.
Schulz KF, Grimes DA. Sample size calculations in randomised trials: mandatory and mystical. Lancet 2005; 365: 1348–53.
Schulz KF, Grimes DA. Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet 2002; 359: 781–85.
World Medical Association. Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects. JAMA 2013; 310 (20): 2191-4.
EQUATOR: http://www.equator-network.org/
What is Cochrane Collaboration (video 7 MINUTES): https://www.youtube.com/watch?v=AhtchOL1ofc
Producing Cochrane reviews (video 9 MINUTES): https://www.youtube.com/watch?v=IGMiVGfWRH0&ebc=ANyPxKqaXs0suna0y82-2SltCIEHJsZLrb721e5kJH7TdAONSTiCNqi_S9NB-DmOcFXZk1xOTqMQTjCexxux3GP58o3CYJLiqg&nohtml5=False
An introduction to The Cochrane Collaboration (60 MINUTES): https://www.youtube.com/watch?v=balnyrVol_g&nohtml5=False
RevMan Installation: http://tech.cochrane.org/revman/download
Cochrane systematic review handbook: http://www.cochrane.org/handbook
Critical appraisal of studies: http://www.casp-uk.net/#!casp-tools-checklists/c18f8
Clinical trial concept (2 minutes): https://vimeo.com/69347194
Good science and bad science (14 minutes): https://www.youtube.com/watch?v=HB5SLYQwG_8
Reasons to not stop trials early (4 minutes): https://www.youtube.com/watch?v=vbk54Y9DPZQ