Universitat Internacional de Catalunya
Design of Clinical Studies and Clinical Trials
Other languages of instruction: Catalan, Spanish
Teaching staff
Introduction
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.
Pre-course requirements
None.
Objectives
- Differentiate types of study design
- Choose the proper study design according to the research question
- Critically read an article from a primary study
- Distinguish between different types of review
- Understand the practical utility of reviews
- Understand the steps for developing a systematic review protocol
- Critically read a review article
- Know how to interpret a meta-analysis
Competences/Learning outcomes of the degree programme
- CB10 - Acquire learning skills that allow them to continue studying in a self-directed and autonomous mode.
- CB6 - Knowledge and understanding to provide a basis or opportunity for originality in developing and / or applying ideas in a research context.
- CB7 - To apply the acquired knowledge, and develop their ability to solve problems in new environments within broader (or multidisciplinary) contexts related to their field of study.
- CB8 - Integrate knowledge and deals with the complexity of formulate judgments based on scientific evidence, from information that may be incomplete or limited, include reflecting on social and ethical responsibilities linked to the application of their knowledge and judgments.
- CG1 - Ability to integrate new knowledge through research and study, and deal with complexity
- CG2 - Ability to review analysis and discussion of the experimental results and to issue the corresponding conclusions.
- CG3 - Self learning ability in the development of new techniques, in the knowledge of new scientific concepts and in the search of new scientific information
- CG4 - Ability to argue and defend own scientific ideas and listen, analyze, evaluate and respond to the ideas of another person.
- CT1 - Ability to work in multidisciplinary and multicultural groups
Learning outcomes of the subject
- A global and critical view of the different types of design of clinical research studies applied to dentistry is acquired.
- Learning is acquired to distinguish systematic reviews that are of better quality and more reliable from those that are not.
- Knowledge is acquired about the methodology of systematic reviews
- Learning is acquired to interpret the results of a systematic review
Syllabus
The course consists of a first part on design of primary clinical trials and a second part on systematic reviews (secondary research).
- Research question
- Types of clinical trials: Observational versusexperimental
Teaching and learning activities
Online
Teaching activities: TRB, CM, MC
Learning activities: CT (0.5 ECTS) PRO (0.5 ECTS)
Evaluation systems and criteria
Online
Continuous evaluation - EC (10%)
Case study work - RC (40%)
Final exam - PFE (50%)
Bibliography and resources
Ferreira González I, Urrútia G, Alonso-Coello P. Revisiones sistemáticas y metaanálisis: bases conceptuales e interpretación. Rev Esp Cardiol. 2011;64(8):688–696.
Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet 2002; 359: 57-61
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.
Levin KA. Study design IV. Cohort studies. Evidence-Based Dentistry (2003) 7, 51-52.
Pandis N, Walsh T, Polychronopoulou A, Katsaros Ch, Eliades T. Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials. European Journal of Orthodontics 35 (2013) 783–789.
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