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Clinical Studies

I. General comments regarding clinical research

Quality clinical research is essential for bringing the advances of basic research to the bedside and for achieving high‐level patient care. Clinical research also has many practical advantages for the thoughtful practicing care giver who would like to advance the field of medicine and his/her career. The conduct of clinical research and reporting of results demand the same rigor and attention to details as those required by basic research studies, although the analytical methods and study design differ.

For clinical investigators, especially those who are new to the field, an awareness of the principles and ethics of clinical research is essential. The following statement from the U.S. Food and Drug Administration is useful advice: “Adherence to the principles of good clinical practices, including adequate human subject protection is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted good clinical practice principles as laws and/or regulations.”
(https://www.fda.gov/scienceresearch/specialtopics/runningclinicaltrials/).


Clinical research is a branch of medical science that helps physicians identify the best and current recommendations for care of patients Clinical Practice vs. Clinical Research Examples of Clinical Research Advantages of Clinical Research vs basic “bench” research What is needed for conducting Clinical Research? Professional Advantages of Clinical Research

II. Various kinds of clinical research studies

Much of the following text has been taken from the AMA Manual of Style. A Guide for Authors and Editors. 10th Edition. Oxford University Press, pp 835-848. 1 The Manual of Style is an invaluable source that authors are strongly encouraged to consult as they plan and execute their clinical studies.

The following are some other useful resources on the various types of clinical research:

Before embarking on a clinic research study the investigator must understand the various kinds of studies that are available. Commonly used concepts and methods:

Case-Control studies Cohort studies
usually but not exclusively retrospective usually but not exclusively prospective
Outcome is measured before exposure Outcome is measured after exposure
Good for rare outcomes Best for common outcomes
Good for rare outcomes Expensive
Smaller numbers required Require large numbers
Quicker to complete Take a long time to complete
Prone to selection bias and recall bias Prone to attrition bias and the bias of change in methods over time
Inclusion and exclusion criteria must be listed for each The report of the study should include a description of the cohort and the length of follow-up, what independent variables were measured and how, and what outcomes were measured and how
Some common designs of RCTs: Some other types of studies:

References

1. AMA Manual of Style. A Guide for Authors and Editors. 10th Edition. Oxford University Press. http://www.amamanualofstyle.com/view/10.1093/jama/9780195176339.001.0001/med-9780195176339

2. DeAngelis CD, Drazen JM, Frizelle FA et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA.2004;292(11):1363-1364

3. Piaggio G, Elbourne DR, Altman DG, et al.; for the CONSORT group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006;295(10):1152-1160.

(Please retain the reference in reprint: http://www.letpub.com/index.php?page=author_education_clinical_studies)

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