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Introduction
CHAPTER 11 Clinical Research in
Dermatologic Surgery
Abigail Waldman Molly Storer Maryam M. Asgari
SUMMARY
The central tenet of clinical research is answering a concrete, researchable
question that addresses an uncertainty that the investigator wants to resolve.
Clinical research is a broad, umbrella term that encompasses many types of
scientific investigation including clinical trials as well as epidemiologic, behavioral, outcomes, or health services research.
Many of the high-quality surgical techniques and improvements in clinical care
enjoyed by dermatologic surgeons today result from clinical research physicianโscientists.
Beginner Tips
The foundation of any clinical research project is a clinically significant and impactful
research question.
A thorough review of the literature surrounding the clinical research hypothesis is
necessary to establish the context of the work and to give it meaning.
A systematic method for organizing and archiving the literature search is essential.
Expert Tips
Understanding basic statistical concepts and tools can help reduce bias from potential
confounding variables and improve the understanding of the application of clinical findings.
Prior to initiating a study, a power analysis should be performed in order to determine
the minimal number of data points required to reveal a significant result.
Additional preparation for undertaking clinical research in dermatologic surgery
includes refining skills in areas such as study design and biostatistics.
The p-value is a measure of the likelihood that the result could be seen by chance.
Overall, a p-value <0.05, or less than 5%, is considered the threshold for being statistically significant; however, the lower the p-value, the more likely the result is to be true.
Donโt Forget!
Clinical trials that have one or more sites in the United States or that test a drug or
device that is manufactured in the United States or its territories must be registered with ClinicalTrials.Gov.
In some cases, rigorous inclusion and exclusion criteria may select for ideal patients
that fail to reflect a general population. Thus, the results of the study may not have generalizability.
Pitfalls and Cautions
Confounding occurs when there is a factor that is related to the independent and
dependent variables and thus affects the outcomes of the study.
Bias is any error in the study design, orchestration or analysis that results in an error of
inference.
Early involvement with a statistician is recommended for those without formal
epidemiologic training.
The most interesting and novel of findings will not have any clinical impact if they are
not disseminated and ultimately published.
CHAPTER 11 Clinical Research in