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CLINICAL RESEARCH

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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 physician–scientists.

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  • 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.

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  • 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.

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  • 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.

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  • 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.

INTRODUCTION

Clinical research is defined as patient-oriented investigation conducted with human subjects aimed at advancing medical knowledge to benefit human health.1 It 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. The central tenet of clinical research is answering a concrete, researchable question that addresses an uncertainty that the investigator wants to resolve. Dermatologic surgeons are ...

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