Clinical trials
sciencedirect.com shows its articles on its own site.
Read the article on sciencedirect.com ↗Article · Dec 2018 · 1 min read
In brief
In brief
This article provides a comprehensive overview of clinical trial design and implementation in pediatric surgery. It covers trial classification, essential design components including study population selection and outcome definition, and critical considerations for validity and generalizability of results.
Written by the GCMD Library team from the article.
Publication date: Available online 24 October 2018
Source: Seminars in Pediatric Surgery
Author(s): Peter C. Minneci, Katherine J. Deans
Abstract
Clinical trials can be used to generate data on safety, efficacy, and/or effectiveness of treatments. They can be classified based on their purpose, phase, or design. Key components of clinical trial design include: identifying the study question and population; clearly defining the treatment and comparison groups; choosing the method of treatment group allocation; defining the primary and secondary outcomes; performing a power analysis; outlining an analytic plan; and reporting results. Critical issues to consider when either designing a trial or interpreting the results of a trial include evaluating the validity and generalizability of the results and assessing the appropriateness of the control group. Designing and implementing clinical trials in pediatric surgery is challenging, but well-constructed and executed trials are instrumental in improving clinical care.