This online series of training videos provides introductory educational materials for learners who are new to clinical research and collaboration. The goal is to give learners a general understanding of clinical research and data analysis to facilitate communication and collaboration with a quantitative expert, such as a biostatistician.
In-person/virtual specialized workshops using these prerequisite modules can be designed for a group of clinical and translational learners. These workshops dive deeper into the topics presented and use real and applicable examples specific to the workshop audience. Please contact BERDCore@duke.edu for more information.
Introduction to Research and Design
The first video in our module introduces the general life cycle of clinical research. By the end of the video, learners will know the important characteristics that every research study should have, namely integrity, transparency, and reproducibility.
Formulating the Research Question
This video details how a scientific research question is developed. We also introduce the primary outcome of a research study, an important characteristic that has great impact on the entire study, including the study’s design, the number of individuals enrolled, and conclusions that can be drawn when the study ends.
The Null and Alternative Hypotheses
In this video, we discuss how to convert the scientific research question into a testable hypothesis, and explore the null and alternative components of a statistical hypothesis.
Study Design and Data Collection
This video broadly introduces study design and data collection. We discuss the two main types of research studies, how many individuals are needed for a research study, collecting raw data, and producing analysis datasets.
Previous recordings created by collaborative biostatisticians that may be helpful for clinical and translational learners are listed below.
These use a journal article case study to illustrate concepts in clinical research.
Scientific Process I: Formulating the Question
This module introduces the first three steps of the scientific process: observing a phenomenon or pattern, formulating the scientific question, and developing the hypothesis.
Scientific Process II: Analysis and Inference
This module discusses sampling from a population of interest and the p-value – a quantity that permeates research but has limitations.
Scientific Process III: Design and Descriptive Analysis
This module describes power and sample size calculation for designing a study and common summary measures and graphical displays for exploring data.
The Statistical Analysis Plan
The Statistical Analysis Plan (SAP) is an important document that serves as a roadmap for the entire research project. This module highlights some of the key pieces of information needed in a SAP.
Survival Analysis I: Kaplan-Meier Estimator and Log Rank Test
Survival analyses are used when a researcher is interested in the amount of time it takes for some event to occur. This first model introduces this type of outcome and a key method of estimating the chance of being event-free over time.
Survival Analysis II: The Cox Proportional Hazard Model
Survival analyses are used when a researcher is interested in the amount of time it takes for some event to occur. This second module covers the most common modeling technique used in survival analyses.
The Biostats4you website was developed to serve medical and public health researchers and professionals who wish to learn more about biostatistics. The site contains carefully selected and reviewed training materials especially suited for a non-statistician audience.
This site is being developed and maintained by members of the Biostatistics, Epidemiology and Research Design Special Interest Group (BERD SIG) of the Association for Clinical and Translational Science (ACTS).
Duke University School of Medicine's Clinical Research Training Program (CRTP) provides Duke and National Institutes of Health (NIH) physicians, investigators and other healthcare professionals with the academic training needed to stand out in today's dynamic clinical research environment.
The Clinical Research Training Program promotes leading-edge investigative practices grounded in sound scientific principles. As one of the oldest programs of it's kind, the program has offered highly relevant courses and mentored research that impact quantitative and methodological knowledge to conceptualize and carry our hypothesis driven multidisciplinary research for over 30 years.