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Clinical Trial & Research Methodology

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Abstractions about designing and evaluating empirical and clinical research — trial designs (community-based clinical trials, single-arm studies, stepped-wedge trials), statistical estimators and diagnostics (fixed-effects estimator, relative risk reduction, Youden's J statistic), and considerations shaping study validity (clinical data management, self-licensing, scientific consensus).

20 abstractions in this family — domain-specific abstractions that sit near one another in structural-signature space (k-means over structural-signature embeddings). Each is shown with its short description.

  • Clinical data management — Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.
  • Combinatorial Meta-Analysis — Combinatorial meta-analysis (CMA) is the study of the behaviour of statistical properties of combinations of studies from a meta-analytic dataset (typically in social science research).
  • Community-based clinical trial — Community-based clinical trials are clinical trials conducted directly through doctors and clinics rather than academic research facilities.
  • Conditionality principle — The most well-known conditionality principle is the principle of statistical inference that Allan Birnbaum formally defined and studied in an article in the Journal of the American Statistical Association, .
  • Eadie–Hofstee diagram — In biochemistry, an Eadie–Hofstee plot (or Eadie–Hofstee diagram) is a graphical representation of the Michaelis–Menten equation in enzyme kinetics.
  • Field Experiment — Field experiments are experiments carried out outside of laboratory settings.
  • Fixed-Effects Estimator — In panel data analysis the term fixed effects estimator (also known as the within estimator) is used to refer to an estimator for the coefficients in the regression model including those fixed effects (one time-invariant intercept for each subject).
  • In silico clinical trials — Accurate computer models of a treatment and its deployment, as well as patient characteristics, are necessary precursors for the development of in silico clinical trials.The European Medicines Agency (EMA) and the U.S.
  • Modifiable temporal unit problem — In addition, the Modifiable Temporal Unit Problem can also arise when the time units are irregular or when the data is missing for some periods.
  • Parameter space — The parameter space is the space of all possible parameter values that define a particular mathematical model.
  • Phi Coefficient — The signed Pearson correlation of two varying binary variables, computed from the normalized cross-product difference of their 2×2 table.
  • Relational data mining — Relational data mining discovers patterns spanning multiple related tables, entities, or relations rather than restricting analysis to attributes in one flat table.
  • Relative risk reduction — In epidemiology, the relative risk reduction (RRR) or efficacy is the relative decrease in the risk of an adverse event in the exposed group compared to an unexposed group.
  • Scientific consensus — Scientific consensus is the collective judgment, position, and opinion of the vast majority of active, qualified experts on a conclusion in a specific scientific discipline.
  • Self-licensing — Self-licensing (also moral self-licensing, moral licensing, or licensing effect) is a term used in social psychology and marketing to describe the subconscious phenomenon whereby increased confidence and security in one's self-image or self-concept tends to make that individual worry less about the consequences of subsequent immoral behavior and, therefore, more likely to make immoral choices and act immorally.
  • Single-arm study design — A single-arm study design is a type of clinical or experimental study where all participants receive the same intervention, with no control or placebo group.
  • Stepped-Wedge Trial — In medicine, a stepped-wedge trial (or SWT) is a type of randomised controlled trial (RCT).
  • Survival Analysis — Survival analysis is a branch of statistics for analyzing the expected duration of time until one event occurs, such as death in biological organisms and failure in mechanical systems.
  • Tensiomyography — Tensiomyography (TMG) is a measuring method for detection of skeletal muscles' contractile properties.
  • Youden's J Statistic — Youden's J statistic (also called Youden's index) is a single statistic that captures the performance of a dichotomous diagnostic test.