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  • Preclinical & Laboratory Foundations Learning Path
  • Phase I – First-in-Human Trials Learning Path
  • Phase II & III – Efficacy & Pivotal Trials Learning Path
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval

About

Clinical Research Statistics provides a practical foundation for understanding, interpreting, and communicating statistical evidence in clinical research. The course covers key statistical concepts including data types, populations and samples, descriptive statistics, probability, sampling, variability, study design, randomisation, bias, confounding, hypothesis testing, confidence intervals, p-values, effect measures, and interpretation of clinical trial and observational study findings.
This Clinical Research Statistics Training Course provides comprehensive knowledge of how statistical methods are applied throughout clinical research, from summarising patient data and assessing study populations to interpreting treatment effects, statistical significance, precision, and clinical relevance. The course also addresses practical interpretation of common statistical outputs, including confidence intervals, odds ratios, hazard ratios, mean differences, correlation coefficients, subgroup analyses, endpoint hierarchies, and sources of random and systematic error. Participants will develop the ability to critically evaluate clinical research results, identify common statistical and methodological pitfalls, and communicate evidence-based conclusions clearly and appropriately.

Who Should Enrol?

  • Clinical Research Professionals and Clinical Research Associates
  • Clinical Data Management and Biostatistics Professionals
  • Medical Affairs and Clinical Development Teams
  • Pharmacovigilance and Drug Safety Professionals
  • Healthcare and Life Sciences Professionals involved in clinical research
  • Quality Assurance and Regulatory Affairs Professionals
  • Researchers, Investigators, and Academic Professionals
  • Anyone responsible for interpreting or communicating clinical research data and statistical results
📢 Every purchase also includes our FREE companion Statistics for Clinical Research eBook, designed to help you apply principles in real-world inspection readiness settings.

What you will learn

Understand the fundamental principles of clinical research statistics, including data types, populations and samples, descriptive statistics, measures of central tendency and variability, and appropriate methods for summarising clinical data.

Learn how statistical methods support clinical study design, including randomisation, sampling, bias, confounding, probability, hypothesis testing, confidence intervals, p-values, and statistical significance.

Develop practical knowledge of effect measures and statistical interpretation, including mean differences, risk measures, odds ratios, hazard ratios, correlation, confidence intervals, and the distinction between statistical and clinical significance.

Gain practical skills in critically interpreting clinical trial and observational study results, assessing precision and uncertainty, recognising common sources of bias and error, evaluating subgroup and endpoint findings, and communicating evidence-based statistical conclusions.

Course Syllabus

  1. Why statistical thinking matters when reading trials
  2. Population versus sample
  3. Parameter versus statistic
  4. Estimation and sampling error
  5. Variable types - nominal, ordinal, discrete, continuous
  6. Levels of measurement - nominal, ordinal, interval, ratio
  7. From data to evidence
  8. Random versus systematic error (bias)
  9. HELIOS-2 - population and sample in practice

  1. Measures of centre - mean, median, mode
  2. Measures of spread - range, IQR, variance, SD
  3. The normal distribution and the empirical rule (68-95-99.7)
  4. Shape - skew and outliers
  5. Mean versus median for skewed data
  6. Reading histograms
  7. Reading box plots
  8. Spotting misleading graphs
  9. HELIOS-2 - reading a table of centres

  1. Sampling variability and the sampling distribution
  2. Standard error versus standard deviation
  3. Point versus interval estimates
  4. Interpreting a 95% confidence interval correctly
  5. What makes a confidence interval wide or narrow
  6. Confidence intervals versus p-values
  7. CIs for differences (crossing 0) and ratios (crossing 1)
  8. HELIOS-2 - reading a hazard ratio and its interval

  1. Null and alternative hypotheses
  2. Significance level (alpha) and the decision rule
  3. The p-value defined - and what it is not
  4. Common p-value misinterpretations
  5. Type I and Type II errors
  6. Power and sample-size intuition
  7. One-sided versus two-sided tests
  8. Which statistical test? - a reader's map
  9. Statistical versus clinical significance

  1. Experimental versus observational studies
  2. Anatomy of a randomised controlled trial
  3. Randomisation, allocation concealment and blinding
  4. RCT variants - parallel, crossover, factorial
  5. Cohort, case-control and cross-sectional designs
  6. The hierarchy of evidence
  7. Matching design to question
  8. HELIOS-2 - dissecting the design

  1. Selection bias
  2. Information and measurement bias
  3. Recall and attrition bias
  4. Confounding - and how RCTs versus observational studies handle it
  5. Effect modification versus confounding
  6. Direction of non-differential misclassification
  7. Internal versus external validity
  8. HELIOS-2 - reading the dropout and appraising claims

  1. Association, causation and the correlation coefficient
  2. Simple and multiple linear regression
  3. Adjusted mean differences and covariates
  4. Logistic regression and odds ratios
  5. Time-to-event analysis - Kaplan-Meier and hazard ratios
  6. Censoring and the proportional-hazards check
  7. Relative versus absolute effects
  8. HELIOS-2 - a worked regression read-through

  1. Primary, secondary and exploratory endpoints
  2. Effect size versus the p-value
  3. Analysis populations - ITT versus per-protocol
  4. Missing data and how it is handled
  5. Multiplicity and alpha spending
  6. Subgroups, superiority and non-inferiority
  7. Reading Table 1, the CONSORT diagram and forest plots
  8. HELIOS-2 - a full worked read-through and verdict
  9. Red-flags checklist

  1. The critical-reader mindset
  2. A one-page interpretation checklist
  3. The whole HELIOS-2 read, in one view
  4. Communicating results to non-specialists
  5. Course boundary and disclaimer

  1. 📘 Bonus: Statistics for Clinical Research eBook (Free with purchase)

Course Benefits

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Free eBook

Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever

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CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

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Certification

Receive a personal certificate to show your subject knowledge on course completion.

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Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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Keep Up to Date

You will stay up to date with the statistical-reporting expectations of ICH E9 and E9(R1), the CONSORT and STROBE reporting guidelines, and evolving good practice in trial interpretation, as our training courses are constantly monitored, reviewed and updated.

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Learn from Industry Experts

The course content has been developed by clinical-trial statisticians and experienced trial readers to ensure that non-statisticians can interpret trial results correctly at their desks. Every module is example-led around the fictional HELIOS-2 trial and follows the same rhythm - concept, worked example and knowledge check - so learning transfers directly to the reports you read.


Our Certified Customers

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