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Clinical Trial Design Course & Certification
Intermediate
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About
Pharmaceutical Medicine - 5. Clinical Trial Design training provides the knowledge and practical skills required to understand, plan, and evaluate clinical trial designs, ensuring that studies are scientifically sound, ethically conducted, statistically appropriate, and aligned with regulatory expectations. It equips learners with a strong foundation in clinical trial phases, study objectives, endpoint selection, control groups, randomisation, blinding, allocation methods, bias reduction, treatment comparisons, estimands, and practical design considerations used in pharmaceutical, biotechnology, and clinical research environments.
This Pharmaceutical Medicine - 5. Clinical Trial Design Course & Certification covers principles of clinical trial design, exploratory and confirmatory studies, Phase I-IV development, parallel-group and crossover designs, superiority, non-inferiority, and equivalence trials, randomisation and allocation concealment, blinding and masking, comparator selection, endpoint and outcome assessment, estimand considerations, adaptive and pragmatic designs, sample size and power considerations, interim analyses, protocol design, feasibility, and interpretation of clinical trial design decisions within regulatory and scientific frameworks. Upon successful completion, learners receive a certification demonstrating their understanding of clinical trial design principles and their application in pharmaceutical medicine, clinical development, biostatistics, and regulatory-compliant research planning.
Who Should Enrol?
- Clinical Trial Physicians and Pharmaceutical Medicine Professionals
- Clinical Researchers and Clinical Investigators
- Biostatisticians and Statistical Programmers
- Clinical Research Associates (CRAs) and Clinical Research Professionals
- Clinical Data Managers and Clinical Data Analysts
- Medical Affairs and Clinical Development Professionals
- Pharmaceutical, Biotechnology, and CRO Personnel
- Regulatory Affairs and Quality Assurance Professionals involved in clinical research
- Students, Graduates, and Professionals seeking a career in Pharmaceutical Medicine, Clinical Research, and Drug Development
What you will learn
Understand the principles of clinical trial design, study objectives, endpoint selection, randomisation, blinding, control groups, and treatment allocation in pharmaceutical medicine and clinical research.
Learn how to design and evaluate Phase I–IV clinical trials while balancing scientific validity, ethical considerations, feasibility, patient safety, and regulatory expectations.
Develop knowledge of parallel-group, crossover, superiority, non-inferiority, and equivalence study designs, comparator selection, allocation concealment, bias reduction, endpoint assessment, estimands, adaptive designs, interim analyses, and protocol development.
Gain understanding of how sample size, statistical power, study populations, and operational considerations influence trial design, and apply best practices for developing robust, efficient, ethical, and regulatory-compliant clinical trials.
Course Syllabus
- What clinical trial design is as a science - the WHY behind a trial's structure
- Why it is distinct from operational, protocol-writing and execution content
- The design decision chain - question, control, design family, endpoint, sample size
- Meet Northwind Therapeutics and veltarib's two contrasting trials (superiority vs placebo; non-inferiority vs active)
- The seven-module roadmap and how the course is assessed
- Applied, minimal-maths scope; cross-references to Endpoints, Sample Size Calculations and SAPs
- Scope and boundary - conceptual design literacy, not a substitute for a trial statistician
- Randomisation - why it works and how (simple, permuted-block, stratified, minimisation)
- Allocation concealment versus blinding
- Blinding and masking - single, double, triple, open-label and double-dummy
- Control groups - placebo, active and historical (ICH E10)
- The estimand and the comparison mindset (ICH E9(R1))
- Worked example - choosing and justifying the design for veltarib's superiority trial
- Parallel designs - different people in different arms
- Crossover designs - each patient as their own control (AB/BA)
- Within-subject versus between-subject comparison and efficiency
- Washout, carryover, and period and sequence effects
- When crossover fits and when it does not
- Worked example - deciding parallel versus crossover for two veltarib questions
- What 'adaptive' means - pre-planned changes using accumulating data
- Interim analyses, multiplicity and alpha spending
- Group-sequential designs and O'Brien-Fleming-style boundaries (conceptually)
- Sample-size re-estimation and response-adaptive randomisation
- Seamless Phase 2/3 and the role of the data monitoring committee
- Worked example - reading veltarib's Phase 2 adaptive schema and its safeguards
- The question each design answers
- The non-inferiority margin - what it means and how it is justified
- One-sided logic and reading a confidence interval against the margin
- Assay sensitivity and the constancy assumption
- Intention-to-treat versus per-protocol in non-inferiority; biocreep
- Worked example - reading veltarib's non-inferiority result against the 0.3% margin
- When a randomised control is impractical or unethical
- Single-arm trials and external/historical controls - and their pitfalls
- Master protocols - basket, umbrella and platform designs
- Biomarker-defined populations in precision oncology
- Efficiency and the caveats of master protocols
- Worked example - choosing single-arm, basket or umbrella for an onvatinib setting
- Bias versus random error
- Selection, performance, detection, attrition and reporting bias
- The design defence matched to each bias
- Confounding and regression to the mean
- How design defends against bias in layers
- Worked example - spot the bias in a flawed veltarib design and prescribe the fix
- How the design choice drives the endpoint and the sample size
- Superiority, non-inferiority, crossover, adaptive and single-arm - the sizing implications, conceptually
- The estimand as the connective tissue
- See next - Endpoints in Clinical Trials
- See next - Sample Size Calculations and Statistical Analysis Plans
- Worked example - tracing veltarib's superiority trial from design to endpoint to N
- Synthesis - the design decision chain from question to sample size
- The core elements, the design families and the comparison types
- Bias defends in layers - five biases, five defences
- A one-page 'choosing a trial design' checklist
- Where the standards live and how this connects to the next courses
- Boundary note - conceptual literacy; the protocol, SAP and guidance govern
- 📘 Bonus: Clinical Trial Design eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development points on completion of this course.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (estimands and sensitivity analysis), ICH E3 (clinical study reports) and CONSORT 2010 reporting standards for time-to-event endpoints, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by practitioners in oncology and clinical-trial biostatistics to ensure that learners can read a Kaplan-Meier curve and a forest plot, interpret a hazard ratio, and report a survival analysis that will withstand regulatory and peer review.
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