Scientific question & protocol
A protocol defines objectives, eligibility, interventions, outcomes, safety monitoring and the study plan.
KNOWLEDGE HUB / 03
Clinical research.
Explained.
A practical guide to how a medical question becomes study evidence—and why statisticians, programmers and scientific writers are central to every meaningful result.
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LEARN THESCIENCE OF EVIDENCE.
THE LIFECYCLE
From a question to an answer.
Clinical research tests scientific hypotheses under carefully designed procedures, safety oversight, informed consent and appropriate regulatory requirements.
Study design & statistical planning
Statisticians consider endpoints, sample size, bias, randomization, estimands and analyses before data collection.
Conduct & data collection
Sites collect data, monitor safety and follow the protocol. Data management supports completeness and integrity.
Analysis datasets & programming
Programmers prepare derived datasets, apply prespecified methods and produce traceable tables, figures and listings.
Interpretation & clinical study report
Study teams put numerical findings in clinical context, document limitations and prepare scientific reports.
Regulatory review & further learning
Appropriate authorities assess submissions for specific products and uses; the results inform subsequent development.
THE PEOPLE BEHIND THE NUMBERS
Who does what?
01
Biostatistician
Plans valid analytical approaches, quantifies uncertainty and interprets findings.
02
Statistical programmer
Implements analyses with reproducible code and verifies derived data and outputs.
03
Medical writer
Transforms protocols, analyses and findings into clear, coherent technical documents.
04
Study manager
Coordinates decisions, timelines, dependencies, stakeholders and quality checkpoints.
CLINICAL RESEARCH GLOSSARY
Speak the language of evidence.
Protocol+
The formal plan describing a clinical trial’s objectives, design, procedures, outcomes and oversight.
Endpoint+
A predefined measure used to evaluate an aspect of treatment effect, safety or another study question.
Randomization+
Assigning participants to groups by chance according to a prespecified process to reduce certain biases.
SAP+
A statistical analysis plan details statistical methods and decisions about how study data will be analyzed.
TFLs+
Tables, Figures and Listings; structured outputs used to display the results of clinical analyses.
CSR+
A clinical study report systematically documents study methods, conduct, results and interpretation.
CDISC+
A standards organization whose models can support structured clinical research data and regulatory submissions.
Phase II / III+
Development phases often involving different aims: dose and preliminary efficacy in Phase II, and larger confirmatory evaluation in Phase III. Designs vary.
CONTINUE LEARNING
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