Trials, Methodology Guides
Trial Methodology Guides
Plain-language primers on how to interpret peptide clinical-trial records, distinguish endpoint quality, and read a regulatory dossier without losing the thread.
- 10 min
How Clinical Trials Work for Peptide Therapeutics
Covers the full clinical trial pipeline for peptide therapeutics: preclinical work, IND filing, Phase 1 through Phase 4, surrogate versus hard endpoints, and how FDA and EMA authorisations differ from trial registration.
Read guide - 11 min
Phase 1 / 2 / 3 / 4 Trials Explained for Peptide Therapeutics
Detailed guide to Phase 0 through Phase 4 clinical trials as applied to peptide therapeutics. Covers microdosing, adaptive and basket designs, sample-size expectations per phase, and how to interpret primary endpoints, hazard ratios, and confidence intervals in Phase 3 result tables.
Read guide - 10 min
Primary vs Secondary vs Exploratory Endpoints
Explains the statistical and regulatory logic behind endpoint hierarchy in clinical trials, covering primary, key secondary, secondary, exploratory, and post-hoc outcomes. Details common endpoint types in peptide metabolic trials: HbA1c, percent body weight loss, MACE, patient-reported outcomes, and the hard-versus-surrogate distinction.
Read guide - 11 min
Bias, Blinding, and Why Double-Blind Phase III Matters
Covers the hierarchy of trial evidence, the main categories of bias (selection, measurement, recall, attrition, reporting), blinding methods including double-dummy, allocation concealment, intention-to-treat versus per-protocol analysis, and how to evaluate sponsor-funded trials.
Read guide - 9 min
How to Read a ClinicalTrials.gov Listing
Explains what ClinicalTrials.gov is, how its data fields map to the drug-development process, how to find peptide trials by intervention name, what study status categories mean, and how the registry record relates to eventual journal publication.
Read guide - 12 min
Endpoints in Metabolic Peptide Trials: HbA1c, MACE, Percent Body Weight
A detailed examination of the primary endpoints used in pivotal metabolic peptide trials: HbA1c reduction in T2DM, MACE in cardiovascular outcomes trials, percent body weight loss in obesity, and how time-to-event versus difference-in-means reporting methods are applied. Uses LEADER, SUSTAIN-6, SELECT, STEP-1, and SURPASS-2 as illustrative examples.
Read guide