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What the data on this site means: trial phases, endpoints, FDA milestones and the numbers that matter for a clinical-stage company. Every explanation lists its sources.

• Accelerated approvalAccelerated approval is an FDA pathway that allows faster approval of drugs for serious conditions that fill…
• Biologics License Application (BLA)A Biologics License Application (BLA) is the route through which biologics are licensed in the United States…
• BiosimilarA biosimilar is a biologic medication that is highly similar to a biologic medication already approved by…
• Breakthrough therapy designationBreakthrough therapy designation is a United States Food and Drug Administration designation that expedites…
• Complete response letterA Complete Response Letter is a regulatory action by the US Food and Drug Administration in response to a…
• Confidence intervalA confidence interval is a pair of lower and upper bounds likely to contain, in repeated sampling, the true…
• Double-blind studyA double-blind study is an experiment in which two parties are blinded to some information, most often both…
• EMA marketing authorisationAn EMA centralised marketing authorisation is an authorisation granted by the European Commission, obtained…
• Fast track designationFast track designation is a designation that a drug company must request from the FDA, which decides whether…
• Investigational New Drug (IND)Investigational New Drug (IND) is the US Food and Drug Administration programme through which a…
• New Drug Application (NDA)A New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally…
• Orphan drug designationOrphan drug designation is the status given to a drug intended for a rare disease or condition, with the…
• P-valueA p-value is the probability of obtaining test results at least as extreme as the result actually observed,…
• Phase 1 trialA Phase I trial is the first stage of testing in human subjects . These trials are designed to test the…
• Phase 2 trialA Phase 2 trial is a stage of human testing designed to assess how well a drug works, while continuing the…
• Phase 3 trialA Phase III trial is a randomized controlled multicentre trial on a large group of patients . It is designed…
• Phase 4 (post-marketing)Phase IV is a postmarketing surveillance trial, also known as a drug monitoring trial, which aims to assure…
• Primary completion datePrimary completion date is the date that the final subject was examined or received an intervention for the…
• Priority reviewPriority review is a designation granted by the United States Food and Drug Administration (FDA) to certain…
• Randomized controlled trialA randomized controlled trial (RCT) is a type of statistical experiment designed to evaluate the efficacy or…
• Share dilutionShare dilution is the decrease in existing shareholders' ownership percentage of a company as a result of…