--- title: "ITT / PP, Intent-to-Treat vs Per-Protocol | MedTech Terms" description: "Two analysis populations: ITT analyzes everyone randomized; PP analyzes only those compliant with protocol. Plain-English Clinical & Trials definition for MedTe" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/itt-pp#term", "name": "Intent-to-Treat vs Per-Protocol", "alternateName": "ITT / PP", "description": "ITT preserves randomization and is the primary analysis for superiority trials. 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It provides a more conservative estimate of treatment effect in superiority trials, reflecting real-world effectiveness." } }, { "@type": "Question", "name": "When is Per-Protocol (PP) analysis typically preferred as the primary analysis?", "acceptedAnswer": { "@type": "Answer", "text": "Per-Protocol analysis is typically preferred as the primary analysis in non-inferiority trials. This is because ITT analysis in non-inferiority trials may dilute the true treatment effect, potentially leading to an erroneous conclusion of non-inferiority when there is a meaningful difference." } }, { "@type": "Question", "name": "Why is it important to compare ITT and PP results in MedTech clinical trials?", "acceptedAnswer": { "@type": "Answer", "text": "Comparing ITT and PP results is crucial for a comprehensive understanding of treatment effects and to assess the robustness of the trial findings. Significant discrepancies between these analyses can indicate issues such as differential dropout rates or non-adherence, which regulators will scrutinize." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Intent-to-Treat vs Per-Protocol [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)ITT / PP # Intent-to-Treat vs Per-Protocol Two analysis populations: ITT analyzes everyone randomized; PP analyzes only those compliant with protocol. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ITT preserves randomization and is the primary analysis for superiority trials. Per-Protocol analyses are typically supportive - and primary in non-inferiority trials, where ITT can bias toward 'no difference'. What the regulation says The FDA and other regulatory bodies emphasize the importance of both Intent-to-Treat (ITT) and Per-Protocol (PP) analyses in clinical trials, particularly for MedTech devices. Regulators typically expect ITT to be the primary analysis for superiority trials to maintain the benefits of randomization. For non-inferiority trials, PP analysis is often considered primary, as ITT can sometimes obscure important treatment differences and bias towards a finding of non-inferiority, as outlined in FDA guidance documents on non-inferiority clinical trials. ## What this means in practice Non-inferiority device trials require pre-specified analysis populations and consistent ITT/PP results; mismatch is a frequent reason for FDA panel debate. ## Examples - A superiority trial for a new cardiac stent uses ITT analysis as the primary endpoint to assess whether the new stent is statistically significantly better than an existing one, including all randomized patients regardless of whether they received the assigned stent. - A non-inferiority trial for a diagnostic imaging device primarily uses PP analysis to demonstrate that the new device is not clinically worse than the current standard, focusing on patients who completed the study according to protocol. - During an FDA review of an orthopedic implant trial, a significant divergence between ITT and PP results prompts the agency to request further justification from the manufacturer regarding patient adherence and dropout rates. Common pitfalls - • Misinterpreting an ITT analysis that shows no significant difference as a definitive lack of treatment effect, when a PP analysis might reveal otherwise. - • Failing to pre-specify the analysis populations for both ITT and PP analyses in the clinical trial protocol. - • Not adequately addressing discrepancies between ITT and PP results in regulatory submissions, leading to questions or objections from regulatory bodies. - • Applying ITT analysis as the primary endpoint in a non-inferiority trial without careful consideration of its potential to bias the results toward equivalence. - • Excluding participants from the ITT analysis who dropped out or did not adhere to the protocol, thereby compromising the integrity of randomization. ## Frequently asked questions What is the primary advantage of Intent-to-Treat (ITT) analysis? The primary advantage of ITT analysis is that it preserves the integrity of randomization, preventing bias that can arise from participant dropout or non-adherence. It provides a more conservative estimate of treatment effect in superiority trials, reflecting real-world effectiveness. When is Per-Protocol (PP) analysis typically preferred as the primary analysis? Why is it important to compare ITT and PP results in MedTech clinical trials? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Lost to Follow-up Subjects whose outcome data are missing because they did not complete planned visits. ](/terms/lost-to-followup)[ Clinical & Trials Pivotal Trial Definitive clinical study designed to establish safety and effectiveness for marketing authorization. ](/terms/pivotal-trial) ### More in Clinical & Trials · Same category [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event)[ Clinical & Trials ALCOA+ Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available). ](/terms/alcoa-plus)[ Clinical & Trials Analytical Sensitivity An IVD's ability to detect small quantities of an analyte. ](/terms/analytical-sensitivity) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ICH· 2 NIH· 1 1. [1 ICH E9 Verified ICH · ich.org ](https://www.ich.org/) 2. [2 ClinicalTrials.gov Verified NIH · clinicaltrials.gov ](https://clinicaltrials.gov/) 3. [3 ICH Guidelines Verified ICH · ich.org ](https://www.ich.org/page/ich-guidelines) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Acronym ITT / PP Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=itt-pp) Learn in 60 seconds Card Lesson Quiz Two analysis populations: ITT analyzes everyone randomized; PP analyzes only those compliant with protocol. - · Non-inferiority device trials require pre-specified analysis populations and consistent ITT/PP results; mismatch is a frequent reason for FDA panel debate. - · Per-Protocol analyses are typically supportive - and primary in non-inferiority trials, where ITT can bias toward 'no difference'. Remember this Watch out: Misinterpreting an ITT analysis that shows no significant difference as a definitive lack of treatment effect, when a PP analysis might reveal otherwise. Related terms - [Pivotal Trial ](/terms/pivotal-trial) - [Lost to Follow-up ](/terms/lost-to-followup) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Blinding and Masking ](/terms/blinding) - [Master Protocol (Basket / Umbrella / Platform) ](/terms/master-protocol) - [Sample Size and Statistical Power ](/terms/sample-size-power) - [Bayesian Trial Design ](/terms/bayesian-trial) - [Electronic Data Capture(EDC) ](/terms/edc) - [ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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