Clinical Trials
Every decision we make about our clinical trials begins and ends with how we can best serve patients’ needs. Through rigorous training, auditing, and a steadfast commitment to transparency and access, we hold ourselves to the highest standards — because the patients who trust us deserve nothing less.
Advancing new medicines
We design and conduct clinical trials to evaluate the safety and efficacy of our medicines, and we do so with a deep commitment to delivering high-quality, reliable clinical data while minimizing the burden for clinical trial participants.
Our cross-functional teams design and execute clinical trials using a Clinical Study Risk Management framework — a systematic, proactive approach to identifying, assessing, and mitigating risk while driving continuous improvement at every stage. Every employee and external partner is held to the highest compliance and safety standards, as defined by our Code of Business Conduct and Ethics and our Clinical Trial Policy.
Before any trial begins, an independent Institutional Review Board or Ethics Committee reviews and approves our protocols, as required by health authorities worldwide. Across every region where we operate, we comply with local regulations and align with ethical standards:
- International Council for Harmonization (ICH)
- Declaration of Helsinki
- Belmont Report
Board of directors
Our Board of Directors receive quarterly updates on relevant clinical trial status and business performance.
Executive committee
Our CMO, a member of the Executive Committee, provides oversight of clinical trials.
Clinical trial senior leadership
Insmed’s Vice President of Clinical Development Operations and CMO hold monthly Clinical Project Reviews and receive written biweekly updates from cross-functional clinical study teams.
Raising the bar on training and oversight
The patients who enroll in our clinical trials place their trust in us — and that trust demands we hold ourselves, and everyone involved, to the highest standards of training, oversight, and accountability. All investigative site staff, trial operations teams, and contract research organization (CROs) are trained on Good Clinical Practice (ICH-GCP). Our Quality Assurance team regularly audits CROs and vendors for regulatory compliance and our Development Operations team conducts independent oversight monitoring visits to protect the integrity of our data. Our cross-functional Vendor Oversight Committee drives transparency and consistency across all vendor relationships, and periodic internal audits of our clinical trial development systems ensure we continuously raise the bar — because patients are counting on us to get it right.
Making trial information easily accessible
We’re committed to sharing clear, digestible information about our clinical trials with the public, and we do so in compliance with applicable global and local laws and regulations. Our trials are registered and our results disclosed on public clinical trial registries in the United States, Europe, and Japan. To help patients and researchers learn about our trials, we post links to these registries — as well as summaries of results when available — on our website. We also make patient-friendly “plain language summaries” of our clinical trial data available to the public so patients can easily understand the outcomes.
As part of our overarching goal of making effective treatments accessible to appropriate patients, we aim to enroll patients in our clinical trials who reflect the potential patient population for a given therapy. We do so by creating a geographic footprint of the potential patient population using best available scientific data, while continuously refining our trial designs to reduce participant burden.
We regularly evaluate evolving health authority guidance around trial transparency and access to further enhance our practices.
Learn more about our current clinical trials
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