Our Transparency Policy
Our Data Disclosure and Clinical Transparency Policy
Arcus Biosciences is committed to improving human health through the development of innovative therapies. We strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing our clinical trial data can help to advance such research, while reinforcing public confidence in the safety and efficacy of our medicines.
If you have a specific inquiry regarding Arcus Biosciences’ Data Disclosure and Transparency commitment or practices, please contact us at [email protected].
We adhere to the Data Sharing Principles set by the industry codes and by the International Committee of Medical Journal Editors (ICMJE).
We certify that we have established policies and procedures to implement data-sharing principles. Our data transparency policy can be publicly reviewed on this website.
1. Complying with International Standards
Our transparency policy is aligned on a global level by taking into consideration practices and principles from each country in which we operate.
2. Registering Clinical Trials
Arcus Biosciences acknowledges the importance of the ICMJE recommendations and registers all interventional studies (Phases 1-4) with Clinicaltrials.gov prior to the first patient being registered for the study. We are also committed to complying with all applicable clinical trial registration requirements worldwide.
3. Providing Results Summaries
Arcus Biosciences is committed to disclosing results summaries on Clinicaltrials.gov and/or other worldwide registries. It will be made available, at the latest, within 30 days after both EU and US approval of the new medicine or the new indication.
4. Providing Lay Summaries
Arcus Biosciences is committed to writing a report in lay terms to ensure that the study participants and the public can have access to our results summaries in plain language. We are also committed to translating the lay summary to the official languages of the countries in which the study took place.
5. Providing Clinical Reports
Arcus Biosciences is committed to disclosing clinical reports supporting the marketing authorization in Europe or Canada. The clinical reports will be disclosed on a public website.
6. Publishing Clinical Trials in Scientific Literature
Arcus Biosciences is committed to submitting for publication in scientific literature or through other means (i.e., on a company-sponsored website, at an appropriate scientific conference, etc.), the results of all company-sponsored Phase 3 clinical trials and clinical trials of significant medical importance regardless of whether their outcomes are positive or negative.
7. Sharing of Clinical Trial Data with Qualified Scientific Researchers
Arcus Biosciences is committed to sharing clinical trial data with external qualified scientific researchers in the interest of advancing public health.
Clinical Trial Data includes protocol data, statistical analysis plans, individual patient dataset, and clinical study reports. We redact or anonymize personal data to protect patient privacy. Arcus Biosciences' commitment to sharing of clinical trial data applies to clinical trials in patients for medicines and indications approved in the US and the EU.
Arcus Biosciences discloses its data sharing plan on this website and on Clinicaltrials.gov.
Data Sharing Request
Arcus Biosciences is committed to sharing clinical trial data with external qualified scientific researchers in the interest of advancing public health.
Who can make a request?Which studies are within the scope of the Arcus Biosciences Data Sharing policy?What types of data are available?When can the request be made?How can a request be made?How is the request assessed by Arcus Biosciences?What happens if your request is approved?Data Sharing Agreement
Qualified scientific researchers may request clinical trial data from Arcus Biosciences.