BeOne Clinical Trial Transparency

BeOne commitment to data disclosure and transparency

BeOne is a global oncology company dedicated to delivering innovative medicines affordably around the world. We believe that clinical trial transparency and sharing of our clinical trial data support biomedical innovation, increase broader awareness in clinical research, and improve public trust in our products and treatments.

Clinical trial transparency

We are committed to responsible sharing of our clinical trial data and follow the Biotechnology Industry Association (BIO) Principles on Clinical Trial Data Sharing to help advance clinical research. To this end, BeOne registers phase 1 to 4 interventional trials and applicable non-interventional studies on publicly accessible websites in accordance with regional and national regulatory and policy requirements worldwide. In support of transparency and bringing patients worldwide potential treatment options, we share a global list of BeOne studies currently recruiting on our corporate website: https://beonemedicines.com/science/clinical-trials. This website features a list of BeOne studies that are currently recruiting within the United States.

For completed studies, we disclose results of phase 1 to 4 interventional trials and applicable non-interventional studies on accessible websites in compliance with regulatory timelines and policy expectations. In the United States, information about our clinical trials and results from completed trials can be found on clinicaltrials.gov. For select studies, we publish Study Protocols, Statistical Analysis Plans, Clinical Study Reports/Summaries, and Plain Language Summaries of the study’s design, objectives, and results written in clear language that is understandable to people without medical training. Further demonstrating BeOne’s commitment to research transparency, we submit clinical trial results for publication in scientific journals or otherwise make available the results of all clinical trials, including results of significant medical importance, regardless of outcome.

Data sharing

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. For investigational medicines whose product development has been discontinued, BeOne provides access to data after key study results have been published.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with relevant expertise conducting novel scientific research may submit a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data. We list global BeOne studies currently available for data sharing on our website: https://beonemedicines.com/science/clinical-trials