Safeguarding Patients Through Science: Global Patient Safety
Our commitment to the safety of our patients is at the heart of our mission to expand the highest-quality therapies to more people around the world. We uphold that commitment by continuously monitoring, analyzing, and communicating the benefits and risks of current and emerging treatments.
Giving Patients a Voice
The safety of every patient is important to us. Through our robust global safety infrastructure, we actively encourage patients to share their experiences, including reporting any adverse events they may experience. By reporting concerns, patients play a critical role in helping us evaluate potential side effects and take action to protect others.
We work closely with healthcare providers whose observations and expertise are essential in ensuring effective communication of adverse events and medication safety with patients. By fostering this partnership, we create a system where both patients and providers contribute to the safe and effective use of our medicines from their first use in clinical trials to their prescribed use.
“BeOne Medicines prioritizes patients’ well-being from development to the very last patient taking one of our medicines. Our Global Patient Safety (GPS) team strives to ensure the safer use of medicines throughout the product lifecycle through continuous data collection and generation of safety insights.”
Han Ma, M.D., Ph.D.
Chief Safety Officer and SVP, Global Patient Safety
Reporting Adverse Events
We all share the responsibility to report adverse events observed with our products so that they may be investigated, actioned, and communicated accordingly.
To report an adverse event or side effect, please talk to your healthcare provider and contact us here.
Minimizing Risk to Patients Through Ongoing Safety Evaluation
All medicines are evaluated to ensure the medicine’s benefits outweigh the possible risks. Benefits are commonly expressed as the proven therapeutic good of medicine and include efficacy, convenience, and life effects. Risk is the probability of harm being caused and includes product tolerability and potential side effects. A positive benefit-risk balance is based on the correct prescriber, product, patient, timing, dosage, and use in a real-world setting.
The Global Patient Safety team continuously evaluates emerging safety data that may arise from various data sources, including clinical and non-clinical. The data are analyzed for potentially causal associations between an active substance or medicinal product and risks to patients. Understanding these “safety signals” helps us monitor patients’ experience with our medications and potential changes to their safety profile.
Identified risks are managed through a Risk Management Plan (RMP), which represents a company’s position on the risk management strategy for a product, including:
- the medicine’s safety profile,
- how its risks will be prevented or minimized in patients,
- plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine,
- measuring the effectiveness of risk-minimization measures.
Helping Patients and Healthcare Providers Make Informed Decisions
We understand how important good information about medicines is to the health and well-being of our patients. That’s why we continuously generate insights through pharmacovigilance and patient safety activities across the product lifecycle to improve information about our medicines’ benefits and risks.
Important patient safety data is collected through a global safety network, such as adverse event reporting, or through targeted scientific research, such as epidemiological studies. Our team of scientists and physicians analyzes this data to develop the best understanding of a medicine’s safety.
Any new information is communicated to patients, healthcare providers (HCP), and health authorities through organized channels.
Documents describing known safety risks are developed and maintained throughout a product’s development in clinical trials and use in real-world settings. These documents are known as “labels” and contain information about adverse events observed, including their seriousness, description of their nature, and frequency of occurrence.
Labeling documents are the basis of safe and effective prescribing, as they are regulated, public guidance documents that draw on diverse data and medical expertise to inform on a product’s benefit/risk.
Safety in Clinical Trials
Through dedicated clinically focused teams, BeOne’s Global Patient Safety works closely with our partners and clinical investigators to ensure comprehensive safety measures are taken to protect the well-being of participants enrolled in a research study. Our team of scientists, physicians, and safety professionals ensures that potential risks are minimized while maximizing the study’s benefits through:
- safety input into study and protocol design
- keeping patients informed about potential risks and benefits through informed consent
- rigorous monitoring of adverse events from clinical trials
- assessment of signals for our products utilizing all available clinical and epidemiological data
- robust safety monitoring and governance to ensure proactive and timely communication with clinical trial sites and participants.
To learn more, visit our Clinical Trials page where you can find out if you’re eligible to participate. Please consult with your doctor to discuss if a clinical trial is right for you.