Access to Investigational Medicines
Patient access to investigational medicines
Investigational medicines are treatments that have not yet been approved by regulatory agencies. Patients can receive them by joining a clinical trial or, in exceptional cases, when a doctor requests single‑patient access on their behalf.
What are clinical trials?
- Clinical trials are research studies that test new medicines or treatments to determine safety and effectiveness.
- They run in phases and help develop new medicines for patients who need them.
- Participation is voluntary and is designed to protect patient safety and rights.
How patients can access investigational medicines
1. Join a clinical trial
- Patients may receive investigational medicines as part of a Bayer‑sponsored research study.
- Trials have specific eligibility criteria and study procedures; talk to your doctor to learn whether a suitable trial exists.
2. Single‑patient access (compassionate use)
- Patients may receive investigational medicines as part of a Bayer‑sponsored research study.
- In rare cases where no approved treatments are available or effective, a doctor can request access to an investigational medicine for a patient with a severe or life‑threatening condition.
- These requests are carefully reviewed to ensure safety and legal compliance.
- Doctors must make the request; patients cannot apply directly.
What to expect
- Decisions prioritize patient safety and confidentiality.
- Each request or trial participation follows strict review and oversight procedures.
- Bayer responds to physician requests and maintains patient privacy throughout the process.
Find a trial
- Use the Bayer Clinical Trials Finder to search for recruiting trials by condition, view study details, and learn about participation criteria.
- If you’re interested, speak with your doctor to review eligibility and next steps.
Key takeaways
- Investigational medicines = not yet approved.
- Two access routes: clinical trials or doctor‑requested single‑patient access.
- Doctors must request single‑patient access; patients cannot apply directly.
- For trial searches and details, use the Bayer Clinical Trials Finder
FAQ
Q: What is an investigational medicine?
A: A medicine that has not yet been approved by regulatory authorities for general use.
Q: How can my loved one access an investigational medicine?
A: By joining a clinical trial or, in rare cases, through a doctor’s single‑patient request when approved treatments aren’t available.
Q: Can I apply directly for single‑patient access?
A: No - a treating doctor must submit the request.
Q: Where can I find Bayer clinical trials?
A: Search the Bayer Clinical Trials Finder at https://clinicaltrials.bayer.com/.
Q: Will my privacy be protected?
A: Yes - requests and trial participation follow confidentiality and safety procedures.