Investigational medicines - what are they?
An investigational medicine is one that has not yet been approved for use by regulatory agencies such as the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
You - or someone you’re caring for - may be able to be treated by your doctor with an investigational medicine in certain circumstances when other drugs are not available or did not work. You may be able to access an investigational medicine either by participating in a clinical trial or, in exceptional cases, through single patient access (sometimes referred to as “compassionate use”). Please check your local regulations to see if single patient access is possible in your country.
Investigational medicines are strictly controlled to ensure utmost safety for patients. We have to evaluate all patients against detailed criteria so we can’t promise that you will receive an investigational medicine if your doctor requests it for you. We can, however, promise to review your doctor’s application with great care and to let them know the results of our assessment as quickly as possible.
Accessing an investigational medicine
Patients can access an investigational medicine by joining a clinical trial. Clinical trials are research studies that are designed to determine if a medicine is safe and effective for patients.
You can find out about Bayer’s clinical trials from our TrialFinder website. There are a range of local trial registries that you can visit to learn more about what is available in your country. You can also check www.clinicaltrials.gov for a worldwide database of public and privately funded clinical trials.
If you think there is a trial that is suitable for you, or someone you’re caring for, the first step is to talk to your doctor. Patients can’t apply directly and there are clear scientific criteria for who can participate in a trial, therefore you should discuss with your doctor whether a clinical trial could be right for you.
Single patient access
If your doctor believes that an investigational medicine could help you but you cannot take part in a clinical trial, it might still be possible to access the treatment. Single patient access may not be allowed in some countries, so please check your local regulations to find out. This is only possible in exceptional circumstances when you, or someone you’re caring for, are suffering from a severely debilitating or life-threatening disease that cannot be treated with available approved drugs, or where all possible approved treatments have been unsuccessful. At this point, your doctor might consider an investigational treatment as the only way to help.
Your doctor must request access to the investigational medicine on your behalf. We’ve provided details below so your doctor can contact us directly.
Replies on single patient access
We know how important it is to receive a fast response. Your safety and wellbeing, however, is our first priority. Therefore, we need time to consider your doctor’s request with the greatest of care.
We will let your doctor know we have received the application within two working days. Once we have all the information we need, we will do our best to complete our assessment and get back to your doctor within five working days.
As we review the application, we will respect patient confidentiality. We comply with national privacy laws and will not share details outside of the decision-making team without your permission.
We can only agree to provide an investigational medicine to your doctor if we agree with their medical evaluation that the possible benefits of the drug outweigh the potential risks. We take care to ensure that we comply with the laws that apply in different countries for investigational medicines and treatments. We also work together with doctors to ensure that they comply with local laws regarding access to investigational medicines, including monitoring and recording patient safety information. We consider every request for access carefully, but we cannot guarantee that it will be granted.
Information for doctors and healthcare providers
If you’re a treating doctor and would like to request access to investigational medicines for your patient, please contact the Bayer medical information team in your country. You will find further contact details here.
Alternatively you can email trialinfo.MIS@bayer.com or, if you are located in the United States, you can call +1-888-842-2937.