The ability to conduct research with human subjects is a privilege that Sanofi takes very seriously and comes with obligations to the patients and their families. Sanofi recognizes that some patients who have participated in clinical trials may have benefited individually from the investigational product. We also recognize that once an individual’s participation in a trial has ended, they may not have immediate access to the investigational product.
Depending on the patient’s medical need, including the availability of alternative therapies and an assessment of what is known about the benefits and risks of the investigational product, Sanofi will consider providing our clinical trial patients with access post-trial.
The following conditions should be met in order for a patient to be considered for post- trial access:
- The patient has been part of a trial in which the investigational product was Administered.
- The request for post-trial access comes via the trial investigator.
- The patient specifically consents to the post-trial access program that is proposed, including the criteria about re-evaluation of benefit-risk.
- The administration of the investigational product resulted in clinical benefit to the patient, based on the investigator’s benefit/risk assessment of the patient’s response to the intervention and what is known about the investigational product at the time of the decision (in consultation with Sanofi).
- The patient has a serious or life-threatening condition.
- The patient does not qualify for any ongoing Sanofi clinical trials for the same disease or condition.
- The treating physician and/or investigator has determined that post-trial access is the best medical option for the patient.
- The investigational product is not approved/authorized or not available by other means in the country where the trial was conducted.
Post-trial Access is requested by and under the responsibility of the Investigator/Physician.
How To Make a Request?
If you are participating in a clinical trial with Sanofi as an investigator and would like to obtain additional information on the availability, have any inquires and/or would like to make a request for PTA; please contact your local Sanofi clinical or medical team in your country.
If you are participating in a clinical trial with Sanofi as a patient and interested or would like more information about Post-trial Access, you may contact your Treating Physician/Investigator.