FREQUENTLY Asked Questions

How can a sponsor charge for its investigational drug in a blinded, controlled clinical trial without compromising the blind and the integrity of the clinical data generated from the trial?

View All FAQs
About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Regulatory Affairs Manager
Ellie has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process.

FDA recognizes that in certain situations, charging for an investigational drug in a clinical trial may have the potential to compromise the blinding of study subjects to which therapy they have received (e.g. in a situation in which subjects who are in the treatment arm of the study are charged, and subjects who are in the control arm are not charged). However, FDA believes that there are methods for preserving the blind study that sponsors could use in most cases. The method for preserving the blindness of the study will be unique to each study design.

When these situations arise, the sponsor may seek advice from the appropriate review division in the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) or from the review office in the Center for Biologics Evaluation and Research (CBER) on how to preserve the blind study, based on the specifics of the given situation.

Related Terms:
No items found.
Related FAQs:
More Questions? We're here to help!
SPEAK WITH A SPECIALIST