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?

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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.

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About the Author
Proxima CRO Team
Ellie Reynolds
Quality Assurance

Ellie Reynolds is from Dallas, Texas and is a Quality Assurance and Regulatory Affairs Associate for Proxima. She just completed her M.B.E. in Bioengineering at Rice University and previously received her B.E. in Biomedical Engineering from Vanderbilt University. Prior to completing her master's degree, she worked in strategy consulting for biotech and pharma companies and is eager to combine her educational background and professional experience in this role.  

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