Generally speaking, the FDA wants to see all data collected during drug development – all clinical trials, across all indications, using any formulation of your drug, in any region of the world. They may not look at every piece of data submitted but, in our experience, reviewers prefer to have access to all data, giving them the flexibility to dig into any part of any study during their review. 

Of course, there are exceptions. We’ve seen data lost from a warehouse fire in a server room, data corrupted by a foreign-orchestrated cyber attack, and data that mysteriously disappeared during transfer of information after companies merged. Those are the more extreme cases, but it is not uncommon for data to be lost over time. The FDA is generally accepting of such scenarios, assuming the missing studies are not critical to efficacy in the indication of interest. 

For products that have been on the market for an extended period of time or are available over-the-counter, another common issue is trials run by another company. While the data is readily available, the submitting sponsor may have no proprietary right to this data, and therefore cannot rely on it or submit it with their application. 

The final reason we frequently see data not submitted is when a study was conducted outside the US, sometimes with study files that are not in English. This can be controversial because the FDA will often ask for this data to be translated and submitted, but it may depend on where the study was conducted. Many countries around the world have health authorities with similar regulations to those in the US, and a population with demographics similar to the US, making the data both reliable and generalizable to the US. However, data collected in countries that don’t fit those criteria may not be viewed as useful to the agency’s review, and they may not care to see that data at all. 

Regardless of your unique circumstances, we always recommend that sponsors discuss the specifics of the clinical data to be submitted to the agency during their pre-submission meeting, at the latest. Contact us to speak with one of our Biometrics Regulatory Experts if you have questions about your data submission. 

Evan Zucker, Principal Biostatistician, has 8 years of experience providing statistical support for clinical trials, with a specific focus on late-stage regulatory submissions. Mr. Zucker has supported upwards of twenty marketing applications and over a dozen FDA meetings, often working as the primary author of integrated statistical analysis plans and CDISC-compliant integrated analysis dataset (ADaM) specifications for the ISS and ISE. In supporting marketing application submissions, he also acts as a data standards expert, reviewing and updating study data packages to ensure compliance with the latest FDA requirements, technical rejection criteria, and CDISC/legacy guidelines. Mr. Zucker has collaborated with clinical researchers and medical authors across various therapeutic areas, including pain/anesthesia, psychiatry, otolaryngology, oncology, ophthalmology, rare/genetic diseases, and vaccines/infectious diseases.