By Christina Tay, Safety Officer on Oct 18, 2017 9:00:00 AM
Good quality clinical trial study data that comes through the FDA could potentially avoid delay in data extraction, review and verification that will help drive your product to market faster. In order to do all these tasks quickly and consistently, the submission of your study data needs to be standardized to help the FDA streamline the review process and enable consistent use of analysis tools throughout all clinical trials. Time and time again, we see inconsistencies and irregularities in documentation of study data.
Here are some of the more common pitfalls that we see when submitting study data
- Site ID variability or was not included
- Dataset submitted did not include standardized data variables
- Protocol deviations submitted as pdf listings and not in a searchable format
- Subjects were not listed using standardized ID variables
- Definition files were not user friendly and the definition of dataset variables were not available
- Critical endpoint data (rows of data) are missing that were possibly due to inadequate data validation by sponsor
The long way is the short way
The normal review process for clinical trial data can take up to 60 days (Figure 1). So, if the data is not standardized, it’s very difficult to go through all the data in this length of time. One group within the FDA, the Bioresearch Monitoring Branch, emphasizes the need for standardization and suggests that the best way to ensure you submit good quality data to the FDA is to have advance discussions with your sponsor and the FDA on your study data standardization plan (SDSP). Make sure to discuss topics that include information about e-source data collection and/or data extraction from electronic data capture (EDC) systems, data integration, the process of pre-license and pre-approval data verification inspections, and Good Clinical Practice (GCP) tips. Investing in the time and resources to develop a solid clinical trial data standardization plan will allow the review process go smoothly and bring your new drug to the market faster and help those who need it most.
Here are some additional references
- The FDA has numerous references on clinical trial standardization best practices but probably the most concise is the FDA Study Data Standards fact sheet.
- For more information on standardization tips please listen to the 20-minute webinar of Dr. Bhanu Kanna of the FDA Center for Biologics Evaluation and Research.
Do you have any additional references to share for best practices of clinical trial data standardization? Please comment below.