Presubmission and Clinical Submission Data Collection

A central issue in data collection is how to identify relevant, high-quality data that are readily available for appropriate decision making and to do so in a cost-effective, timely manner, within realistic, projected managed timelines. What is high-quality data? High-quality data refers to data that can be used without further revisions or data that will produce conclusions and interpretations that would be derived from error-free data, data that are accurate, reliable and ready for use. The key to producing such high-quality data is to engineer data quality into the entire preclinical, clinical trial, presubmission and clinical submission process, early in the program.

The factors critical to the successful retrieval and collection of high-quality data begins far upstream from the clinical trial or the start of your FDA Briefing Document and/or halfway through Clinical Phase 3 on your way to clinical submission. High-quality procedures affect all stages of preclinical, clinical trial, presubmission and clinical submission data.

Lets begin with the clinical protocol. The protocol should have:

• clear, specific objectives
• objectives that must be in a testable hypothesis form and design
• well-defined target population with specific criteria
• specific criteria for inclusion and exclusion of study subjects
• a study design that is relatively simple, because complexity introduces error
• relevant, achievable endpoints, primary and secondary
• a detailed schedule of activities and observations
• a process and standard of operation that address steps taken to assure and ensure high-quality data.

High-quality data provides FDA with scientifically valid data, statistically significant, clinically meaningful, data with confidence and credible endpoints and objectives, ready for review and decision. The return on investment when assuring and ensuring high-quality data is immediate and immeasurable.