Premier Insight 279: Executing A Dual-Submission Study

Dual submissions can pose a range of difficulties for clinical trials. While point-of-care (POC) tests offer significant convenience for patients and physicians, as well as cost savings for payers, achieving regulatory approval can be daunting. To achieve this, not only do sponsors have to show safety and efficacy, but they must also prove that a test is simple and poses an insignificant risk of an erroneous result. Assembling such proof requires thoughtful trial design and data collection.

In one case, a sponsor with a single-use, multiplexed, molecular, POC test was looking to qualitatively diagnose influenza A and B, by detecting viral RNA in nasal swabs from symptomatic patients. However, to be successful, they needed to obtain sufficient data to support a dual 510(k)/CLIA Waiver submission.

Gain insight into how the study’s multiple requirements were addressed to ensure that the data necessary to support both 510(k) clearance and CLIA waiver could be successfully collected within a single clinical trial.