Study Design
Premier Insight 279: Executing a Dual-Submission Study
Background Point-of-care (POC) tests offer significant convenience for patients and physicians, as well as cost-savings for payers. Yet, achieving regulatory approval can be daunting. Sponsors not only have to show safety and efficacy, they have to prove that the test is simple and poses an insignificant risk of an erroneous result. Assembling such proof requires...