Drug-Diagnostic Sponsors Must Educate Sites to Avoid Bias That Can Kill Approval Chances

Sponsors of new drugs seeking approval with a companion in vitro diagnostic (IVD) need to work with trial sites to ensure they are not prescreening patients by local test methods — a process that can prove fatal for regulatory approval, an expert says. Instead, the diagnostic platform intended for commercialization with the new drug should be used in the pivotal studies.
Drug Industry Daily