Topic: Medical Devices

Differences Between Drug and Medical Device Trials: CSRs

While drugs and medical devices are both essential in modern medical care, there are times when standard clinical development processes seem to treat medical devices as an afterthought. For example, medical writers for a CRO conducting studies of both drugs and devices must learn to interpret a drug-centric guidance document to author an appropriate Clinical… Read more »

Settling on a Framework for LDT Regulation: Update

Update: The FDA post-election statement on delaying implementation of the agency’s draft guidance on LDTs affirms the status quo – for now. The delay allays the concerns of some stakeholders about potential effects of greater FDA involvement in LDT regulation, such as slowing innovation in diagnostics and patient access to the most advanced diagnostics and,… Read more »

Why Diagnostics Development Is Different

All clinical trials share core requirements such as the need to exclude bias and provide evidence of effectiveness. However, diagnostics trials differ from drug trials in many important ways. As a result, diagnostics development requires substantial differences in planning, trial design and trial execution. It will come as no surprise to diagnostics professionals that diagnostics… Read more »