The COVID-19 pandemic has forced clinical research to make bold changes to survive. Pharma Initiatives’ Mark Shapiro joined ArcheMedX to discuss what changes are temporary – and what will be true disruption.
On May 14, the FDA issued an update to its guidance on conducting clinical trials for medical products during the COVID-19 and ongoing public health emergency. Here’s what you need to know now.
There are many ways a clinical trial can go wrong: There might be delays in site identification, initiation, or patient enrollment. There could be high initial screen failure rates or improperly enrolled subjects. Procedural errors like those related to randomization, dosing, or clinical test implementation might occur.
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