While the FDA strictly enforces the handling of investigational drugs, the COVID-19 pandemic is shining a spotlight on the accountability issues involved. Agency regulations are only two paragraphs long, giving investigators and sponsors little guidance on the specifics of the drug management process. In the absence of clear instruction from the FDA and other regulators, the clinical trials industry has begun to develop its own standards. Read More

The upheaval in trials caused by the COVID-19 pandemic should result in an increased number of options for trial participants, greater support for increasingly complex trial protocol designs and more collaboration among sponsors. Read More

As the medical community shifts much of its focus — and its resources — to battling the ongoing COVID-19 pandemic, clinical trial sponsors and sites are left wondering what to do about ongoing drug and device studies unrelated to the coronavirus. Which studies should be paused and which should be allowed to continue? Could modifications to study protocols around data collection and patient visits strike a balance between maintaining both patient safety and the integrity of ongoing trials? Read More

Continuing clinical trials in the face of the COVID-19 pandemic has posed myriad challenges to an industry some experts have characterized as largely unprepared for a public health emergency. But lessons learned from operating under pandemic conditions may accelerate innovations the industry currently is only toying with, including decentralization of clinical trials and technology-aided remote monitoring. Read More