Clinical Research: Phase 1 - Phase 4

PM360: How COVID Has Reshaped the Clinical Trial Regulatory Landscape

The concept of patient centricity is hardly new, but in recent months it has assumed new urgency as industry and regulators have had to adapt to an evolving landscape. The evolution is spurring substantial changes in how clinical trials are developed and implemented, as regulators revise their processes and issue updated guidance documents to encourage speed and efficiency while still ensuring patient safety.

The U.S. Food and Drug Administration (FDA) has been at the forefront of recent changes, notably through its issuance of Emergency Use Authorizations (EUAs) to facilitate the availability of testing kits, treatments, and vaccines; the establishment of its Coronavirus Treatment Acceleration Program; and the authorization of reference panel comparative data to enhance diagnostic capabilities. Over the past year and a half, the FDA has also issued 13 guidance documents, some of which have been updated to address various aspects of product development and clinical trials, reflecting a renewed focus on the patient journey in the wake of the pandemic.

Read more at PM360