Clinical Research: Phase 1 - Phase 4

Pharmaceutical Outsourcing: Reimagining the Patient Experience in an Evolving Clinical Trial Regulatory Landscape

“Patient centricity” has long been a guiding principle of clinical trial design and conduct, and it has become even more critical in the COVID era as trial sponsors and regulatory authorities have had to adapt to a continually shifting landscape. Pandemic-related restrictions have prompted substantial changes in how clinical trials are developed and implemented, requiring sponsors to comply with new guidance and processes designed to promote speed and efficiency while remaining mindful of patient safety.

The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations to facilitate the availability of testing kits, treatments, and vaccines; established a Coronavirus Treatment Acceleration Program; and authorized use of reference panel comparative data to enhance diagnostic capabilities. Additionally, the FDA has issued thirteen guidance documents since May 2020, including several updates designed to address various aspects of product development and clinical trials (Table 1). The FDA’s recent actions reflect a renewed focus on the patient experience as the pandemic has forced a reimagining of standard practices and protocols.

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