Article | October 27, 2020

Drug Development For Rare Disease And Oncology During The COVID-19 Pandemic

By Amy McKee, Vice President Regulatory Consulting Services, Parexel

Cancer patient

“Cancer did not pause with the rest of the country.” This poignant observation from Kristen Seamans, a patient representative for the rare-cancer advocacy group Sarah’s Cure, seems to capture the challenges facing patients, clinicians, drug developers and regulators alike during this unprecedented crisis.

Indeed, how has the pandemic affected patients in the search for treatments for rare disease and cancer? How have clinical trials and regulatory activities been impacted? What have we learned about trial conduct, patient recruitment, risk mitigation and the pace of regulatory approvals? How are patients coping? This article outlines some of the findings from a recent virtual discussion with Parexel experts and representatives from the patient advocacy group, Sara’s Cure.

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