Oncology research mid-pandemic: Challenges may bring durable innovation
Though clinical research, in general, has been challenged during the COVID-19 pandemic, oncology trials “have several unique considerations due to disease severity, regimen complexity, and acute care requirements” that have caused even greater challenges, US FDA officials wrote in a new viewpoint published in JAMA Oncology.
Data integrity issues and “pandemic-induced protocol deviations” are a concern for sponsors and FDA alike, and the agency has been attempting to be as flexible as is possible while safeguarding patient wellbeing and clinical trial integrity, according to Anand Shah, FDA deputy commissioner for medical and scientific affairs, Richard Pazdur, director of the FDA Oncology Center of Excellence (OCE), and Kushal Kadaka, health scientist in the office of the commissioner. Telehealth for patient monitoring has burgeoned during the pandemic, for example, an approach that minimizes disease exposure for vulnerable trial participants while allowing data collection to continue.
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