JAMA sub-issue: "Responding to Challenges, Lasting Innovation" FDA officials talk about cancer research in pandemics.

During the pandemic, the FDA continued to work on cancer drug approval, and between March and May 2020, the Center of Excellence in Oncology (OCE) approved eight new molecular entities and 23 new oncology adaptations.
can we ensure data integrity and data quality while accelerating the development of oncology drugs? The severity of tumor diseases, the complexity of treatment options and the requirements of emergency care objectively require some unique considerations, which poses a greater challenge to oncology research during the COVID-19 pandemic.
this is a new view made by FDA officials on JAMA Oncology.
authors of the article include Dr. Anand Shah, DEPUTY Director of Medicine and Science at the FDA, Dr. Richard Pazdur, Director of the FDA Center of Excellence in Oncology (OCE), and Mr. Kushal T. Kadaka, a health care scientist in the Director's Office.
article said data integrity issues and "program deviations caused by pandemics" were issues of common concern to the bid and the FDA, which has been seeking as much flexibility as possible while protecting patient health and the integrity of clinical trials.
During the pandemic, telemedic services for patient monitoring have developed significantly, with telemedici methods that minimize exposure to disease to vulnerable subjects while continuing to collect data.
authors admit that for oncology studies, some late-stage patients may rely on trials to get drugs in study to treat related diseases, but not all endpoints are suitable for virtual evaluation.
also recommends that bidders seek advice from the FDA on how best to use medical imaging and blood tests when conducting clinical trials in areas where COVID-19 infections are active.
the future, there may be lessons from innovation in oncology research.
the FDA intends to review all interim policies issued during a pandemic to determine which regulatory flexibility should be permanently incorporated into the FDA's specific practices where appropriate," the authors said.
" flexibility is in many ways a natural extension of the work of regulators, which is already under way.
authors argue that the COVID-19 pandemic has generated data on how anti-tumor drugs are used outside of traditional clinical trial environments, and that responding to emergencies has forced a reassessment of endpoint assessments to accelerate patient-centered outcomes.
to shift some aspects of clinical trial operations to community settings, this acceleration can also be supported by reducing the burden on patients.
past, oncology clinical trials have been conducted using centers attached to major clinical trial sites, but there are concerns about certain GCP elements (Good Clinical Practices, Drug Clinical Trial Management Practice).
latest FDA guidance document released during the COVID-19 pandemic addresses how bidders should address these potential GCP issues and help ensure the integrity of clinical trials.
Issue VI Prescription Drug Manufacturers Payment Act (PDUFA VI), which clarifies the use of real-world evidence (RWE).
fda hopes to strengthen the use of real-world evidence (RWE) during PDUFA VII.
the FDA and the bid have seen digital platforms for patient registration and data collection.
authors say the use of digital registration platforms as part of the industry's help strategy is a powerful tool to help increase diversity in clinical trials.
the strategy and other innovative measures "at least represent a positive outcome of this challenging public health era."
: . . . Kushal T. Kadakia, Richard Pazdur, Anand Shah. U SFood and Drug Administration Support for Oncology Drug Development During COVID-19. Retrieved Oct 20, from the public number of WeChat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .