Manisha Desai | The Importance of Data Integrity in COVID-19 Clinical Trials

<p>Manisha Desai is a professor of medicine (research) and of biomedical data science, and director of the Quantitative Sciences Unit at Stanford University. She is an expert in the design and analysis of clinical trials and epidemiologic studies across multiple diseases, including COVID-19. In this podcast, she provides some insights into the challenges and progress of COVID-19 clinical trials.</p><p>When COVID happened, Manisha knew her team’s expertise in clinical trials would allow them to get up to speed quickly to study this new disease. So, she augmented her team with additional data science experts to focus on trials to identify safe and effective drugs to help prevent hospitalization and disease progression.“This whole period has been so anxiety-inducing for so many of us, it's actually been nice to focus that energy and anxiety towards work that could be part of the solution to some of the crisis,” she says. In studies so far, they have learned that there's a real disparity in outcomes by ethnicity and race and they are trying to determine if that’s due to genetic, cultural, or environmental factors. They are also launching trials to figure out questions about immunity, seroprevalence and incidents. </p><p>Clinical trials are the gold standard for identifying safe and effective therapies. Since these trials require a lot of time and rigor, the findings have high internal validity. In a typical clinical trial, there is a sequential plan which starts by designing the study, setting up a data and safety monitoring board, database capture, and analysis plan. It's a totally different in a pandemic when you want to launch all of these events quickly, so developing the analysis plan and designing the study don't happen sequentially. “You're talking to the FDA and the IRB at the same time that you're developing the protocol, just as the ideas are sort of coming together. Everyone needs the study launched, we're all sheltering in place and solutions need to be found, so everyone is rushing to do this,” she says.