FDA clinical trial protection failures, and an AI that can beat curling’s top players
Science Magazine Podcast
Science Podcast
4.3 • 842 Ratings
🗓️ 1 October 2020
⏱️ 31 minutes
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| 0:00.0 | This podcast is supported by the Icon School of Medicine at Mount Sinai, one of America's leading research medical schools. |
| 0:07.8 | Icon Mount Sinai is the academic arm of the eight hospital Mount Sinai health system in New York City. |
| 0:13.9 | It's consistently among the top recipients of NIH funding. |
| 0:18.0 | Researchers at Icon Mount Sinai have made breakthrough discoveries in many fields vital to |
| 0:23.0 | advancing the health of patients, including cancer, COVID and long COVID, cardiology, neuroscience, and |
| 0:30.4 | artificial intelligence. The Icon School of Medicine at Mount Sinai. We find a way. |
| 0:48.7 | Welcome to the science podcast for October 2nd, 2020. I'm Sarah Presby. Each week, we feature the most interesting news and research published in science and the sister journals. First up, |
| 0:53.4 | we have investigative journalist |
| 0:54.6 | Charles Piller. He talks about his latest story on long-term failures at the FDA to regulate |
| 1:00.6 | clinical trial safety and data integrity. We also hear from machine learning researcher |
| 1:06.0 | Klaus Robert Mueller about an AI that can beat human experts in the sport of curling. Now we have contributing |
| 1:15.4 | correspondent Charles Pillar. He wrote an investigative feature on FDA's serious decline in |
| 1:21.0 | protections for patients and for data integrity. Hi, Charlie. Hey, Sarah. I'm not sure everyone knows that FDA has oversight of |
| 1:29.9 | clinical trials. What exactly is this agency's role with respect to human trials? The FDA is a |
| 1:37.1 | vast agency with many responsibilities, and in this case, it has two elements of control over the quality of clinical trials. |
| 1:47.9 | One is whether patients are properly protected during the trials and also whether the data |
| 1:54.7 | generated from these trials is reliable. |
| 1:57.6 | And in keeping with the important goal of the FDA of approving drugs and |
| 2:04.6 | devices that actually were. |
| 2:07.1 | But as you found in your investigation, the FDA enforcement has been light-handed, slow-moving, |
| 2:13.9 | and secretive. Can you give us some examples that you found of shoddy clinical research |
| 2:18.7 | practices, poor record keeping that you came across in your deep dive into this? |
... |
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