Transforming Cancer Clinical Trials for Better. Faster Results
Transforming Cancer Clinical Trials for Better. Faster Results
Thought this was worth sharing.
It is a Q&A with NCI - National Cancer Institute- Director Monica Bertagnolli, M.D., and Deputy Director for Clinical and Translational Research James H. Doroshow, M.D.. They talk about the challenges of clinical trials and steps NCI is taking to improve their effectiveness.
(They are federal- part of the National Institutes of Health (NIH), one of 11 agencies that make up the Department of Health and Human Services (HHS). Part of their work is ‘partnering with industry, private philanthropic organizations, other federal agencies, and other national and foreign institutions’ to engage in cancer research. ‘NCI has a broad array of programs that support clinical research, from early-stage clinical trials to large randomized trials.'
Though CytoDyn had additional problems- it seems that clinical trial data collection is a problem across the board. Maybe they have FDA’s ear.
Some of the responses:
- Unfortunately, the old model of clinical trials is not meeting our current needs. As NCI conveyed in the Fiscal Year 2024 Annual Plan and Budget Proposal for Fiscal Year 2024, we need to make a big investment to expand and modernize cancer clinical trials to more quickly produce the prevention, detection, and treatment measures that will end cancer as we know it.
- A big area where we think we can make a real difference is in clinical trials data. Researchers collect enormous amounts of data in clinical trials. Our tendency is to want every piece of data that might reveal an important insight. Unfortunately, the tradeoff is that obtaining every piece of data costs time and money. But we’ve found that much of the data we collect, in fact, have no effect on outcome, are unnecessary, and go unused.
- We’ve been working on the question of how to improve our clinical trials for some time now. We determined that we could develop flexible, faster, simpler, less expensive, and higher impact clinical trials by focusing on four key areas: streamlining processes for trial design and execution, focusing on essential endpoints, setting up trials in a way that broadens rather than limits participant access, and increasing efficiency of data collection.’
Transforming Cancer Clinical Trials for Better. Faster Results
Thought this was worth sharing.
It is a Q&A with NCI - National Cancer Institute- Director Monica Bertagnolli, M.D., and Deputy Director for Clinical and Translational Research James H. Doroshow, M.D.. They talk about the challenges of clinical trials and steps NCI is taking to improve their effectiveness.
(They are federal- part of the National Institutes of Health (NIH), one of 11 agencies that make up the Department of Health and Human Services (HHS). Part of their work is ‘partnering with industry, private philanthropic organizations, other federal agencies, and other national and foreign institutions’ to engage in cancer research. ‘NCI has a broad array of programs that support clinical research, from early-stage clinical trials to large randomized trials.'
Though CytoDyn had additional problems- it seems that clinical trial data collection is a problem across the board. Maybe they have FDA’s ear.
Some of the responses:
- Unfortunately, the old model of clinical trials is not meeting our current needs. As NCI conveyed in the Fiscal Year 2024 Annual Plan and Budget Proposal for Fiscal Year 2024, we need to make a big investment to expand and modernize cancer clinical trials to more quickly produce the prevention, detection, and treatment measures that will end cancer as we know it.
- A big area where we think we can make a real difference is in clinical trials data. Researchers collect enormous amounts of data in clinical trials. Our tendency is to want every piece of data that might reveal an important insight. Unfortunately, the tradeoff is that obtaining every piece of data costs time and money. But we’ve found that much of the data we collect, in fact, have no effect on outcome, are unnecessary, and go unused.
- We’ve been working on the question of how to improve our clinical trials for some time now. We determined that we could develop flexible, faster, simpler, less expensive, and higher impact clinical trials by focusing on four key areas: streamlining processes for trial design and execution, focusing on essential endpoints, setting up trials in a way that broadens rather than limits participant access, and increasing efficiency of data collection.’
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