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FDA Releases Draft Guidance On Decentralized Clinical Trials
The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices. Check out the key takeaways related to remote trial visits, digital health technologies, and more. The public comment period ends August 1, 2023.
Leveraging AI In Drug Discovery To Treat MS & Other Autoimmune Diseases
The advancement of artificial intelligence and machine learning algorithms means we can use large pools of genetic data to identify potential risk factors and disease-causing genes for multiple sclerosis and other autoimmune diseases. This author shares a three-pronged approach to analyzing data for AI algorithms, pitfalls to avoid, and AI for silico modeling.
Phase 1 Strategies To Optimize Orphan Drug Development
While evidence of clinical activity is often sought and collected during Phase 1 trials, it is not typically the primary trial endpoint. But in later-stage trials such as a Phase 1b dose expansion study, there are opportunities to collect additional critical data that will help to guide further development. This includes clinical activity, biomarker and genetic mutation assessments, and preliminary impact in combination therapy.
Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials
The benefits of real-world data (RWD) have been so promising, the FDA now recognizes RWD — and corresponding real-world evidence (RWE) — as valid tools for monitoring the safety of products post-market and, in some cases, for making regulatory approval decisions. At Freenome, we first integrated the use of RWD during a clinical study launched in 2022 for the early detection of multiple cancers. Along the way, we’ve discovered several benefits RWD can bring to any clinical research program.
AI-Driven Medtech Begins To Deliver On Its Potential
The successful use of artificial intelligence (AI) has been a long time coming. Today, more than 530 AI/ML-enabled medical devices have been authorized by the FDA. This article highlights some promising examples.
Is Technology The New Science Of Outsourcing?
That’s the abstruse thought with which I left the 2023 CDMO Leadership Awards ceremony in Manhattan. I’ve subsequently tried to sort this out by referring back to a series of interviews I did with CDMO leaders at the event. I think now I can explain this to readers.
Why We Should Care About Rare Disease Research
Public support, through raising awareness and highlighting the challenges faced by those with rare diseases, is essential in driving progress forward. I encourage everyone to join the conversation and help spread the word about the importance of finding treatments for under-represented populations.
New FDA Guidance: Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics
On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). The move highlights some of the limitations that have been identified with the accelerated approval pathway and provides insight into the rationale for new FDA draft guidance.
Recent FDA Inspections In India Indicate New Focus On Tablet Press Operations
Over the past few years, the FDA investigators in India have shifted their focus away from laboratory and data manipulation and toward a closer look at tablet press operations. The new interest centers on critical process parameters, the automatic weight control system, and more.
A Day In The Life Of A Wannabe Clinical Trial Participant: Desperately Seeking Recruitment
Over 80% of clinical trials experience low or slow enrollment. And to compound the issue, more than 90% of sites have said they do not have adequate staff to perform recruitment activities. No wonder Leanne Woehlke's attempt at becoming a trial participant didn't pan out quite as she expected.