How often pharmaceutical companies actually perform postmarketing trials (phase IV) are contained in a report from Cutting Edge Information, an industry intelligence firm. The top 20 pharmaceutical companies initiate phase IV trials for 87% of new products, while 92% of mid-sized companies will perform the postmarketing studies. Small companies conduct the trials only 69% of the time. The report, entitled Phase IV Clinical Trials: Post-Marketing Study Management Structure, Strategy, and Benchmarks, is available on-line at www.postmarketingtrials.com. It includes clinical trial performance measures such as cycle times, resource-based measures, and efficiency or operational metricssuch as patient retention rates and data errors. Average per-patient clinical trial costs by therapeutic area are also included in the new report.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.