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The emphasis has been on post-marketing phase IV trials.
Phase IV trials are particularly useful in helping to discover and monitor these rare side effects.
Phase IV trials are done after a drug has been approved, officially manufactured, and put on the market.
Post-marketing surveillance, also referred to as phase IV trials may be required to ensure patient safety and drug efficacy.
If many unexpected and severe side effects are detected in the phase IV trials, the drug can be withdrawn or restricted, despite its earlier approval from the FDA.
Phase IV trials are conducted once a new drug has been approved for marketing and is available for prescription by doctors.
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A growing number of drugs go into post-approval "phase-IV" trials.
Over the course of 20 years, the DCRI has managed >3,500 studies in over 65 countries, enrolled >1.2 million patients in nearly 1,000 Phase I-IV trials and outcomes projects, and generated >10,000 peer-reviewed publications.
More than 500 patients per group in large phase-IV trials would be necessary.
This work aims to inform subsequent phase II-IV trials and systematic reviews of effectiveness.
A non-inferiority margin of 12% was defined based on the results observed in the tocilizumab-IV trials.
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