They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. The final rule for clinical trials registration and results information submission (42 cfr part 11) specifies requirements for submitting clinical trial information to clinicaltrials.gov. Baseline characteristics data preparation checklist overview Certain agreements and results point of contact Patients treated with gem/cis had an improvement in os (8.1 vs 11.7 months, p<0.001) and pfs (5.0 vs
The food and drug administration amendments act of 2007 (fdaaa) established a requirement for certain clinical trials to be registered at trial initiation and to report summary results after trial completion in the public registry and results database called clinicaltrials.gov. The national library of medicine (nlm) has launched an effort to modernize clinicaltrials.gov We will be continually delivering improvements throughout the modernization effort.
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