The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number …

Jun 27, 2018 · 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.

Welcome to the ClinicalTrials.gov Protocol Registration and Results System (PRS).

Based on the results of these phase 3 trials, secukinumab received FDA approval in January 2016 for the treatment of active PsA and AS in adult patients. Therefore, treatment with secukinumab may …

In clinical trials, the most commonly reported adverse reactions are injection site reactions (including injection site pain, swelling, erythema and pruritus) and headaches.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will …

Baseline Characteristics Data Preparation Checklist Overview: The Baseline Characteristics module is a tabular summary of data for each demographic and base-line measure by arm or comparison group …

Given that all efficacy assessments are considered as exploratory only and are intended to inform future trials, no multiplicity adjustment shall be applied to these exploratory analyses.

To date, there have been only three trials that have used ketamine as an augmentation agent in the treatment of depression. One such trial [11] used a single dose of iv ketamine augmentation in …

Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is conducted and data are generated and biological specimens are collected, documented (recorded), …