How are the results of a clinical trial reported?
Results data are submitted online through the PRS and are displayed with the corresponding registered summary protocol information at ClinicalTrials.gov. Results reporting in the database will commonly occur prior to journal publication.
What does noninferiority margin mean?
The term ‘non-inferiority’ is now well established, but if taken literally could be misleading. In fact a non- inferiority trial aims to demonstrate that the test product is not worse than the comparator by more than a pre-specified, small amount. This amount is known as the non-inferiority margin, or delta (∆).
What is a normal noninferiority margin?
A noninferiority margin (1.31%, M2) was defined for the point‐estimate method to preserve 50% of the pooled point estimate (2.62%, M1).
What is a superiority margin?
There is a percentage above 70% at which the difference between the two treatments is no longer considered ignorable. The difference between these two percentages is called the margin of superiority.
Do clinical trial results have to be public?
The court order requires the government to collect and release nearly ten years’ worth of clinical trial results that should have been public under the law.
What is the main difference between non-inferiority and equivalence trials conceptually and statistically?
Non-inferiority trials aim to show that the new drug is no worse than standard treatment. Equivalence trials aim to show the new treatment is no better and no worse. An equivalence boundary should be set before the trial. This is the definition of what would be the minimum important difference between the treatments.
Can a superiority trial show non-inferiority?
A superiority trial is designed to show that a new treatment is better than an active control or placebo. A non-inferiority trial is different as it is designed not to show that treatments are equal, or ‘not different’, but that the new treatment is not unacceptably worse than, or ‘non-inferior’ to, an active control.
What is a non-inferiority p value?
In non-inferiority trials, investigators are interested in whether new treatment is non-inferior to standard treatment. Only the non-inferior margin to the right side of unity on the forest plot is specified. Therefore, the significance level is usually set as a one-sided p value of 0.025.
Where do I find the results of a clinical trial?
For certain clinical trials subject to the requirements of Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), Responsible Parties must submit scientific and administrative information about the results of the trial to the ClinicalTrials.gov results database. See FDAAA 801 and the Final Rule for more information.
How are noninferiority margins determined in a clinical trial?
Choice of the noninferiority margin is critical in designing noninferiority trials. One reasonable way to define a margin is to base it on some proportional effect that the active control has shown over placebo in previous studies. However, the margin should be based on both statistical reasoning and clinical judgment.
Is there a final rule for ClinicalTrials.gov?
In addition, ClinicalTrials.gov facilitates linking to associated journal articles for additional information. The final rule provides detailed discussions of the proposals in the NPRM, relevant public comments and other considerations, and final requirements.
Who is the responsible party for a clinical trial?
The responsible party for an applicable clinical trial (ACT) must register the trial and submit results information. The responsible party is defined as: The final rule specifies that there must be one (and only one) responsible party for purposes of submitting information about an applicable clinical trial.