Study raises concerns about reporting of noninferiority trials

March 17, 2015

An examination of the reporting of noninferiority clinical trials raises questions about the adequacy of their registration and results reporting within publicly accessible trial registries, according to a study in the March 17 issue of JAMA.

Noninferiority clinical trials are designed to determine whether an intervention is not inferior to a comparator by more than a prespecified difference (known as the noninferiority margin). Selection of an appropriate margin is fundamental to noninferiority trial validity, yet a point of frequent ambiguity. Given the increasing use of noninferiority trial designs, maintaining high standards for conduct and reporting is a priority, according to background information in the article.

Joseph S. Ross, M.D., M.H.S., of the Yale University School of Medicine, New Haven, Conn., and colleagues examined registration records and results of noninferiority clinical trials posted on, as well as their corresponding publications, for information about the noninferiority margin and statistical analyses. Because does not require registration of noninferiority-specific information, the authors searched MEDLINE for noninferiority trials published between January 2012 and June 2014, then selected publications reporting primary analyses of noninferiority trials indexed with a Clinical identifier. The researchers recorded details on trial design (including specification and justification of the noninferiority margin) and results (including reporting of noninferiority statistical analyses) from both and corresponding publications.

The authors identified and characterized 344 unique trials registered on, published in 338 articles (6 described multiple trials) that reported primary results of noninferiority trials. All publications described noninferiority designs and nearly all (98.8 percent) provided noninferiority margins. However, any justification for choosing margins was provided for only 28 percent. On, approximately one­quarter described noninferiority designs, among which 15 (4.4 percent of total) specified noninferiority margins.

Nearly all publications reported noninferiority analyses and results (99.4 percent). On, 38 percent had posted summary results, among which 76 (22 percent of total) reported that noninferiority analyses were performed and provided appropriate confidence intervals or P values to interpret results.

"Our findings raise concerns about the adequacy of noninferiority trial registration and results reporting within publicly accessible trial registries and highlight the need for continued efforts to improve its quality," the authors write.

They add that even though does not provide specific registration data elements for specifying noninferiority trial designs, it does provide specific elements for reporting noninferiority results. "Nevertheless, modifications may improve reporting and temper the possibility of post hoc distortion of design and margins, facilitating transparency and accountability for noninferiority trial conduct."
(doi:10.1001/jama.2015.1697; Available pre-embargo to the media at

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

The JAMA Network Journals

Related Clinical Trials Articles from Brightsurf:

Nearly 1 in 5 cancer patients less likely to enroll in clinical trials during pandemic
A significant portion of cancer patients may be less likely to enroll in a clinical trial due to the ongoing coronavirus pandemic.

COVID-19 clinical trials lack diversity
Despite disproportionately higher rates of COVID-19 infection, hospitalization and death among people of color, minority groups are significantly underrepresented in COVID-19 clinical trials.

Why we should trust registered clinical trials
In a time when we have to rely on clinical trials for COVID-19 drugs and vaccines, a new study brings good news about the credibility of registered clinical trials.

Inclusion of children in clinical trials of treatments for COVID-19
This Viewpoint discusses the exclusion of children from coronavirus disease 2019 (COVID-19) clinical trials and why that could harm treatment options for children.

Review evaluates how AI could boost the success of clinical trials
In a review publishing July 17, 2019 in the journal Trends in Pharmacological Sciences, researchers examined how artificial intelligence (AI) could affect drug development in the coming decade.

Kidney patients are neglected in clinical trials
The exclusion of patients with kidney diseases from clinical trials remains an unsolved problem that hinders optimal care of these patients.

Clinical trials beginning for possible preeclampsia treatment
For over 20 years, a team of researchers at Lund University has worked on developing a drug against preeclampsia -- a serious disorder which annually affects around 9 million pregnant women worldwide and is one of the main causes of death in both mothers and unborn babies.

Underenrollment in clinical trials: Patients not the problem
The authors of the study published this month in the Journal of Clinical Oncology investigated why many cancer clinical trials fail to enroll enough patients.

When designing clinical trials for huntington's disease, first ask the experts
Progress in understanding the genetic mutation responsible for Huntington's disease (HD) and at least some molecular underpinnings of the disease has resulted in a new era of clinical testing of potential treatments.

New ALS therapy in clinical trials
New research led by Washington University School of Medicine in St.

Read More: Clinical Trials News and Clinical Trials Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to