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Sunday, April 5, 2015

Compliance with Results Reporting at ClinicalTrials.gov

By Monique L. Anderson and others
N Engl J Med 2015; 372:1031-1039
March 12, 2015
DOI: 10.1056/NEJMsa1409364

Here are two excerpts:

The human experimentation that is conducted in clinical trials creates ethical obligations to make research findings publicly available. However, there are numerous historical examples of potentially harmful data being withheld from public scrutiny and selective publication of trial results. In 2000, Congress authorized the creation of the ClinicalTrials.gov registry to provide information about and access to clinical trials for persons with serious medical conditions. In 2007, Section 801 of the Food and Drug Administration Amendments Act (FDAAA) expanded this mandate by requiring sponsors of applicable clinical trials to register and report basic summary results at ClinicalTrials.gov. Such trials generally include all non–phase 1 interventional trials of drugs, medical devices, or biologics that were initiated after September 27, 2007, or before that date but that were still ongoing as of December 26, 2007, have at least one U.S. research site, or are conducted under an investigational-new-drug application or an investigational-device exemption. The FDAAA also mandates that trial results be reported by the sponsor within 1 year after the completion of data collection for the prespecified primary outcome (primary completion date) or within 1 year after the date of early termination, unless legally acceptable reasons for the delay are evident.


In conclusion, despite ethical mandates, statutory obligations, and considerable societal pressure, most trials that were funded by the NIH or other government or academic institutions and were subject to FDAAA provisions have yet to report results at ClinicalTrials.gov, whereas the medical-products industry has been more responsive to the legal mandate of the FDAAA. However, industry, the NIH, and other government and academic institutions all performed poorly with respect to ethical obligations for transparency.

The entire article is here.