The proposed rule for U.S. clinical trial registration and results submission.

This article calls attention to an open public comment period regarding a proposed new rule from the Department of Health and Human Services that affects clinical trial registration and results reporting.

[1]  R. Simes Publication bias: the case for an international registry of clinical trials. , 1986, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[2]  I Chalmers,et al.  Underreporting research is scientific misconduct. , 1990, JAMA.

[3]  Weeks Ea,et al.  Is it worth the trouble? The new policy on dissemination of information on off-label drug use under the Food and Drug Administration Modernization Act of 1997. , 1999 .

[4]  A. McCray Better Access to Information about Clinical Trials , 2000, Annals of Internal Medicine.

[5]  J. Ioannidis,et al.  Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement , 2004, Annals of Internal Medicine.

[6]  Ana Marusic,et al.  Clinical trial registration: looking back and moving ahead , 2007, The Lancet.

[7]  R. Rosenthal,et al.  Selective publication of antidepressant trials and its influence on apparent efficacy. , 2008, The New England journal of medicine.

[8]  Kay Dickersin,et al.  Outcome reporting in industry-sponsored trials of gabapentin for off-label use. , 2009, The New England journal of medicine.

[9]  E. Perez,et al.  Evaluation of the value of attribution in the interpretation of adverse event data: a North Central Cancer Treatment Group and American College of Surgeons Oncology Group investigation. , 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[10]  Nicholas C. Ide,et al.  The ClinicalTrials.gov results database--update and key issues. , 2011, The New England journal of medicine.

[11]  K. Uhlig,et al.  Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications–a cross-sectional study , 2013, BMJ Open.

[12]  Tom Jefferson,et al.  Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments , 2014, BMJ : British Medical Journal.

[13]  F. Collins,et al.  Sharing and reporting the results of clinical trials. , 2015, JAMA.

[14]  Daniele Senzani,et al.  Public Law , 1993, Lessons of the Swaps Litigation.