Research Letter
February 2016

Drug Discontinuation and Follow-up Rates in Oral Antithrombotic Trials

Author Affiliations
  • 1Retired
  • 2HeartDrug Research, Towson, Maryland
  • 3Department of Cardiology, Bakoulev Center for Cardiovascular Surgery, Academy of Medical Sciences, Moscow, Russia
  • 4Clinical Trials Center, Division of Cardiology, Dong-A University, Pusan, South Korea
  • 5Department of Neurology, Johns Hopkins University, Baltimore, Maryland

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA Intern Med. 2016;176(2):257-259. doi:10.1001/jamainternmed.2015.6769

Missing data are common, challenging the validity of trial results.1 However, it is unclear how to characterize the extent of missing data. The CONSORT statement2 specifies reporting number lost to follow-up but does not define it operationally. The US Food and Drug Administration (FDA) recently published a review3 providing the follow-up completeness by a specific methodology for major oral antithrombotic trials. In this report, we compare the FDA follow-up rates with the published rates. We also analyze drug discontinuation rates as a possible contributory cause of incomplete follow-up and compare them with the outcomes because excessive incomplete follow-up may cause the end point rate difference, rather than representing true drug effect.

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