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Practical Guide to Clinical Trial Publication

To identify the key insights or developments described in this article
1 Credit CME

As with airplane concepts, clinical trials fly or crash based on design engineering. Executing a well-designed trial that asks a clinically important question of a common problem is harder than it sounds. Vertiginous uplift requires gravity-defying kinetics by a dedicated and coordinated team, akin to climbing mountains. The final yards (writing and publishing) are, like the summit, the hardest, requiring commitment, focus, and an eye on the end game. Others in this fine series of articles on scientific endeavor covered the conceptualization, initiation, planning, and aggregation of trial data. Now it is time to publish (Box). What makes a trial stand out to editors and referees? Simplicity, as in nature, is the most elegant form to achieve.

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Article Information

Corresponding Author: Des C. Winter, MD, Division of Surgery, St Vincent’s University Hospital, Elm Park, Dublin 04, Ireland (des.winter@gmail.com).

Published Online: October 26, 2022. doi:10.1001/jamasurg.2022.4910

Conflict of Interest Disclosures: Dr Haukoos reported personal fees from JAMA Surgery, Annals of Emergency Medicine, and the American College of Emergency Physicians outside the submitted work. No other disclosures were reported.

References
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Enhancing the Quality and Transparency of Health Research (EQUATOR) Network. Accessed February 2022. https://www.EQUATOR-network.org
2.
Chan  A-W , Tetzlaff  JM , Altman  DG ,  et al.  SPIRIT 2013 statement: defining standard protocol items for clinical trials.   Ann Intern Med. 2013;158(3):200-207. doi:10.7326/0003-4819-158-3-201302050-00583PubMedGoogle ScholarCrossref
3.
Schulz  KF , Altman  DG , Moher  D ; CONSORT Group.  CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.   Ann Intern Med. 2010;152(11):726-732. doi:10.7326/0003-4819-152-11-201006010-00232PubMedGoogle ScholarCrossref
4.
Piaggio  G , Elbourne  DR , Pocock  SJ , Evans  SJ , Altman  DG ; CONSORT Group.  Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement.   JAMA. 2012;308(24):2594-2604. doi:10.1001/jama.2012.87802PubMedGoogle ScholarCrossref
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Campbell  MK , Piaggio  G , Elbourne  DR , Altman  DG ; CONSORT Group.  Consort 2010 statement: extension to cluster randomised trials.   BMJ. 2012;345:e5661. doi:10.1136/bmj.e5661PubMedGoogle ScholarCrossref
6.
Cook  JA , Julious  SA , Sones  W ,  et al.  DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial.   BMJ. 2018;363:k3750. doi:10.1136/bmj.k3750PubMedGoogle ScholarCrossref
7.
International Committee of Medical Journal Editors. Accessed February 2022. https://www.icmje.org/
8.
Senn  S .  Testing for baseline balance in clinical trials.   Stat Med. 1994;13(17):1715-1726. doi:10.1002/sim.4780131703PubMedGoogle ScholarCrossref
AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 credit toward the CME [and Self-Assessment requirements] of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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