Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2013 Dec;5(12):713-5.
doi: 10.4103/1947-2714.123266.

Registration of Clinical Trials: Is it Really Needed?

Ameer Aslam  1 , Sameera Imanullah  2 , Mohammad Asim  3 , Ayman El-Menyar  4
Affiliations

Registration of Clinical Trials: Is it Really Needed?

Ameer Aslam et al. N Am J Med Sci. 2013 Dec.

Abstract

Background and aims: Withholding findings of clinical trials for publication or presentation to the regulatory authorities is a major concern. We aimed to address the importance of clinical trial registration and whether it is needed or not.

Discussion: For ethical conduct of clinical trial, registration is an important but debatable issue due to proprietary interest of the pharmaceutical industry. Over the years, investigating agencies uncovered several instances of misconduct during the clinical trial. The International committee of medical journal editors requires registration of trial methodology, but does not require registration of trial results; however, the U.S. Food and Drug Administration Amendments does require researchers to register results.

Conclusion: Prospective registration of clinical trial is mandatory for more transparent research and sustaining the validity of evidence based practice and availability of reliable data. Clinical trials registration has the potential to contribute substantially to improve clinical trial transparency and reducing publication bias and selective reporting.

Keywords: Clinical trials; Ethics; Healthcare; Registration; Research.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: None declared.

References

    1. Viergever RF, Ghersi D. The quality of registration of clinical trials. PLoS One. 2011;6:1–8. - PMC - PubMed
    1. Claxton LD. Scientific authorship. Part 1. A window into scientific fraud? Mutat Res. 2005;589:17–30. - PubMed
    1. Jüni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: Cumulative meta-analysis. Lancet. 2004;364:2021–9. - PubMed
    1. Willyard C. Pfizer lawsuit spotlights ethics of developing world clinical trials. Nat Med. 2007;13:763. - PubMed
    1. Weiss RB, Vogelzang NJ, Peterson BA, Panasci LC, Carpenter JT, Gavigan M, et al. A successful system of scientific data audits for clinical trials. A report from the Cancer and Leukemia Group B. JAMA. 1993;270:459–64. - PubMed