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Why Should I Register and Submit Results?

Contents

What Is the Purpose of Trial Registration and Results Submission?

Registering clinical trials when they begin, providing timely updates, submitting summary results, and making this information publicly available fulfills a number of purposes and benefits a variety of people.

Trial Registry Purposes for Various Groups

Trial Registry Purposes for Various Groups
Registry Purpose Group That Benefits
Fulfill ethical obligations to participants and community Patients, general public, research community
Provide information to potential participants and referring clinicians Patients, clinicians
Reduce publication bias Users of the medical literature
Help editors and others understand the context of study results Journal editors, users of the medical literature
Promote more efficient allocation of research funds Granting agencies, research community
Help institutional review boards (IRBs) determine appropriateness of a research study IRBs, ethicists
Reference to CHEST Registering a Trial paper
Source: Zarin DA, Keselman A. Registering a clinical trial in ClinicalTrials.gov. Chest. 2007;131(3):909-12. [Full Text]

Results Database Purposes for Various Groups

Results Database Purposes for Various Groups
Results Database Purpose Group That Benefits
Provide public record of basic study results in a standardized format Researchers, journal editors, institutional review boards, and ethicists
Promote fulfilling of ethical responsibility to participants; use of research results to contribute to medical knowledge Patients, general public, and research community
Mitigate "publication" and "outcome reporting" biases Users of medical literature
Facilitate systematic reviews and other analyses of the research literature Researchers and policymakers
Reference to CHEST Reporting Basic Results paper
Source: Tse T, Williams RJ, Zarin DA. Reporting "Basic Results" in ClinicalTrials.gov. Chest. 2009;136(1):295-303. [Full Text]

Why Do I Need To Register My Trial and Submit Results to ClinicalTrials.gov?

Required by Law

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices. For more information:

Required for Journal Publication

The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for the publication of research results generated by a clinical trial. ClinicalTrials.gov is a registry where organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE.

See ICMJE section of Support Materials or visit http://www.icmje.org.

Selected Trial Registration Laws and Policies

A summary of key laws and policies requiring clinical trial registration are shown in the table below:

Selected Trial Registration Laws and Policies
Name Type Intervention Type Registration
Policy Scope
Results Submission
Policy Scope
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) U.S. Federal law enacted in 2007 Drugs, biologics, and devices Controlled clinical investigations of an FDA-regulated drug, biologic, or device, other than Phase 1 (drugs/biologics) or small feasibility studies Same scope as registration, but interventional studies of FDA approved drugs, biologics, or devices
WMA 2013 Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects International policy initially adopted by the World Medical Association (WMA) General Assembly in 1964; last amended in 2013 Any (includes drugs, biologics, devices, surgical procedures, and behavioral treatments) "Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject." (Para 35) "Researchers have a duty to make publicly available the results of their research on human subjects... Negative and inconclusive as well as positive results should be published or otherwise made publicly available." (Para 36.)
Clinical Trials Directive (2001/20/EC), Article 11 (and associated Regulations and Guidelines) European Union directive adopted in 2001 Drugs and biologics Phase 2–4 adult trials and Phase 1–4 pediatric trials Same scope as registration (includes products without marketing authorization applications)
WHO International Clinical Trials Registry Platform International policy initiated in 2006 Any (includes drugs, biologics, devices, surgical procedures, and behavioral treatments) "The registration of all interventional trials is a scientific, ethical and moral responsibility." N/A
ICMJE Statement Publication policy initiated in 2004 Any (includes drugs, biologics, devices, surgical procedures, and behavioral treatments) All interventional studies, including Phase 1 studies; defines criteria for "acceptable registries" N/A
Section 113 of the Food and Drug Administration Modernization Act U.S. Federal law enacted in 1997 Drugs and biologics Efficacy trials for "serious or life threatening diseases or conditions" regulated by FDA N/A
Reference to CHEST Registering a Trial paper
Adapted from: Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. JAMA. 2007;297(19):2112-20.

Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database—update and key issues. N Engl J Med. 2011;364(9):852-60. [Full Text]

For more information see History, Policies, and Laws

Learn More

  • Submit Studies. This section of the site is a resource for clinical research professionals, sponsors, or investigators who are responsible for registration and results submission to ClinicalTrials.gov.
  • How to Register Your Study. Learn more about registering studies.
  • How to Submit Your Results. Learn more about registering and submitting study results.
This page last reviewed in November 2013