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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 and Benefits for Various Groups

Trial Registry Purposes for Various Groups
Registry Purpose Group That Benefits
Fulfill ethical obligations to participants and the research community Patients, the general public, the 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, the research community
Help institutional review boards (IRBs) determine the 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 and Benefits for Various Groups

Results Database Purposes for Various Groups
Results Database Purpose Group That Benefits
Provide a public record of basic study results in a standardized format Researchers, journal editors, IRBs, ethicists
Promote the fulfillment of ethical obligations to participants and the overall contribution of research results to medical knowledge Patients, the general public, the research community
Reduce publication and outcome reporting biases Users of the medical literature
Facilitate systematic reviews and other analyses of the research literature Researchers, 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

The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801). The Final Rule has been in effect since January 18, 2017. For more information on the Final Rule:

Required for Journal Publication

The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition of the publication of research results generated by a clinical trial. To fulfill this obligation organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE to ClinicalTrials.gov or a WHO primary registry. The ICMJE expects authors to meet all results reporting requirements of their funding and regulatory agencies. If there are no such reporting requirements, the ICMJE encourages authors to submit results information to the same database on which their trials are registered.

See the ICMJE section of the Support Materials page or visit the ICMJE Web site.

Selected Trial Registration Laws and Policies

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

Selected Trial Registration Laws and Policies
Name Type Intervention Type Registration
Policy Scope
Results Submission
Policy Scope
Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) U.S. Federal regulation implementing FDAAA 801 effective in 2017 Drug, biological, and device products Clinical trials of a Food and Drug Administration (FDA)-regulated drug, biological, or device product other than Phase 1 (drug/biological products) or small feasibility studies (device products) Same scope as registration
NIH Policy on the Dissemination of NIH-funded Clinical Trial Information

National Institutes of Health (NIH) policy effective in 2017 Any (includes drug, biological, and device products, as well as surgical procedures, and behavioral interventions) Clinical trials funded in whole or in part by NIH Same scope as registration
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) U.S. Federal law enacted in 2007 Drug, biological, and device products Controlled clinical investigations of an FDA-regulated drug, biological, or device product, other than Phase 1 (drug/biological products) or small feasibility studies (device products) Same scope as registration, but interventional studies of FDA-approved drug, biological, or device products
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects International policy initially adopted by the World Medical Association General Assembly in 1964; last amended in 2013 Any (includes drug, biological, and device products, as well as surgical procedures, and behavioral interventions) "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 biological products 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 by the World Health Organization (WHO) in 2006 and affirmed by the signatories of the Joint Statement on Public Disclosure of Results from Clinical Trials Any (includes drugs, biological, and device products, as well as surgical procedures, and behavioral treatments) "The registration of all interventional trials is a scientific, ethical and moral responsibility." The 2015 WHO Statement on the Public Disclosure of Clinical Trials Results specifies that "[t]here is an ethical imperative to report the results of all clinical trials, including those of unreported trials conducted in the past."
International Committee of Medical Journal Editors (ICMJE) Policy Publication policy initiated by the International Committee of Medical Journal Editors (ICMJE) in 2004 Any (includes drugs, biological, and device products, as well as surgical procedures, and behavioral treatments) All interventional studies, including Phase 1 studies; defines criteria for "acceptable registries" The ICMJE expects authors to meet results information submission requirements "of their funding and regulatory agencies" and "encourages... results reporting even when not required."
Section 113 of the Food and Drug Administration Modernization Act U.S. Federal law enacted in 1997 Drugs and biological products Efficacy trials of FDA-regulated investigational new drugs for "serious or life-threatening diseases and conditions" 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]

See History, Policies, and Laws for more information.

Learn More

  • Submit Studies: This section of the site is a resource for clinical research professionals, sponsors, and investigators who are responsible for registration and results submission to ClinicalTrials.gov.
  • How to Register Your Study: Learn about registering studies.
  • How to Submit Your Results: Learn about submitting study results.
This page last reviewed in May 2018