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Why Should I Register and Submit Results?
Contents
- What Is the Purpose of Trial Registration and Results Submission?
- Why Do I Need to Register My Trial and Submit Results to ClinicalTrials.gov?
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
| 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 |
| 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 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 |
| 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:
- See the Final Rule Information page for details on data submission requirements for 42 CFR Part 11, including the formatting of certain types of clinical trial information.
- View the archived content for the Final Rule Webinar Series, designed to assist responsible parties further their understanding of the Final Rule.
- See the Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (PDF) (June 2018) for complete statutory definitions and more information on the meaning of applicable clinical trial.
- View Frequently Asked Questions (FAQs) about the Final Rule (42 CFR Part 11).
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires responsible parties to register clinical trials and submit summary results to ClinicalTrials.gov. The law applies to certain clinical trials of drug, biological, and device products and has been in effect since September 27, 2007.
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:
| 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 [PDF] | 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 |
| 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.