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Why Should I Register and Submit Results?
- 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 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 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
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:
- See FDAAA 801 Requirements to learn about Responsible Party, Applicable Clinical Trials, and deadlines for registration and results submission
- See the Protocol Data Element Definitions and Basic Results Data Element Definitions to learn about the specific data elements
- See History, Policies, and Laws to learn about other relevant laws, including the Food and Drug Administration Modernization Act
- View the online presentation:
Key FDAAA Issues
Deborah A. Zarin, MD, Director, ClinicalTrials.gov, National Library of Medicine
Discusses key issues in the FDAAA related to registering trials and submitting results (March 2011)
- Key FDAAA Issues (9:23)
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. ClinicalTrials.gov is a registry where organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE.
Selected Trial Registration Laws and Policies
A summary of key laws and policies requiring clinical trial registration is provided in the table below:
|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 a Food and Drug Administration (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 by the World Health Organization (WHO) 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."||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."|
|ICMJE Policy||Publication policy initiated by the International Committee of Medical Journal Editors (ICMJE) 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 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.
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.
- 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.