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?
• Learn More

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 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

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 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

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 (9:23)
  Deborah A. Zarin, M.D., Director, ClinicalTrials.gov, NLM
  Discusses key issues in the Food and Drug Administration Amendments Act related to registering trials and submitting results.
  
  

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:

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
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; amended in 2008	Any (includes drugs, biologics, devices, surgical procedures, and behavioral treatments)	"Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject." (Para 19)	"Authors 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 30.)
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

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.