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Clinical Trials Registration


Clinical Trial overview


 What is a Clinical Trial?

INTERVENTIONAL STUDY (or Clinical Trial):  A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. 

What is not a Clinical Trial?

  • Retrospective case reports of series of de-identified patients (not to exceed 3 cases)
  • Retrospective analysis of de-identified patients who underwent diagnostic testing to identify prevalence, incidence, specificity and/or sensitivity of existing tests
    • Requires IRB review as exempt or minimal risk protocol
  • De-identified clinical surveys which do not impact diagnosis or management
    • Requires IRB review as exempt or minimal risk protocol

Why register my trial?

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]

 


Clinical Trial Registration Guidance


 

Where should I register my trial? 

ClinicalTrials.gov is an online resource (also referred to as a "registry") that provides the public, researchers, patients and their family members, and health care professionals access to information on publicly and privately supported clinical studies. The website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted/registered to ClinicalTrials.gov when they begin, and the information is updated throughout the study. In some cases, results of the study are submitted after the study ends. All clinical trials receiving federal grant support must be registered to meet compliance with the law.

What needs to be registered?

  1. Clinical trials receiving federal grant support.
  2. Clinical Trials of Drugs and Biologics: Controlled, clinical investigations of a product subject to FDA regulations.
  3. Clinical Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.
  4. The International Committee of Medical Journal Editors (ICMJE) requires certain research studies to be registered at ClinicalTrials.gov in order to be considered for publication in ICMJE member journals and other publications that adhere to ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals: “Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” This definition includes Phase I trials. Interventions include “any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes).” Health outcomes include “any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. The ICMJE accepts registration in any registry that is a primary register of theWHO International Clinical Trials Registry Platform (ICTRP) or in gov, ICMJE endorses these registries because they meet several criteria. They are accessible to the public at no charge, open to all prospective registrants, managed by a not-for-profit organization, have a mechanism to ensure the validity of the registration data, and are electronically searchable. An acceptable registry must include the minimum 20-item trial registration dataset .See http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/

How do I register?

  1. Request a user log on name and temporary password, by sending an email to wandless@uiwtx.edu
    1. Place "clinicaltrials.gov registration" in the subject line.
    2. Include in the message your name, telephone number and email address
  2. You will then receive an email with your login name and a temporary password.
  3. Go to: https://register.clinicaltrials.gov/ and enter your user name.
    1. In the “Organization” field, type “UniversityIW”
    2. Change your password under "User Account" on the Main Menu page.
  4. To register a study, on the Main Menu page, under “Protocol Record”, click "Create" and complete the study description template.
  5. Once complete, submit the study.
  6. The Office of Research Development will verify the entry and approve it for release to the clinicaltrials.gov registry.

Do I need to do anything once I register my study?

  1. Make periodic updates (e.g., study completed) as needed.
  2. Submit any adverse events. Submission of adverse events to the IRB separately may be required as well.
  3. Submit basic study results and periodic updates during and at the end of the trial

 

For more information contact: 

Dr. Ana Wandless-Hagendorf at (210) 805-3036 or wandless@uiwtx.edu

 Visit http://prsinfo.clinicaltrials.gov/