Policies, Procedures and Guidelines

Clinicaltrials.gov Registration and Results Disclosure Policy

Chancellor Approved 2/18/2019

Position Statement

WU requires the registration and disclosure of results for clinical research studies in accordance with applicable law and NIH policy. In addition, this policy recognizes International Committee of Medical Journal Editors (ICMJE) recommendations to register clinical trials and the Center for Medicare and Medicaid Services (CMS) requirements for a ClinicalTrials.gov study identification number (NCT#) when billing routine costs associated with applicable clinical trials.

Requirements

Which studies need to be registered and have results disclosed on clinicaltrials.gov?

The FDA and DHHS regulations mandate registration and results reporting for applicable clinical trials (ACTs). ACTs generally include interventional clinical studies of drugs, biologics or devices that are subject to the FDA regulations. (http://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhichTrialsMustBeRegistered).

NIH policy mandates registration and results reporting for clinical trials that are funded in whole or in part by NIH, even if they are not ACTs. NIH defines a clinical trial (NIH-CT) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes(http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials).

The policy of the ICMJE requires the registration of all “clinically directive” trials, trials that test a clinical hypothesis about health outcomes. These include any trials that assign human subjects to intervention and comparison groups to study cause-and-effect relationships between interventions and health outcomes. Participating journals may refuse publication of a trial, if it is not registered.

For applicable, investigator-initiated clinical studies, the Principal Investigator must: (1) register the study in clinicaltrials.gov; and (2) report summary results in clinicaltrials.gov. Failure to register and submit results within the required timeframe could lead to sanctions from the University (refer to the Oversight/Sanctions section below).

Procedures

  1. A Principal Investigator, who initiates or conducts an applicable investigator-initiated clinical study, must ensure that registration, required record updates, and results reporting are completed in a timely matter, according to the DHHS regulations, NIH policy, and this policy.
    • Register the clinical trial before the first subject is enrolled;
    • Update clinicaltrials.gov records at least once every 12 months (Recruitment status and Primary Completion Date). It is recommended that the Record Verification Date be updated at least every 6 months, even if there were no changes;
    • Submit results related to the study’s primary endpoint to ClinicalTrials.gov no later than 12 months after the Primary Completion Date.
  2. The Center for Clinical Studies (CCS) is available to provide assistance with account request/log-in, determination of which studies need to be registered on clinicaltrials.gov, and other types of administrative assistance related to the registration of clinical studies on ClinicalTrials.gov. The Siteman Cancer Center provides support for Clinicaltrials.gov registration and results disclosure for all cancer-related clinical trials. However, the researchers are responsible for the results reporting aspect of this policy, as this is not an administrative task, but a cognitive and scientific task. The PI and/or the study statistician should be directly involved and responsible for results reporting.

Why?

The ClinicalTrials.gov study registry was launched in February 2000 in response to US federal law requiring the NIH to establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions in a form that can be readily understood by members of the public. The database later included other registration requirements such as the International Committee of Medical Journal Editors (ICMJE) policy. The US Food and Drug Administration Amendments Act of 2007 (FDAAA) further extended the scope and legal requirements of the ClinicalTrials.gov registry, and mandated the creation of a results database, which became operational in September 2008. Regulations for implementing the FDAAA, which were issued by DHHS in September 2016 and became effective on January 18, 2017, clarified ambiguous statutory provisions, and expanded the scope and requirements of the results database considerably. To support the overall mission of the trial reporting system beyond its legal mandates, The NIH requires and encourages registration and results reporting of all interventional biomedical or behavioral clinical research studies.

Failure to meet the requirements could result in financial risk and reputational harm to the University and the Principal Investigator. The FDA may impose fines of ~$12,000 per day per trial and the NIH can withhold funding from the Investigator and/or the institution.

Oversight/Sanctions

The primary responsibility for registration and results reporting of clinical studies on ClinicalTrials.gov resides with the Principal Investigator. Registration and results disclosure of applicable clinical studies by Principal Investigators will be confirmed during any quality assurance activity.

Noncompliance with the DHHS regulations or NIH policy to submit results for an ACT or NIH-CT (in general, no later than 12 months after the Primary Completion Date, which is defined as the date on which data collection is complete for the primary outcome measures), or repeated violations of the DHHS regulations, NIH policy, or this policy, will be referred to the Vice Chancellor for Research (VCR) for possible sanctions, which may include, withdrawal or suspension of research privileges, embargo of the data for research or publication, financial penalties, disciplinary action or other corrective action deemed appropriate by the VCR, in consultation with the relevant Dean and/or head of the department.