Tag Archive: ClinicalTrials.gov

Third Thursdays with the ICTR: Postponed until June 20th


  This has been rescheduled; the new date is June 20th. If you are still interested in attending, please email us at ictr@jhmi.edu or register. We apologize for any inconvenience this may cause. Please check our calendar for other events.   ClinicalTrials.gov Program Meeting the Demand for Transparency through ClinicalTrials.gov Compliance Speakers Aliya Lalji & Anthony Keyes will discuss the evolving enforcement measures by the NIH and FDA and the new guidelines of the Common Rule. They will also provide updates on ClinicalTrials.gov requirements for new and existing users. Register: https://june2019thirdthurs.eventbrite.com/ Related Links: https://ictr.johnshopkins.edu/ThirdThursdays https://ictr.johnshopkins.edu/clinicaltrials-gov   This educational session qualifies … Continue reading

Selected Publications


Final Rule Federal Register Notice: HHS Final Rule Federal Register Vol. 81, No 183, September 21, 2016 Federal Register Notice: NIH Policy Summary Table: HHS Final Rule and NIH Policy Summary of Changes: HHS Final Rule and NIH Policy JAMA: Toward a New Era of Trust and Transparency in Clinical Trials NEJM: The Final Rule for US Clinical Trial Registration and Results Information Submission NIH Director’s Blog: Clinical Trials – Sharing of Data and Living Up to Our End of the Bargain NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information Other Publications Anderson ML, Chiswell K, Peterson ED, … Continue reading

Legacy and Terminated Studies


Legacy Studies When entering Basic Results for legacy studies (i.e. studies starting 2007 and earlier) with limited data accessibility or older studies that changed significantly from the time that they were first registered, one may attempt to punt via adding a link to the publication preceded by the following descriptive text (edit text as needed) under the “Basic Results/Limitations and Caveats” section (note: there is no guarantee this will be accepted by the clinicaltrials.gov office but it’s worked in the past for some SKCCC trials): “The raw study data is no longer available for this study [or] the design of … Continue reading

Helpful Links


NIH Final Rule September 16, 2016 Federal Register Notice: HHS Final Rule Federal Register Vol. 81, No 183, September 21, 2016 Federal Register Notice: NIH Policy Summary Table: HHS Final Rule and NIH Policy Summary of Changes: HHS Final Rule and NIH Policy JAMA: Toward a New Era of Trust and Transparency in Clinical Trials NEJM: The Final Rule for US Clinical Trial Registration and Results Information Submission NIH Director’s Blog: Clinical Trials – Sharing of Data and Living Up to Our End of the Bargain NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information The links below provide additional … Continue reading

Submitting Basic Results


When to submit Basic Results? No later than 12 months after (Primary) Completion Date. Primary Completion Date FDAAA [Required by for records first released on or after December 1, 2012] Date that the final subject was examined or received an intervention for purposes of final data collection for the primary outcome, whether the trial concluded per protocol or was terminated. Must keep this field accurate in ClincalTrials.gov since it’s how NIH determines the timeliness of basic results reporting Study Completion Date Final date on which data was (or is expected to be) collected. Source: https://prsinfo.clinicaltrials.gov/definitions.html#PrimaryCompletionDate

Updating a Study in-Process


Updates must occur: RPs must update the record within 30 daysof a change to recruitment status or completion date Record Verification Date must be updated at least every 6 months, even if no changes to the study (for all studies not yet completed). Failure to update ClinicalTrials.gov info can result in penalties Need to update ends when the study is completed/terminated and results are entered, approved and posted

Registration Information


ICMJE requires trial registry at or before first patient enrollment as a condition for publication. Source: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html The Responsible Party (RP) for an Applicable Clinical Trial must submit required clinical trial information through the Protocol Registration and Reporting System (PRS) no later than 21 days after enrollment of the first participant. Source: https://www.clinicaltrials.gov/ct2/manage-recs/fdaaa –Per updated Policy 103.25 “Organization Policy on Registration of Clinical Trials” Johns Hopkins University (JHU) must be identified as the RP –Benefits of assigning JHU as the RP Careful review of potential issues based on our prior experiences Reduction in the number of comments you will need … Continue reading

Responsible Party


The Responsible Party (RP) for a clinical trial must register the trial and submit results information. An RP can be: The Sponsor of the clinical trial (as defined in 21 CFR 50.3) who initiates the study (i.e., “Johns Hopkins University”) The Principal Investigator (PI) The Sponsor-Investigator (the individual who both initiates and conducts the study) –Per updated Policy 103.25 “Organization Policy on Registration of Clinical Trials” Johns Hopkins University (JHU) must be identified as the RP –Benefits of assigning JHU as the RP Careful review of potential issues based on our prior experiences Reduction in the number of comments you will … Continue reading

Registering and Reporting


Why Register and Report? Commitment to research participants Scientific validity/transparency Ethical standards Responsible stewardship of federal funds Required by law (FDAAA) * NEW* Required for any clinical trial funded in full or in part by NIH Required by NCI Required for journal publication (ICMJE) Required for CMS Required by WHO Who is Responsible for Registering a Trial? The Responsible Party (RP) for a clinical trial must register the trial and submit results information. An RP can be: The Sponsor of the clinical trial (as defined in section 21 CFR 50.3) who initiates the study.  The Johns Hopkins PI should consult … Continue reading

Timeline


  Year Entity Event 1997 Congress 1st U.S. law to require trial registration (FDAMA) 2000 NIH Releases ClinicalTrials.gov website 2005 ICMJE Requires registration before enrollment 2006 WHO All clinical trials should be registered 2007 CMS PI must enroll qualifying clinical trials in ClinicalTrials.gov 2007 Congress Expanded registration, submission of results and adverse events, civil penalties (FDAAA) 2008 NIH Releases results database 2015 CMS Mandatory Reporting of Clinical Trial Number on Claims  

ClinicalTrials.gov Program


The ClinicalTrials.gov program assists investigators with: The ethical, scientific and legal reasons for clinical trials registration and reporting Which trials are required to be registered and the timelines Tips, tricks and helpful content to improve the process Up-to-date information on institutional and federal policies Direct effort upon request (billable/hr.) Resources: BioMed Central Publication (Supported by the ICTR detailing survey results of academic organizations) Mayo-Wilson E, Heyward J, Keyes A, Reynolds J, White S, Atri N, Alexander C, Omar A, Ford DE, on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee. Clinical trial registration and reporting: … Continue reading