Clinical Trials Reporting Program (CTRP) and Clinicaltrials.gov (CT.gov) Helpful tips and guidance

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1 Clinical Trials Reporting Program (CTRP) and Clinicaltrials.gov (CT.gov) Helpful tips and guidance

2 Objectives

3 NCI s Clinical Trials Reporting Program (CTRP) Overview

4 CTRP What is it? CTRP is an NCI mandated comprehensive protocol registration database of regularly updated information on all NCI-supported clinical trials. The database was created due to the initiative of the Clinical Trials Working Group (CTWG) Report It was created to help identify gaps and duplicative studies in clinical research and to facilitate prioritization of clinical trials for the NCI Any NCI-supported interventional trials opened to accrual as of or after January 1, 2009 requires registration Cancer Centers were able to apply for supplemental funding to help fund a CTRP Coordinator position

5 CTRP What is it? NCI-supported means all trials sponsored or otherwise financially supported by the NCI. This means that all interventional clinical trials conducted at NCI-designated Cancer Centers must be registered no matter who the sponsor is including Investigator- Initiated and industry sponsored trials Exceptions to this rule are studies that are reviewed and monitored by NCI CTEP, DCP PIOs, and NCI CCR. These trials are not required to be registered via the CTRP registration site by the designated Cancer Centers

6 What does this mean for the UWCCC? For our purposes, all interventional trials (therapeutic, supportive care, and prevention) as well as Screening, Detection, and Early Diagnostic studies that are considered IITs will be required to be registered via CTRP Who is responsible for the registration? Your UWCCC CTRP Coordinator!

7 What does the CTRP Coordinator do? The CTRP Coordinator performs the initial registration of required trials into the CTRP Registration database The coordinator is also responsible for all updates to trials once registered including submission of major amendments, status updates, participating site information, and accrual

8 What information is required for registration into CTRP? Minimum information required for registration: Protocol Number Protocol Title Trial Type Phase Current Trial Status and Date this includes anticipated completion dates Lead Organization PI NIH Grant information if applicable Responsible Party Regulatory Information See CT.GOV/CTRP tab in the Main Tab of the PC Console in OnCore Trial Related Documents Protocol Participating Site List IRB Approval Document OR Memo of Pending IRB Approval when registration occurs pre-approval

9 What happens when a study is registered? Once a study has been registered, the NCI CTRO staff extracts the information from the protocol and registration page and plugs it into a Trial Summary Report (TSR) The TSR is sent to the CTRP Coordinator for review to ensure accuracy Once reviewed, the coordinator accepts the TSR (or submits revisions) and the study is considered registered in CTRP

10 What exactly is a Trial Summary Report (TSR)? A summary of the information found in the protocol This summary is equivalent to the information that has to be uploaded into ClinicalTrials.gov (CT.gov) As we ll discuss later, the TSR is what allows the CTRP coordinator to upload the CT.gov submissions at the click of a button. A few minor tweaks are done to the record in CT.gov to ensure that the sponsor and organization information are listed correctly. This is why it is important that the groups fill in the required information in the CT.gov/CTRP tab and the Study Completion Dates in OnCore which will also be discussed later in the presentation

11 National Institutes of Health (NIH) ClinicalTrials.gov (CT.gov) Overview

12 CT.gov What is it? CT.gov, originally developed in 2000, is a mandated public access protocol registration database originally developed by the NIH in collaboration with the Food and Drug Administration (FDA) The FDA Amendment Act (FDAAA) added additional requirements for CT.gov including results reporting in September 2007

13 CT.gov What is it? The Food and Drug Administration (FDA) requires study registration (along with results and adverse event reporting) for Phase II - IV interventional drug, biologic or device trials ("applicable clinical trials")

14 What is an applicable clinical trial? Trials of drugs and biologics that are subject to FDA regulation Trials of devices which provide health outcomes subject to FDA regulation and which require pediatric postmarket surveillance This generally includes interventional studies of FDA regulated drugs, biologics, or devices that meet one of the following: Trial has one or more sites in US Trial is conducted under an FDA IND or IDE Trial involves a drug, biologic, or device manufactured in the US and is exported for research

15 What types of trials are excluded? Per FDAAA 801 the following are excluded: Phase I* drug trials Trials where the primary outcome measures feasibility and not health outcomes Trials not including drugs, biologics, or devices Non-interventional trials such as cohort or casecontrol studies Trials ongoing as of 9/27/2007 but reached completion before 12/26/2007 *Please note it is best practice, regardless of phase to register all interventional trials per the ICMJE requirements which will be discussed

16 Who requires registration? FDA - within 20 days of first patient accrued ICMJE - before 1 st patient accrued Center for Medicare & Medicaid Services (CMS) requires the registration of most studies billing third parties for study related services- UW Health Research Billing Compliance Program requires an NCT # (CT.gov registration number) before trial can be approved

17 International Committee of Medical Journal Editors (ICMJE) ICMJE recommends that all medical journal editors require registration of clinical trials in a public registry Trials must be registered at or before the time of the first patient enrollment for consideration of publication ICMJE defines a clinical trial as any research project that prospectively assigns people/groups of people to an intervention to study the relationship between a health intervention and health outcome Much bigger scope than CT.gov for registration

18 What does ICMJE have to do with UWCCC? Some trials that are considered interventional IITs by our standards may not necessarily be required per FDAAA guidelines to be registered to CT.gov however for publishing purposes they must be registered This means it is best to err on the side of caution and register the trial as stated on the ICMJE website Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal

19 Why comply with Registration? Failing to register or report results for "applicable clinical trials" in a timely manner can result in significant monetary penalties imposed by the FDA Failure to register ( before the first patient accrued) may result in a rejection of a publication by ICMJE

20 CT.gov Results Reporting

21 What about Results Reporting? Per the FDAAA 801 requirements, the Responsible Parties must submit scientific and administrative information about trial results into CT.gov within a year of study completion Submitting results is similar to preparing a manuscript for publication Individuals familiar with the study design and data analysis (such and the PI or statistician) must be involved in order to accurately summarize the information

22 Results Reporting: Brief Overview Scientific information is submitted as four separate modules: Participant Flow Baseline Characteristics Outcome Measures & Statistical Analyses Adverse Events These modules display information in a series of data tables

23 Results Reporting Participant Flow A table...,including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any. The module should account for all enrolled participants, and should inform the interpretation of study outcomes by interpretation of study outcomes by illustrating which participants were analyzed

24 Results Reporting Baseline Characteristics A table of the demographic and baseline data collected overall and for each arm of the clinical trial Number of participants Age Gender Race Ethnicity Region of enrollment Entered for each Arm

25 Results Reporting Outcome Measures & Statistical Analyses a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial including the results of scientifically appropriate tests of the statistical significance of such outcome measures.

26 Results Reporting Adverse Events A table of anticipated and unanticipated serious adverse events grouped by organ system, with number and frequency of such event in each arm of the clinical trial.

27 Results Reporting: Miscellaneous Many helpful templates for results reporting can be found at Results reporting MUST be done by the research staff who have worked closely with the protocol the investigator and the statistician MUST be involved in the process it is the investigator s responsibility

28 Bringing it all together

29 What happens after registration to CT.gov? Once the study has been accepted, the CTRP coordinator enters the NCT number into OnCore and tells the DOWG the trial has been registered. Trial ownership is transferred back to the DOWG in order to allow the group to be able to make the timely updates and amendments as required Why back to the DOWG? Amendment information, status changes, etc. must be entered manually, therefore someone who has intimate knowledge of the protocol requiring updates must be the one responsible to ensure key points are updated appropriately

30 Why tie CTRP and CT.gov together? Both databases require registration of interventional trials and utilize similar information CTRP talks to CT.gov this is how we are able to centralize protocol registration for the Cancer Center into CT.gov By utilizing the CTRP registration process, the steps for registering trials to CT.gov became much less complicated and can be handled by a central person instead of each DOWG having to manually register trials

31 What does this mean for the UWCCC? Centralizing CT.gov registration frees up time for the DOWGs and PIs It falls into the workflow that coincides with CTRP registration Central registration helps to meet the new Center for Medicare & Medicaid (CMS) requirements having the NCT number in OnCore before IRB Approval

32 How will this impact workflows? DOWGs may need to change workflows to enter the following fields in OnCore by PRMC Approval for studies requiring CT.gov registration: Enter the Completion Dates in PC Console Main Details Tab under Completion Dates. Follow the OnCore DFDs for instructions. Fill out the CT.Gov/CTRP Tab in PC Console Main CT.GOV/CTRP. Follow the OnCore DFDs for instructions. DOWGs must also contact the CTRP Coordinator via once a qualifying trial has been PRMC approved and attach the protocol to the . This is a back-up verification to ensure that no qualifying protocols would miss a deadline for registration

33 How are trials registered in CT.gov via CTRP? The CTRP Coordinator registers trials with CTRP at PRMC approval pending IRB approval. NCI CTRO Staff extract information from the protocol to provide the TSR The coordinator reviews the TSR and either approves the TSR or submits changes Once the TSR has been approved the trial can be automatically uploaded to CT.gov via CTRP

34

35 CTRP and CT.gov - What does the future hold? Although it may seem like the work can be duplicative both registries were created for different reasons and are managed by separate entities CTRP is working towards working with cancer centers to simplify Summary 4 reporting

36 QUESTIONS?

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