Supporting Statement A For:
The Clinical Trials Reporting Program (CTRP) Database (NCI)
June 5, 2009
Submitted by:
Center for Biomedical Informatics and Information Technology
John Speakman
Office of the Director
National Cancer Institute
2115 East Jefferson Street
Rockville, MD 20852
Telephone: 301-451-8786
Fax:
E-mail: [email protected]
Table of Contents
A. Justification 1
A.1 Circumstances Making the Collection of Information Necessary 1
A.2. Purpose and Use of the Information 5
A.3 Use of Improved Information Technology and Burden Reduction 8
A.4 Efforts to Identify Duplication and Use of Similar Information 10
A.5 Impact on Small Businesses or Other Small Entities 12
A.6 Consequences of Collecting the Information Less Frequently 12
A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 13
A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 13
A.9 Explanation of Any Payment or Gift to Respondents 13
A.10 Assurance of Confidentiality Provided to Respondents 14
A.11 Justification for Sensitive Questions 15
A.12 Estimates of Annualized Burden Hours And Costs 15
A.13 Estimates of Other Total Annual Cost Burden to Respondents and
Record Keepers 16
A.14 Annualized Cost to the Federal Government 16
A.15 Explanation for Program Changes or Adjustments 16
A.16 Plans for Tabulation and Publication and Project Time Schedule 16
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate 18
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions 18
List of Attachments
Attachment 1 – NCI Clinical Trials Working Group Report
Attachment 2 – NCI CTRP Workflow and Screen Shots
Attachment 2A – NCI CTRP Registration Portal Workflow and Screen Shots
Attachment 2B – NCI CTRP Amendment Portal Workflow and Screen Shots
Attachment 3 – Clinical Trials Registration Program (CTRP) User’s Guide
Attachment 3A - CTRP Quick Start Guide
Attachment 3B – NCI CTRP Registration Site User’s Guide, v. 2.0
Attachment 4 – Consultations with NCI Advisory Boards and Organizations Outside NCI
Attachment 4A – NCI Advisory Boards
Attachment 4B –Organizations Outside NCI
Attachment 5 - Memo from NIH Privacy Act Officer
Attachment 6 – NIH OHSR Statement of Exemption
A.1 Circumstances Making the Collection of Information Necessary
In 2005, the National Cancer Advisory Board (NCAB), the federal advisory committee that advises the National Cancer Institute (NCI) on the national cancer program, approved the recommendation of its Clinical Trials Working Group (CTWG) to consolidate reporting, aggregate information and reduce redundant submissions. The NCAB also charged NCI program staff with implementing this recommendation. Subsequent reports to the NCI Clinical Trials Operating Committee (CTROC), the group within NCI responsible for implementing the CTWG recommendations, indicate that the agency’s current approach to clinical trials reporting prevents NCI from fully executing its mission. In effect, advances in information technology have rendered obsolete NCI’s current framework for complying with its statutory data collection and dissemination obligations.
As a consequence, the NCI is developing an electronic resource, the NCI Clinical Trials Reporting Program (CTRP) Database, which is designed to contain comprehensive, up-to-date information about all clinical research supported by the NCI. The resource is intended to serve as a single, definitive source of information about all NCI-supported clinical research, thereby enabling the NCI to execute its mission to reduce the burden of cancer and to ensure an optimal return on the nation’s investment in cancer clinical research.
NCI is charged by the National Cancer Act, 42 USC § 285, with managing the Nation’s cancer program. Specifically, NCI is required to:
Collect, analyze and disseminate all data useful in the prevention, diagnosis, and treatment of cancer, including the establishment of an international cancer research data bank to collect, catalog, store, and disseminate insofar as feasible the results of cancer research undertaken in any country for the use of any person involved in cancer research in any country. Stated in Section 407(a)(4) of the Public Health Service Act (codified at 42 USC § 285a-2(a)(2)(D); expanded in National Cancer Amendments of 1974 and the Health Research Extension Act of 1985 consolidated cancer communication activities and highlighted the International Cancer Research Data Bank.
Take necessary action to ensure that all channels for the dissemination and exchange of scientific knowledge and information are maintained between the National Cancer Institute and the other scientific, medical and biomedical disciplines and organizations nationally and internationally. Stated in Section 410(8) of the Public Health Service Act, codified at 42 USC § 285a-2(a)(1).
Prepare in consultation with the National Cancer Advisory Board and submit to the President for transmittal to the Congress a report on the activities, progress, and accomplishments under the National Cancer Program during the preceding calendar year and a plan for the Program during the next five years. Stated in Section 410A(b) of the Public Health Service Act, codified at 42 USC § 285a-4(b).
Deployment and extension of the CTRP Database is an infrastructure development project that will be enabled by public funds expended pursuant to the American Recovery and Reinvestment Act of 2009, P.L. 111-5 (“Recovery Act”). The Recovery Act presents the NCI with a unique opportunity to invest in significant expansions to its efforts to modernize the existing cancer clinical trials reporting infrastructure, which was previously instantiated through the NCI’s PDQ/Cancer.gov clinical trials submission portal. These investments will vastly improve the agency’s ability to conduct the nation’s cancer research program and comply with its statutory information collection obligations while substantially reducing the reporting burden of the NCI-supported clinical research community.
NCI’s role as the sponsor of a large number of cancer clinical trials implemented across a wide range of venues uniquely positions the Institute to take a global view of emerging knowledge about the effectiveness of cancer therapies, and to identify and disseminate important patterns and insights in a timely way. Furthermore, these patterns and insights can be fed quickly back into NCI’s program planning and prioritization activities to better identify global patterns in cancer trials as well as other diseases occurring in these large populations and avoid the inefficiency that results from duplication of clinical trials (e.g., two trials on broadly the same agent and condition being conducted simultaneously) and/or clinical trials conducted out of sequence (e.g., a Phase II trial being initiated after a Phase III trial of the same agent/condition has already begun)
The establishment of the CTRP Database was approved by the National Cancer Advisory Board (NCAB) in June 2005 following the report and recommendations of its Clinical Trials Working Group (CTWG) (See Attachment 1). The CTWG report envisioned an enhanced cancer clinical trials enterprise in which increased participation by the extramural community in the prioritization process more effectively focuses resources on those trials judged most likely to facilitate advances in treatment. As indicated in the CTWG report, the NCI does not currently have this management capability, which has notably led to redundant trial sponsorship and funded trials without patients. The current state of reporting, the reporting process and supporting systems do not allow the NCI to effectively manage the nation’s investment in cancer research.
The rapid pace of scientific progress has created an ever-increasing number of novel therapies to test. Only through an open, collaborative prioritization system involving all the critical stakeholders can the best decisions be made as to which agents and disease targets warrant an investment of taxpayer dollars in clinical trials.
Building a national clinical trials enterprise founded on the best science requires a new level of coordination and cooperation by ensuring that comprehensive information on cancer clinical trials is readily available for all stakeholders. This in turn will enhance scientific quality and prioritization so that NCI supports the best-designed trials, addressing the most important questions, leveraging the most significant scientific advances. It will also enhance standardization of tools and procedures for trial design, data capture, data sharing, and administrative functions to decrease effort and minimize duplication.
Because of its role as the sponsor of a large number of cancer clinical trials implemented across a wide range of venues, NCI is uniquely positioned to take a global view of emerging knowledge from cancer trials, and to identify important patterns and insights in a timely way. Routine review of safety, efficacy, and administrative data reported from ongoing NCI-funded clinical trials is essential to the timely recognition and appropriate dissemination of emerging insights on the safety and efficacy of new treatments, while also assuring that NCI’s resources are invested productively, and that its program planning and prioritization activities are based on the best and most recent available data. At present, this review of incoming data is constrained both by the absence of comprehensive data reporting and by limited capacity to evaluate such data critically. To assure an optimal return on the nation’s investment in cancer clinical trials, it is imperative not only that the completeness of data reporting be assured, but that sufficient capacity to monitor incoming data from all sponsored trials be present.
Fundamental to the success of this strengthened clinical trials prioritization process is access to comprehensive, up-to-date information about the status of cancer clinical trials. Accordingly, one of the CTWG report’s recommendations was the creation of an electronic database that would afford the following benefits:
When preparing new trial concepts and proposals, investigators can take into account other trials already completed or underway addressing similar questions, and thus eliminate unnecessary duplication of effort.
Clinical trial prioritization is enhanced by having available a full picture of the cancer clinical trials enterprise.
Patient accrual to trials is enhanced because physicians and patients are aware of relevant opportunities for participation in clinical trials.
Potential patient harm is reduced because toxicity and adverse events that are recognized in active trials can be rapidly disseminated to other investigators and practicing clinicians.
Patients benefit because patterns of favorable outcomes that are recognized in active trials can be rapidly disseminated to the clinical trials community.
A.2 Purpose and Use of the Information
The CTRP Database will provide a comprehensive real-time view of the state of NCI-funded cancer clinical trials, which will enable NCI to make informed prioritization decisions via disease-specific steering committees. Accordingly, this resource will allow the NCI to:
Manage its portfolio of cancer clinical research investments effectively;
Consolidate and streamline existing reporting to individual programs within the NCI by aggregating the information already collected and eliminating the need for redundant submissions to the NCI;
Comply with regulatory reporting requirements when acting as the sponsor of FDA-regulated clinical investigations;
Prepare the detailed performance, financial management and administrative accountability reports required of Executive Branch agencies, including those required by Executive Orders or OMB Circulars, Memoranda and Guidelines; and
Provide appropriate public access to cancer research information.
Additional benefits include:
The reporting burden for grantees will become increasingly streamlined.
Investigators will be aware of trials addressing similar questions that are already completed or in process to avoid duplication of efforts.
Researchers will have a comprehensive view of the clinical research enterprise that will support the cancer research community's ability to prioritize efforts.
In order to achieve these objectives, the resource must contain information that is structured to facilitate comparison across trials and that complies with Federal guidelines related to health information standards. The information must be detailed enough to fully describe the rich portfolio of clinical research supported by NCI and updated in a regular, timely fashion so that effective, real-time decision making can be made. Further, in order to assess the performance of the NCI’s research portfolio, the resource needs up-to-date information on accrual and outcomes, collected at an individual level without direct identifiers. For effective decision-making, the database will need to contain information for every clinical research activity supported either directly through grants for a specific project, or indirectly through grant support for technical or administrative infrastructure. More specifically, the resource will need to contain complete, standards-based, structured information on development phase, type of intervention or treatment, study design, and program through which funding is provided. The database must contain information concerning all clinical interventional and observational research conducted at institutions that receive NCI funding, including NCI Cooperative Group trials, externally peer-reviewed trials, institutionally supported investigator-initiated trials, and industry-sponsored studies.
Commencing with OMB approval of this submission, NCI will begin the first phase of information collection through the CTRP Database. After pilot activities are concluded (see Table A.16-1 below), all NCI-funded institutions conducting cancer clinical research will be expected to submit information to register trials in the CTRP Database. Submissions should include the trial protocol document, the template informed consent document, and IRB approval documentation, if available, and the following data elements relating to trial registration:
Lead organization
Lead organization trial identifier
NCT number
Principal investigator
Protocol title
Trial type
Trial phase
Trial purpose
Sponsor
Responsible party’s work email address
Responsible party’s work phone number
Summary 4 funding type
Summary 4 funding sponsor
NIH grant funding mechanism
NIH institute code
Serial number
NCI division/program code
Current trial status
Current trial status date
Trial start date (actual or anticipated)
Primary completion date (actual or anticipated)
IND/IDE number
IND/IDE grantor
IND/IDE holder type
Expanded access type (if applicable)
The NCI Clinical Trials Reporting Office (CTRO), a new unit formed in the Office of the NCI Director to support the NCI’s Clinical Trials Reporting Program, will extract additional information from submitted documents, including information describing any limitations on data use or limitations that may affect the submission or affect re-disclosures. Awardees will be responsible for reviewing any documents governing the conduct of study or use or disclosure of information collected during the study (e.g., informed consent documents, clinical trial agreements, material transfer agreements, and other sponsored funding or resource sharing agreements) and notifying NCI of any restrictions that could affect NCI’s use or disclosure of the submitted information. With respect to trials subject to proprietary restrictions, awardees will only be expected to submit the protocol title, the name of the principal investigator, and the sponsor though additional information may be submitted voluntarily. In some instances, certain entities funded by NCI may be expected to submit additional information as compared to previous reporting patterns.
Although OMB approval pursuant to the Paperwork Reduction Act is currently requested only for information collections pertaining to clinical trial registration, NCI intends shortly to extend the CTRP Database to enable submissions of data relating to study subject accrual information, and in the following year, to expand further to cover results reporting. These extensions to the CTRP Database have not yet been defined but NCI intends that they will be harmonized with the results reporting requirements of the Food and Drug Administration Amendments Act of 2007, P.L. 110-85 (FDAAA). NCI will update this Paperwork Reduction Act submission prior to expansion of the CTRP Database to include data elements that are specified in connection with these subsequent development activities.
The portions of the NCI CTRP Database that pertain to the description of clinical research projects and summarized information on accrual will be publicly accessible. This availability will facilitate the cancer community’s development of research proposals by providing up-to-date information on the existing portfolio of research activities, reducing duplication of effort by accessing a full picture of the cancer clinical research enterprise. Patient accrual and recruitment will be enhanced through better physician/patient access to clinical research data. All nonpublic parts of the resource will be maintained confidentially in accordance with appropriate security access controls pursuant to applicable policies.
Development of the NCI CTRP Database is managed by the NCI Center for Biomedical Informatics and Information Technology (CBIIT) under its cancer Biomedical Informatics Grid (caBIG®) program; it is therefore built on a state-of-the-art information technology platform using a shareable, common semantic services-oriented architecture and compliant with current biomedical data standards such as HL7® Version 3 and CDISC®. A current Privacy Impact Assessment (PIA) is in place for this IT System. The IT system name is, “NIH NCI Clinical Trials Reporting Program (CTRP).” A revised PIA is currently being processed due to the inclusion of personally identifiable information (see Section A.11).
The CTRP Database receives electronic data feeds from existing NCI systems to the extent available, thereby reducing the reporting burden. The data received from these systems represent the vast majority of trial registrations and accruals in the NCI-supported clinical research enterprise. For the remaining trials, the CTRP Database will support three methods for registration and reporting:
Online registration (see Attachment 2A) and amendment (see Attachment 2B) of individual trials via the CTRP web portal (see Attachments 3A & 3B)
Batch registration of multiple trials, uploadable directly to the CTRP Database via a Microsoft Excel file
Direct connection of site systems to NCI Enterprise Services for seamless near-real-time update of the CTRP Database (to be available in the near future)
NCI’s statutory collection obligations under the National Cancer Act, as well as its objective to consolidate existing reporting to individual programs within the NCI, aggregate the information already collected by these programs and eliminate the need for redundant submissions to the NCI, were major considerations in establishing this system. The CTRP Database has been designed so that as much as possible of the burden is shouldered by the staff of the NCI CTRO rather than by the respondent. In brief, the registration process is as follows:
The respondent registers the trial with the NCI Clinical Trials Portal (see Attachments 2A and 3A & 3B) by entering the data elements identified above in Section A.2 and uploading the protocol document file. The system sends an electronic notification to staff at the CTRO that the protocol has been registered.
CTRO staff members perform quality control (QC) on the registration submission and then abstract the remaining protocol elements used by the CTRP Database. Other CTRO staff members perform quality assurance (QA) on a sample of abstracted data.
The system generates a “trial summary report”, detailing the data that have been abstracted, and sends it via e-mail to the respondent for review. The coding letter e-mail message includes a “verification link” on which the respondent can click to either:
a. approve the data as correct, or
b. query, or request change, to abstracted data.
The Clinical Trials Working Group conducted a comprehensive review of current systems managing protocol information at the NCI. Due to initial scope, purpose, and data structure, it was determined that a new comprehensive system was necessary to accommodate the evolving NCI clinical trials enterprise. Existing systems were determined to be inappropriate for the purpose of pan-NCI trial prioritization, management and monitoring. Accordingly, the NCAB approved the establishment of an electronic resource to address these needs.
The data requested for submission to the NCI CTRP Database overlaps to some extent with the information NCI awardees must report to the NIH ClinicalTrials.Gov database if they are Responsible Parties under FDAAA. However, it is important to note that the goals and functionality of the CTRP Database are much broader than those pertaining to NIH ClinicalTrials.Gov. While both databases serve a public information dissemination function, the CTRP Database, which serves to modernize the existing cancer clinical trials reporting infrastructure previously instantiated through the NCI’s PDQ/Cancer.gov clinical trials submission portal, is also designed as an operational database for active, efficient and ongoing prioritization and management of cancer clinical trials. The CTRP Database’s greater breadth of purpose than ClinicalTrials.Gov thus leads to fairly divergent approaches. For example, in terms of data elements, several key concepts, such as objectives and structured eligibility criteria, are not included in the ClinicalTrials.Gov specifications.
In addition, the CTRP Database allows the specification of data elements of interest within conditions (e.g., in cancer clinical stage, histological type, grade of tumor), or qualifiers (e.g., again using cancer as an example, “unresectable”, “localized”, “recurrent”) that are not covered by ClinicalTrials.Gov. With respect to timing of collection, the CTRP Database enables investigators to update current data elements quarterly nearly in real-time rather than waiting until two years after study closure as is the case with ClinicalTrials.Gov. Real-time submission by NCI grantees of accrual, outcome and adverse event data directly into the CTRP Database is critical if NCI is to be able to perform this kind of portfolio management. The delays built into ClinicalTrials.Gov for the submission of accruals and results, while sensible for ClinicalTrials.Gov, are fundamentally inadequate for the NCI’s objectives. Further, as the data elements relating to outcomes are finalized, NCI expects the scope of information to be solicited to be much broader and more detailed, given the role of the CTRP Database in terms of facilitating NCI's portfolio management responsibilities.
Although there is some overlap between ClinicalTrials.Gov and the CTRP Database, ClinicalTrials.Gov is not sufficient for NCI's purposes either in terms of frequency or scope of reporting. Redesigning the CTRP Database such that we remove the overlapping elements and pull such data from ClinicalTrials.Gov into the CTRP Database will impede the NCI’s objective for this electronic resource and unduly burden NCI grantees, especially since many of the expanded ClinicalTrials.Gov elements have as yet to be worked out.
Nonetheless, NCI is committed to lessening the reporting burdens for its awardees. Accordingly, NCI has incorporated the data elements of FDAAA as well as those of other NCI reporting programs into CTRP to provide a “one-stop shop” for its awardees. To make submission as easy as possible for NCI awardees that are Responsible Parties under FDAAA, the CTRP Database automatically generates, as a by-product of CTRP registration, trial summary files (in XML format) that are compatible with the requirements of ClinicalTrials.gov, as described on the ClinicalTrials.Gov website (http://prsinfo.clinicaltrials.gov/definitions.html; http://prsinfo.clinicaltrials.gov/faq.html). After independently reviewing the trial summaries, NCI awardees can then choose to upload the XML files directly to ClinicalTrials.gov in lieu of registering their trials by manual entry through ClinicalTrials.gov's registration system. The XML files will be prepared by the NCI CTRO, which will extract the FDAAA-required data from the information provided to the CTRO through the NCI CTRP website portal. NCI will provide this service to reduce the effort of reporting to both NIH ClinicalTrials.Gov and the NCI CTRP Database.
Of course, responsibility for submitting any reports to ClinicalTrials.Gov in order to comply with FDAAA reporting requirements remains with the responsible party as defined by FDAAA. Submitting information to the CTRP Database does not replace or substitute for the requirement to comply with clinical trial reporting obligations pursuant to FDAAA. However, as noted above, an NCI awardee that submits data through the CTRP Database may determine to provide the XML files received from the NCI CTRO to ClinicalTrials.Gov. In that circumstance, the NCI awardee will be responsible for validating the information received from the NCI CTRO and submitting its reports directly to the NIH ClinicalTrials.Gov database.
The vast majority of data collection for clinical trials will involve NCI-designated Cancer Centers or other major medical centers. A small number of physicians in small practices conduct trials within the context of NCI Cooperative Groups.
The initial registration of the protocol is a one-time event. However, consistent with regulatory and reporting requirements, updates to protocol/study information are accepted every time there is an amendment - a major scientific change requiring approval by the site’s Institutional Review Board approval (IRB). Not collecting amendments will greatly compromise NCI’s ability to prioritize and monitor the system.
No special circumstances are anticipated.
Office of Management and Budget waived the publication of the 60-Day Federal Register notice due to the emergency clearance request. A 30-Day Federal Register notice was published around June 15, 2009.
In addition, NCI has previously solicited and received public input from many sources, including direct input from NCI Advisory Boards and research organizations supported by the NCI, both of which include patient advocates (See Attachments 4A and 4B). In addition, the informational website for the NCI Clinical Trials Reporting Program provides a mechanism for ongoing and routine electronic communications with the public (http://www.cancer.gov/clinicaltrials/ctrp/page9.)
No gifts will be given to respondents, nor any such expectations set. However, in order to mitigate the burden associated with adjusting to this new reporting mechanism, the NCI intends to offer participating NCI-designated Cancer Centers administrative grant supplements for a minimum of 12 months. Other awardees are not expected to have significant costs during the first year of operation and therefore will be encouraged to estimate reporting costs in connection with submission of grant and contract proposals to the NCI.
A.10 Assurance of Confidentiality Provided to Respondents
All records in the possession or control of the NIH are subject to the Freedom of Information Act (FOIA), 5 U.S.C. §552, and must be released in response to a FOIA request unless NIH determines that the record is exempt from release under one of the FOIA’s exemptions. Generally, NIH will seek to protect any information that if released would result in an unwarranted invasion of personal privacy as protected by FOIA Exemption 6, 5 USC §552(b)(6), including information that would identify a study subject or information that would lead to identification. If NIH receives a request for information that we believe contains information that may be exempt from release under FOIA Exemption 4, 5 USC §552(b)(4), we will give the submitter of the information an opportunity to demonstrate how release of the requested information could reasonably be expected to cause the submitter substantial competitive harm. NIH will give consideration to any such submission before making a determination on whether the information should be released. Since FOIA affords requesters an opportunity to contest an agency’s determination, NCI grantees subject to this policy will be advised that records that are determined by NIH to be exempt could subsequently be required to be released in response to FOIA requests.
No personally identifiable information is to be sent to the CTRP Database and the NIH Privacy Act Officer has determined that the Privacy Act does not apply to this information collection (see Attachment 5). This information collection has also been reviewed by NIH Office of Human Subjects Research (see Attachment 6).
A.11 Justification for Sensitive Questions
No questions of a sensitive nature are included in this data collection.
The annualized burden for CTRP registration and amendments is estimated to require 33,000 hours (see Table A.12-1). A total number of 570 small, medium and large institutions are anticipated to complete the initial registration and amendments during the year. At these institutions, a varying number of clinical investigator designees will submit this information. As a result of the difficulty in estimating the number of designees submitting information per institution, it is more reasonable to account for the burden based on a per-trial basis. It is estimated that there will approximately 500 trials submitted from small entities and 5000 trials submitted from the medium to large institutions; this amounts to a total of 5,500 trials. This burden estimate is very conservative because it assumes that no respondent will take advantage of the electronic batch upload features of the CTRP Database. As the NCI gains more experience with the program, it will be able to revise the burden estimate to reflect more accurately the actual time required for record-keeping.
A.12 - 1 Estimates of Annual Burden Hours |
|||||
Type of Respondents |
Survey Instrument |
Number of Respondents |
Frequency of Response |
Average Time per Response (Hours) |
Annual Burden Hours |
Clinical Trials |
Initial Registration |
5,500 |
1 |
2.0
|
11,000 |
Amendment |
5,500 |
4 |
1.0 |
22,000 |
|
Total |
|
|
33,000 |
||
A.12 - 2 Annualized Cost to Respondents
|
||||
Type of Respondents |
Survey Instrument |
Annual Burden Hours |
Hourly Wage Rate |
Respondent Cost |
Clinical Trials |
Initial Registration |
11,000 |
$35 |
$385,000 |
Amendments |
22,000 |
$35 |
$770,000 |
|
Totals |
|
33,000 |
$35 |
$1,155,000 |
The operating budget for the CTRP Database in FY2010 is approximately $4.2 million, which includes NCI staff salaries, overheads and equipment. Additional costs will be entailed in operating the database when it is expanded to include results reporting due to the increased volume of information to be processed. Such costs are expected to be on the order of $2 million per year for the first two or three years of operation.
This is a new collection of information with emergency processing. Deployment and extension of the CTRP Database is an infrastructure development project to be conducted pursuant to the American Recovery and Reinvestment Act.
As noted in Section A.1, the 2005 report of the Clinical Trials Working Group envisioned an enhanced cancer clinical trials enterprise in which increased participation by the extramural community in the prioritization process more effectively focuses resources on those trials judged most likely to facilitate advances in treatment. The Clinical Trials Reporting Program is thus the information platform for this prioritization process. In the four years since the publication of the report, NCI has established the infrastructure for providing the process, by establishing an Investigational Drug Steering Committee and multiple Disease-Specific Steering Committees, all of which operate under the aegis of NCI’s Clinical Trials Advisory Committee (CTAC), a federally approved advisory committee overseeing the implementation of all 22 recommendations of the Clinical Trials Working Group. The lack of availability of data from the CTRP Database is the single critical roadblock to NCI being able to use this infrastructure to effectively prioritize the nation’s investment in cancer research. Accordingly, NCI needs to deploy this resource as fast as possible while minimizing disruption to the active conduct of clinical trials within the NCI-supported clinical research enterprise. In order to enable this, the CTRP Database will be deployed in phases. The proposed time schedule for implementation of CTRP is shown in Table A.16-1.
Table A.16-1: Implementation Time Schedule |
||
Activity |
Start Date after OMB Approval |
Completion Date after OMB Approval |
Pilot Testing of CTRP Database |
|
|
Registration of New Trials |
|
|
Early Adopters |
Immediately |
4.5 months |
Registration of Existing Trials |
|
|
Early Adopters |
3 months |
12 months |
Production Deployment of CTRP Database |
|
|
Registration of New Trials |
|
|
All NCI-designated Cancer Centers |
4.5 months |
Ongoing |
Other NCI awardees |
7.5 months |
Ongoing |
Registration of Existing Trials |
|
|
All NCI-designated Cancer Centers |
7.5 months |
13.5 months |
Other NCI awardees |
10.5 months |
16.5 months |
Access to data in the NCI CTRP Database will be provided as follows:
Access for NCI program and administrative staff (in order to provide reports as needed for NCI’s prioritization infrastructure): Full access to the data within the CTRP Database will be provided to designated, appropriate NCI employee and contractor staff for purposes of portfolio management and compliance with regulatory and administrative reporting obligations. Access will be limited to those with a direct need to access the data. Access will be granted to non-Federal staff under a non-disclosure agreement and staff will be given mandatory privacy and security training.
Public access: Consistent with FDAAA requirements and timelines, open access to protocol registration information and summary level patient accrual and outcomes information will be provided to all persons not described above, including NCI intramural researchers.
Access for submitters: Individual submitters will have full access to information they have submitted; institutions of individual submitters will have access to tools that gather and present the accumulated data submitted by their individual investigators. Some cancer centers have indicated to NCI that the CTRP Database will be useful to them in order for them to manage their own clinical research portfolios.
All instruments will display the OMB expiration date.
No exceptions to the Certification for Paperwork Reduction Act Submissions are requested.
| File Type | application/msword |
| File Title | PLCO SCREENING TRIAL |
| Author | Linda Suit |
| File Modified | 2009-06-26 |
| File Created | 2009-06-26 |