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Committee Detail

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.


HHS - 29125 - National Cancer Institute Clinical Trials and Translational Research Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameNational Cancer Institute Clinical Trials and Translational Research Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number29125
Original Establishment Date11/20/1985Committee StatusChartered
Actual Termination Date Committee URLhttp://deainfo.nci.nih.gov/advisory/ctac/ctac.htm
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*33
Current Charter Date4/14/2020Designated Fed Officer Position Title*DIRECTOR, COORDINATING CENTER FOR CLINICAL TRIALS
Date Of Renewal Charter4/14/2022Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*SHEILA
Exempt From Renewal*NoDesignated Federal Officer Middle NameA.
Specific Termination AuthorityDesignated Federal Officer Last Name*PRINDIVILLE
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixMD, MPH
Specific Establishment Authority*42 USC 285a-2(b)(7)Designated Federal Officer Phone*240-276-6173
Effective Date Of Authority*11/20/1985Designated Federal Officer Fax*240-276-6274
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*prindivs@mail.nih.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The Committee is composed of scientific leaders and public members knowledgeable in the fields of community oncology, surgical oncology, medical oncology, radiation oncology, patient advocacy, extramural clinical investigation, regulatory agencies, pharmaceutical industry, public health, clinical trials design, management and evaluation, drug development and developmental therapeutics, cancer education, cancer information services, community outreach, vaccine development, cellular oncology, molecular oncology, pediatric oncology, clinical, basic and translational research, cancer center administration, cancer biology and diagnosis, cancer epidemiology, chemotherapy, oncology health care providers, pharmacology, pathology, biostatistics, quality of life, health care outcomes, pain management, cancer treatment and restorative care, and education of health professionals. The Committee provides advice to the NCI Director, NCI Deputy Directors, and the Director of each NCI Division on the NCI-supported national clinical trials enterprise to build a strong scientific infrastructure by bringing together a broadly developed and engaged coalition of stakeholders involved in the clinical trials process. In FY2020, the Committee met one time on March 12, 2020 (virtual meeting). The Committee’s discussion was focused on the Quantitative Imaging Network (QIN) Working Group’s report. The Committee deliberated on and approved the report. The Committee approved a motion to form the CTAC Ad Hoc Strategic Planning Working Group which will re-assess NCI’s strategic vision for its clinical trials system for 2030 and beyond. The CTAC meeting summary from the July 17, 2019 meeting was approved by the Committee members at their March 12, 2020 meeting.
How is membership balanced?*The Committee consists of up to 25 members. When necessary, five members will hold concurrent membership on either the National Cancer Advisory Board, Board of Scientific Advisors, Board of Scientific Counselors (Basic Sciences and Clinical Sciences and Epidemiology), or NCI Council of Research Advocates. Members are leaders knowledgeable in the fields of community oncology, surgical oncology, medical oncology, radiation oncology, patient advocacy, extramural clinical investigation, regulatory agencies, pharmaceutical industry, public health, clinical trials design, management and evaluation, drug development and developmental therapeutics, cancer education, cancer information services, community outreach, vaccine development, cellular oncology, molecular oncology, pediatric oncology, clinical, basic and translational research, cancer center administration, cancer biology and diagnosis, cancer epidemiology, chemotherapy, oncology health care providers, pharmacology, pathology, biostatistics, quality of life, health care outcomes, pain management, cancer treatment and restorative care, and education of health professionals.
How frequent & relevant are cmte mtgs?*The Committee meets approximately three times each fiscal year. In FY2020, the Committee met one time virtually on March 12, 2020. The Committee's deliberations are an indispensable part of the review of a very large clinical trials and translational research program. In addition to the CTAC parent meeting, the Ad Hoc Radiation Oncology Working Group met once on October 7, 2019; the Quantitative Imaging Network (QIN) Working Group met on November 15, 2019. Additionally, the Ad Hoc Strategic Planning Working Group met twice on November 6, 2019 and July 15, 2020.
Why advice can't be obtained elsewhere?*This Committee is composed of recognized biomedical research authorities from outside the NIH in order to secure unbiased and objective evaluations of clinical trials and translational research programs. Their recommendations are invaluable because the complex nature of the research requires a unique balance and breadth of expertise not available at NIH or from other established sources.
Why close or partially close meetings?N/A
Recommendation RemarksMembers: The terms for Timothy Eberlein, David Gershenson, Patrick Loehrer, Augusto Ochoa, Roman Perez-Soler, Gloria Petersen, and Dan Theodorescu have changed due to administrative extensions. Howard Fingert left the committee on 11/7/2019. Several Ex Officio members were reappointed (James Doroshow, William Dahut, Paulette Gray, Michael Kelley, Anthony Kerlavage, and Richard Pazdur). As such, their term of service end date is different than what was reported on the FY19 ACR. The term for Nancy Davidson is longer than the charter allows due to their reappointment to the CTAC given specific scientific expertise needed and to serve as both a member (4/22/2012 - 06/30/2015) and then as Chair (11/12/2015 - 07/31/2018) to assure continuity in the functions of the CTAC and the deliberation of issues brought before the Board. In December 2018, Nancy Davidson was appointed to the NCI Board of Scientific Counselors for Clinical Science and Epidemiology (BSC C&E) and will serve as a BSC C&E representative on CTAC until the end of her term in July 2022.

Meetings: The committee was unable to meet three times during the fiscal year due to agenda topic scheduling difficulties.

The DFO and Committee Decision Maker positions are held by the same individual because of the assignment of responsibilities within the Institute.

The working group report was deliberated on by the NCI Clinical Trials and Translational Research Advisory Committee.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentNoAction Reallocate ResourcesNo
Outcome Major Policy ChangesYesAction Issued New RegulationsNo
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionNoAction CommentThe committee makes recommendations to federal staff on the NCI-supported national clinical trials enterprise to build a strong scientific infrastructure by bringing together a broadly developed and engaged coalition of stakeholders involved in the clinical trials process. Based on the recommendations of this committee, NCI has restructured its clinical trials infrastructure to enhance efficiency and scientific quality, instituted policy changes, developed scientific frameworks for recalcitrant cancers, and constituted oversight working groups.
Outcome Implement Laws/Reg RequirementsNoGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentN/ANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentNIH-supported basic and clinical research accomplishments often take many years to unfold into new diagnostic tests and new ways to treat and prevent diseases.Grants Review CommentN/A
Number Of Recommendations*84Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentIn addition to some general recommendation the committee had the following specific recommendations: A motion to form the CTAC Strategic Planning Working Group, and A motion carried to accept the report of the Quantitative Imaging Network (QIN) Working Group with the modification recommended during this meeting.Access Agency WebsiteYes
% of Recs Fully Implemented*99.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe percentage of recommendations implemented stated above was developed at the time the Annual Comprehensive Review report was prepared. Additional information is available through the RePORT (Research Portfolio Online Reporting Tool) website. RePORT provides access to reports, data, and analyses of NIH research activities that advance the mission of the NIH, including information on NIH expenditures, strategic plans, reports on NIH funding, and reports on the organization and people involved in NIH research and research training. The RePORT website is located at http://report.nih.gov.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*1.00%Access PublicationsYes
% of Recs Partially Implemented CommentThe percentage of recommendations implemented stated above was developed at the time the Annual Comprehensive Review report was prepared. Additional information is available through the RePORT (Research Portfolio Online Reporting Tool) website. RePORT provides access to reports, data, and analyses of NIH research activities that advance the mission of the NIH, including information on NIH expenditures, strategic plans, reports on NIH funding, and reports on the organization and people involved in NIH research and research training. The RePORT website is located at http://report.nih.gov.Access OtherYes
Agency Feedback*YesAccess CommentInformation on CTAC can be found at the NCI Division of Extramural Activities: Advisory Boards, Committees and Review Groups website at http://deainfo.nci.nih.gov/advisory/ctac/ctac.htm. Each NCI committee’s charter, minutes, agenda, roster, future meeting dates, meeting Power Points and reports are located here. Additionally, the public may view the CTAC meetings (both live and on demand) via the NIH Videocast at the following website: http://videocast.nih.gov/.
Agency Feedback Comment*The agency provided feedback to the various NCI advisory boards with periodic updates at meetings.Narrative Description*The goal of the NIH research is to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability, from the rarest genetic disorder to the common cold. The NIH works toward that mission by utilizing the National Cancer Institute Clinical Trials and Translational Research Advisory Committee (CTAC). The CTAC conducts and provides oversight and implementation of clinical trials across the Institute. The Committee consists of up to 25 members. When necessary, five members will hold concurrent membership on either the National Cancer Advisory Board, Board of Scientific Advisors, Board of Scientific Counselors (Basic Sciences and Clinical Sciences and Epidemiology), or NCI Council of Research Advocates. Members will be authorities in the fields of community oncology, surgical oncology, medical oncology, radiation oncology, patient advocacy, extramural clinical investigation, regulatory agencies, pharmaceutical industry, public health, clinical trials design, management and evaluation, drug development and developmental therapeutics, cancer education, cancer information services, community outreach, vaccine development, cellular oncology, molecular oncology, pediatric oncology, clinical, basic and translational research, cancer center administration, cancer biology and diagnosis, cancer epidemiology, chemotherapy, oncology health care providers, pharmacology, pathology, biostatistics, quality of life, health care outcomes, pain management, cancer treatment and restorative care, and education of health professionals.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$10,800.00Est Payments to Non-Fed Members Next FY*$10,800.00
Payments to Federal Members*$3,274.00Est. Payments to Fed Members Next FY*$3,274.00
Payments to Federal Staff*$85,143.00Estimated Payments to Federal Staff*$80,623.00
Payments to Consultants*$6,200.00Est. Payments to Consultants Next FY*$6,200.00
Travel Reimb. For Non-Federal Members*$11,345.00Est Travel Reimb Non-Fed Members nextFY*$11,422.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$12,400.00Est Travel Reimb to Consultants Next FY*$12,475.00
Other Costs$2,647.00Est. Other Costs Next FY*$2,675.00
Total Costs$131,809.00Est. Total Next FY*$127,469.00
Federal Staff Support (FTE)*0.40Est. Fed Staff Support Next FY*0.40
Cost RemarksActual costs lower than projected in FY19. Only one meeting held and it was convened virtually instead of in-person in response to COVID-19 pandemic. Daily salary costs have been estimated for Ex Officio members of this committee. The dollar figure represents a portion of their annual salary. No additional funds are paid to Federal employees due to membership on this committee.Est Cost RemarksEstimated payments to Federal staff is lower than in FY20 because there were staffing and salary changes. This resulted in a slight decrease in the projected total federal staff costs.
Hide Section - Interest Areas

Interest Areas

Category
Area
Health
Treatment
Medicine
Diseases
Health and Health Research
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-036527National Cancer Institute Clinical Trials and Translational Research Advisory Committee2019
 COM-034735National Cancer Institute Clinical Trials and Translational Research Advisory Committee2018
 COM-001970National Cancer Institute Clinical Trials and Translational Research Advisory Committee2017
 COM-002651National Cancer Institute Clinical Trials and Translational Research Advisory Committee2016
 COM-004186National Cancer Institute Clinical Trials and Translational Research Advisory Committee2015
 COM-004446National Cancer Institute Clinical Trials and Translational Research Advisory Committee2014
 COM-006253National Cancer Institute Clinical Trials and Translational Research Advisory Committee2013
 COM-006518National Cancer Institute Clinical Trials and Translational Research Advisory Committee2012
 COM-008251National Cancer Institute Clinical Trials and Translational Research Advisory Committee2011
 COM-008809National Cancer Institute Clinical Trials and Translational Research Advisory Committee2010
 COM-010313National Cancer Institute Clinical Trials and Translational Research Advisory Committee2009
 COM-010667National Cancer Institute Clinical Trials Advisory Committee2008
 COM-011931National Cancer Institute Clinical Trials Advisory Committee2007
 COM-012653National Cancer Institute Clinical Trials Advisory Committee2006