Progress Report 6.30.11.xlsx - American Society of Clinical Oncology
Progress Report 6.30.11.xlsx - American Society of Clinical Oncology
Progress Report 6.30.11.xlsx - American Society of Clinical Oncology
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Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
Goal 1: Improve the speed and efficiency <strong>of</strong> the design, launch, and conduct <strong>of</strong> clinical trials (Page 4 and 10 <strong>of</strong> the IOM report)<br />
Recommendation 1: NCI should facilitate some consolidation <strong>of</strong> Cooperative Group front <strong>of</strong>fice operations by reviewing and ranking the Groups with defined metrics<br />
on a similar timetable and by linking funding to review scores (Page 16 <strong>of</strong> the IOM report)<br />
Key planning and scientific evaluations<br />
should be at the disease site committee<br />
level. The focus should be on the quality<br />
and success <strong>of</strong> the clinical trial concepts<br />
developed and the committee's record <strong>of</strong><br />
development <strong>of</strong> new investigators<br />
Committees that do well in review should<br />
be funded, and committees with low<br />
review scores should be eliminated<br />
Status <strong>Report</strong> <strong>of</strong> Implementation <strong>of</strong> IOM <strong>Report</strong> Recommendations<br />
Current as <strong>of</strong> June 2011<br />
The March 2011 IOM‐ASCO workshop assembled all the stakeholders in the Cooperative Group system to discuss the report’s recommendations and<br />
identify activities (taken or planned) in response to the IOM report on the cooperative groups. This document reflects ASCO’s summation <strong>of</strong> the<br />
information presented at the workshop and analysis <strong>of</strong> the progress to date in implementation <strong>of</strong> the IOM recommendations. The critical stakeholders in<br />
the system have outlined initial steps that could cause substantial and meaningful changes in the Cooperative Group system. ASCO issues this status<br />
report to document actions taken to date and outline areas where progress is still needed. ASCO will periodically issue updates to this report and<br />
continue to advocate and support implementation <strong>of</strong> all the report recommendations. In addition, ASCO is working with the IOM to plan a follow‐up<br />
workshop.<br />
ASCO welcomes feedback on this document. Please contact us at researchpolicy@asco.org with comments, questions, or additional information on<br />
stakeholder activities.<br />
Committees should be organized with a<br />
multidisciplinary focus on disease sites,<br />
and Group leaders should consolidate<br />
disease site committees from different<br />
Groups to strengthen their productivity<br />
and review scores<br />
NCI<br />
NCI: Announced planned development <strong>of</strong> funding<br />
opportunity announcement (FOA) for maximum <strong>of</strong><br />
four adult groups and one pediatric group to<br />
participate in National <strong>Clinical</strong> Trials Network. All<br />
groups would compete concurrently.<br />
Initiated: <strong>Progress</strong> will depend on final<br />
Cooperative Group guidelines, FOA language,<br />
and review criteria for Groups and disease<br />
committees. FOA concept planned for<br />
submission to Board <strong>of</strong> Scientific Advisors in<br />
November 2011.<br />
NCI [See above] [See above]<br />
Cooperative<br />
Groups<br />
Cooperative Groups: Publicly announced<br />
mergers/alliances include 1) CALGB, NCCTG and<br />
ACOSOG; 2) RTOG, GOG and NSABP; and 3) ECOG<br />
and ACRIN<br />
NCI: Announced that four adult groups would need<br />
to have "multi‐modality capacity"<br />
Page 1 <strong>of</strong> 14<br />
Initiated: <strong>Progress</strong> will depend on the details<br />
<strong>of</strong> the Group mergers/alliances. At this point,<br />
it is not clear whether they will result in<br />
consolidation <strong>of</strong> disease committees and<br />
multi‐disciplinary focus in all the Groups.
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
Recommendation 2: NCI should require and facilitate the consolidation <strong>of</strong> administration and data management operations across all <strong>of</strong> the Cooperative Groups (the<br />
back <strong>of</strong>fice operations) and, working with the extramural community, make process improvement in the operational and organizational management <strong>of</strong> clinical trials<br />
a priority (Page 17‐18 <strong>of</strong> the IOM report)<br />
NCI should facilitate the consolidation <strong>of</strong><br />
<strong>of</strong>fices and personnel for such activities as<br />
data collection and management, data<br />
queries and reviews to ensure that the<br />
data collected are complete and accurate,<br />
patient registration, audit functions,<br />
submission <strong>of</strong> case report forms, training<br />
<strong>of</strong> clinical research associates, image<br />
storage and retrieval, drug distribution,<br />
credentialing <strong>of</strong> sites, and funding and<br />
reimbursement for patient accrual<br />
NCI should work with governmental and<br />
nongovernmental agencies with relevant<br />
expertise to facilitate the identification <strong>of</strong><br />
best practices in the management <strong>of</strong><br />
clinical research logistics and develop,<br />
publish, and use performance, process,<br />
and timing standards and metrics to<br />
assess the efficiency and operational<br />
quality <strong>of</strong> clinical trials<br />
NCI<br />
Cooperative<br />
Groups<br />
NCI<br />
Cooperative<br />
Groups<br />
Non‐governmental<br />
Organizations<br />
NCI: Developing a single, electronic, clinical trials<br />
data management system (CDMS), starting in 2011.<br />
The full implementation <strong>of</strong> a common CDMS will<br />
include: establishment <strong>of</strong> standard procedures for<br />
data collection, development <strong>of</strong> electronic case<br />
report forms that use common data elements,<br />
implementation <strong>of</strong> a common electronic protocol<br />
authoring tool, development <strong>of</strong> a common Group<br />
credentialing system for investigators and sites, and<br />
standardization <strong>of</strong> key aspects <strong>of</strong> protocol<br />
development across the Group system; Centralized<br />
regulatory support for site participation in Group<br />
trials; Standardizing <strong>of</strong> other key procedures and<br />
processes for both operations as well as statistical<br />
and data management across the system; Created<br />
and enhanced the <strong>Clinical</strong> Trials <strong>Report</strong>ing Program<br />
for registering NCI‐supported trials on<br />
<strong>Clinical</strong>Trials.gov<br />
NCI & Cooperative Groups: NCI's implementation<br />
<strong>of</strong> the Operational Efficiency Working Group<br />
(OEWG) targets and deadlines for trial initiation are<br />
standards that the entire Program must use. NCI's<br />
online protocol monitoring tool also provides a<br />
resource for investigators to identify problems in<br />
the development and initiation once a concept has<br />
been submitted.<br />
Page 2 <strong>of</strong> 14<br />
Initiated in Part: <strong>Progress</strong> will depend on<br />
whether the CDMS includes all the elements<br />
that NCI envisions, as well as how the<br />
mergers/alliances evolve.<br />
Not Initiated Aspects: NCI and the Groups do<br />
not appear to be addressing<br />
recommendations for facilitation <strong>of</strong> common<br />
1) data queries and reviews; 2) audit<br />
functions; 3) training <strong>of</strong> CRAs; 4) system for<br />
image storage and retrieval; 5) credentialing<br />
<strong>of</strong> sites; and 6) system for funding and<br />
reimbursement for patient accrual.<br />
Initiated in Part: <strong>Progress</strong> will depend on<br />
ongoing efforts to “assess the efficiency and<br />
operational quality <strong>of</strong> clinical trials”
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
NCI should coordinate and streamline the<br />
protocol development process, as<br />
recommended by the Operational<br />
Efficiency Working Group<br />
NCI should devote more funds to drug<br />
distribution<br />
NCI should provide resources and<br />
technical assistance to facilitate the rapid<br />
adoption <strong>of</strong> a common patient<br />
registration system as well as a common<br />
remote data capture system<br />
NCI should facilitate more efficient and<br />
timely methods for ensuring that trial<br />
data are complete and accurate<br />
NCI should develop standardized case<br />
report forms that meet regulatory<br />
requirements<br />
All review bodies should distinguish<br />
between major review concerns<br />
(regarding patient safety and critical<br />
scientific flaws, which must be addressed)<br />
and minor concerns (which should be<br />
considered, but are not obligatory).<br />
NCI<br />
NCI: Implemented Operational Efficiency Working<br />
Group (OEWG) recommendations for tracking and<br />
metrics related to clinical trial development and<br />
activation;<br />
NCI Not Initiated<br />
NCI<br />
NCI<br />
NCI<br />
NCI<br />
FDA<br />
NCI: Centralized patient registration system via the<br />
<strong>Oncology</strong> Patient Enrollment Network (OPEN) under<br />
the Cancer Trials Support Unit (CTSU).<br />
NCI: Developing a single, electronic, clinical trials<br />
data management system (CDMS), starting in 2011.<br />
NCI: Developing a single, electronic, clinical trials<br />
data management system (CDMS), starting in 2011.<br />
The full implementation <strong>of</strong> a common CDMS will<br />
include development <strong>of</strong> electronic case report forms<br />
that use common data elements.<br />
NCI: Has committed to the provision <strong>of</strong> "feedback<br />
on major challenges" in 5 days during the concept<br />
review/revision process. It has also enhanced the<br />
speed and process to improve communications<br />
during the review process.<br />
Initiated: Early data shows that NCI, the<br />
Groups, and investigators are meeting target<br />
timelines. Further progress may depend on<br />
resources continuing to be available.<br />
Initiated: NCI has created the patient<br />
registration mechanism and is in the<br />
implementation process. The CDMS is in the<br />
early stages <strong>of</strong> development.<br />
Initiated: As the NCI envisions it, the CDMS<br />
could enable efficient and timely data<br />
collection. It is possible that the system could<br />
also enable methods to ensure completeness<br />
and accuracy <strong>of</strong> data.<br />
Initiated: <strong>Progress</strong> will depend on follow‐up<br />
with FDA and OHRP to ensure that forms<br />
meet regulatory requirements.<br />
Recommendation 3: The US Department <strong>of</strong> Health and Human Services should lead a trans‐agency effort to streamline and harmonize government oversight and<br />
regulation <strong>of</strong> cancer clinical trials (Page 19‐20 <strong>of</strong> the IOM report)<br />
Page 3 <strong>of</strong> 14<br />
Initiated in Part: <strong>Progress</strong> will depend on<br />
whether the improved process for<br />
communications also distinguishes between<br />
major and minor concerns.
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
NCI should coordinate with FDA for the<br />
review and oversight <strong>of</strong> trials involving an<br />
investigational new drug or<br />
investigational device exemption to<br />
eliminate iterative review steps.<br />
FDA should establish a coordinated<br />
Cancer Program across its centers that<br />
regulate oncology products.<br />
FDA should update its regulatory<br />
guidelines for the minimum data required<br />
to establish the safety and efficacy <strong>of</strong><br />
experimental therapies (including<br />
combinations <strong>of</strong> products) and eliminate<br />
requirements for nonessential data,<br />
particularly for supplemental new drug<br />
and biologic license applications.<br />
NCI<br />
FDA<br />
FDA<br />
FDA<br />
NCI: Working with CDRH/FDA to coordinate early<br />
review <strong>of</strong> investigational devices used in treatment<br />
trials (biomarker assays, genomic signatures).<br />
Developed coordinated protocol development &<br />
review processes with Groups for phase 3 trials<br />
developed under FDA Special Protocol Assessment<br />
(SPA). Established an interagency agreement with<br />
FDA for early review <strong>of</strong> approved Cooperative Group<br />
Phase 3 treatment trials that are identified as<br />
licensing trials. FDA review timelines specified as<br />
part <strong>of</strong> OEWG<br />
FDA: The Agency established the Office <strong>of</strong> <strong>Oncology</strong><br />
Drug Products (OODP) in 2005. According to FDA, “<br />
OODP oversees development, approval, and<br />
regulation <strong>of</strong>:<br />
• Drug treatments for cancer<br />
• Therapeutic biologic treatments for cancer<br />
• Therapies for prevention <strong>of</strong> cancer<br />
• Products for treatment <strong>of</strong> nonmalignant<br />
hematologic conditions”<br />
ASCO/NCI/CGs/Industry: Developed<br />
recommendations for an optimal dataset for<br />
supplemental applications.<br />
FDA: Issued a 2001 guidance document on data<br />
requirements in cases where extensive safety data<br />
exist. FDA also issued a draft guidance in December<br />
2010 addressing targeted drug combinations.<br />
Page 4 <strong>of</strong> 14<br />
Initiated in Part: NCI and FDA had these<br />
processes in place at the time <strong>of</strong> the IOM<br />
report (with the exception <strong>of</strong> the OEWG<br />
requirement). The IOM called for additional<br />
steps to improve NCI and FDA coordination<br />
because the agencies’ reviews continue to be<br />
separate and not harmonized. This leads to<br />
overlapping, duplicative, and additional<br />
reviews.<br />
Initiated in Part: While FDA does not appear<br />
to be moving toward a single organizational<br />
structure, the Office <strong>of</strong> <strong>Oncology</strong> Drug<br />
Products (OODP) ensures there are<br />
connections among the Centers when<br />
oncology product review is conducted<br />
outside <strong>of</strong> OODP.<br />
Not Initiated: The 2001 guidance has had<br />
little influence on the amount <strong>of</strong> data for<br />
supplemental applications. It is unclear if FDA<br />
intends to take additional steps or issue<br />
revised guidance on this topic.
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
OHRP: In March 2009, issued an advanced notice <strong>of</strong><br />
proposed rulemaking regarding OHRP enforcement<br />
authority <strong>of</strong> external institutional review boards<br />
The [Department <strong>of</strong> HHS] Office for<br />
Human Research Protections (OHRP)<br />
should develop guidance that clearly<br />
establishes the accountability <strong>of</strong> the NCI<br />
central institutional review board, to<br />
encourage its wider use and acceptance<br />
by local institutions.<br />
Federal oversight should be more flexible<br />
in allowing minor amendments to the<br />
protocol or consent form to fast‐track the<br />
chain <strong>of</strong> reapprovals.<br />
Patient consent forms should include a<br />
shortened and simplified summary to<br />
enhance the provision <strong>of</strong> informed<br />
consent.<br />
NCI should develop standard licensing<br />
language and contract templates for<br />
material and data transfer and for<br />
intellectual property ownership in<br />
biospecimen‐based studies and trials that<br />
combine intellectual property from<br />
multiple sources<br />
OHRP<br />
NCI<br />
IRBS<br />
FDA<br />
NCI<br />
OHRP<br />
NCI<br />
OHRP<br />
Cooperative<br />
Groups<br />
NCI<br />
(IRBs). OHRP has also issued letters and<br />
commentaries clarifying that central IRB review for<br />
multisite studies can meet regulatory requirements<br />
and is more effective, in some cases. At the March<br />
2011 IOM‐ASCO workshop on implementation <strong>of</strong><br />
the IOM report, the OHRP director mentioned that<br />
trial sponsors could require use <strong>of</strong> a central IRB.<br />
NCI: The CIRB review process has been streamlined,<br />
and NCI is exploring a pilot that would expand the<br />
role <strong>of</strong> the CIRB to be the "IRB <strong>of</strong> record."<br />
NCI: Currently engaged in process to make NCI<br />
template more concise.<br />
NCI: In collaboration with CEO Roundtable on<br />
Cancer, developed Standard Terms <strong>of</strong> Agreement<br />
for Research Trials (START) clauses for company<br />
and academic collaborations. Assessing the<br />
feasibility <strong>of</strong> developing standardized Material and<br />
Transfer Agreements (MTAs) that cover Intellectual<br />
Property (IP) considerations; Issued revised IP<br />
option on all CTEP Cooperative Research and<br />
Development Agreements relating to drug<br />
development and specimen/correlative sciences<br />
interactions<br />
Page 5 <strong>of</strong> 14<br />
Initiated in Part: OHRP is attempting to<br />
encourage use <strong>of</strong> central IRBs, but does not<br />
appear to be pursuing regulatory change or<br />
issuing clear guidance, at this time.<br />
Not Initiated<br />
Initiated in Part: <strong>Progress</strong> will depend on<br />
whether the NCI process results in a<br />
“shortened or simplified” summary, whether<br />
OHRP would support use <strong>of</strong> a summary, and<br />
whether the CIRB and local IRBs will permit<br />
use <strong>of</strong> the summary.<br />
Recommendation 4: NCI should take steps to facilitate more collaboration among the various stakeholders in cancer clinical trials (Page 22 <strong>of</strong> the IOM report)<br />
Complete: 1) Standard contract templates,<br />
although many institutions and industry do<br />
not appear to be using them as a starting<br />
point and 2) IP option revisions<br />
Initiated in Part: Feasibility analysis <strong>of</strong><br />
developing standardized MTAs
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
NCI should facilitate the creation <strong>of</strong> more<br />
public‐private partnerships and<br />
precompetitive consortia, guided in part<br />
by successful models<br />
NCI should facilitate the development <strong>of</strong><br />
appropriate hybrid funding models, in<br />
which NCI and industry support clearly<br />
defined components <strong>of</strong> trials that are <strong>of</strong><br />
mutual interest<br />
NCI should facilitate a process by which<br />
stakeholders (NCI, NIH, FDA, industry,<br />
investigators, and patients) can define an<br />
effective mechanism for the development<br />
<strong>of</strong> targeted cancer therapies, with<br />
particular emphasis on combinations <strong>of</strong><br />
products<br />
NCI should implement a highly visible<br />
grand challenge competition to engage<br />
experts in cancer and non‐cancer fields<br />
(e.g., engineering, social science,<br />
management, and marketing) and to<br />
reward significant innovation leading to<br />
increased efficiency in clinical trials<br />
processes<br />
NCI<br />
Industry<br />
NCI<br />
Cooperative<br />
Groups<br />
Industry<br />
NCI<br />
NIH<br />
FDA<br />
Industry<br />
Investigators<br />
Groups & Industry: Developing these kinds <strong>of</strong><br />
funding arrangements<br />
FDA: Issued draft guidance on 1) qualification<br />
process for drug development tools and 2) co‐<br />
development <strong>of</strong> two or more unmarketed<br />
investigational drugs for use in combination<br />
NCI & Cooperative Groups: Developing new<br />
processes to enhance collaboration among<br />
Cooperative Groups, NCI, and other stakeholders on<br />
trial development<br />
Other Stakeholders: There are potential<br />
opportunities for collaboration across NIH with the<br />
<strong>Clinical</strong> and Translational Science Award Program, as<br />
well as the FDA‐Duke <strong>Clinical</strong> Trials Transformation<br />
Initiative (CTTI).<br />
Not Initiated<br />
NCI Not Initiated<br />
Page 6 <strong>of</strong> 14<br />
Initiated in Part: by Groups and Industry<br />
Initiated in Part: <strong>Progress</strong> will depend on<br />
final guidance documents and whether they<br />
are used by the stakeholders, as well as<br />
whether stakeholders take advantage <strong>of</strong><br />
collaboration opportunities.
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
Goal 2: Incorporate innovative science and trial design into cancer clinical trials (Page 4 and 24 <strong>of</strong> the IOM report)<br />
Recommendation 5: NCI should mandate the submission <strong>of</strong> annotated biospecimens to high‐quality, standardized central biorepositories when samples are collected<br />
from patients in the course <strong>of</strong> Cooperative Group trials and should implement new funding mechanisms and policies to support the management and use <strong>of</strong> those<br />
resources for retrospective correlative science (Page 25 <strong>of</strong> the IOM report)<br />
All data, including biomarker data from<br />
serum, tissue, and imaging analyses<br />
should be considered precompetitive,<br />
unencumbered by intellectual property<br />
restrictions, and made widely available.<br />
The accompanying clinical data should be<br />
reported on standardized forms.<br />
NCI should establish a national inventory<br />
<strong>of</strong> samples held in the central repositories<br />
and have a defined process for access by<br />
researchers that includes a single<br />
scientific peer review linked to funding.<br />
NCI<br />
Cooperative<br />
Groups<br />
Industry<br />
NCI<br />
FDA<br />
NCI<br />
Cooperative<br />
Groups<br />
NCI: Developed policy to cover intellectual property<br />
issues related to biospecimen use and clinical trials<br />
for Collaborative Research and Development<br />
Agreements (CRADAs)<br />
NCI: Developing a single, electronic, clinical trials<br />
data management system (CDMS), starting in 2011.<br />
NCI: Developed U24 mechanism to support central<br />
biorepositories with common/centralized operating<br />
procedures for samples collected from patients in<br />
Cooperative Group trials;<br />
Working with the Cooperative Groups on<br />
consolidating biorepositories to create a public<br />
resource within a national banking system that<br />
supports NCI‐supported clinical trial networks<br />
Cooperative Groups: There are many examples <strong>of</strong><br />
biomarker‐driven Group trials. The Groups<br />
performed the first randomized discontinuation trial<br />
in oncology and phase II trials with adaptive designs<br />
are now being used more <strong>of</strong>ten in Group trials.<br />
NCI: Worked with the Investigational Drug Steering<br />
Committee (IDSC) on evaluation <strong>of</strong> innovative<br />
clinical trial designs as well as other key issues<br />
related to cancer therapeutics<br />
Initiated in Part: Unclear whether the IP<br />
policy will enable precompetitive work and<br />
whether it addresses imaging analyses<br />
Initiated in Part: Unclear whether<br />
common/centralized procedures will include<br />
clinical data<br />
Initiated in Part: Unclear whether<br />
consolidation will create national inventory<br />
and single scientific peer review<br />
Recommendation 6: Cooperative Groups should lead the development and assessment <strong>of</strong> innovative designs for clinical trials that evaluate cancer therapeutics and<br />
biomarkers, including combinations <strong>of</strong> therapies (Page 26 <strong>of</strong> the IOM report)<br />
Cooperative Groups should lead the<br />
development and assessment <strong>of</strong><br />
innovative designs for clinical trials that<br />
evaluate cancer therapeutics and<br />
biomarkers (including combinations <strong>of</strong><br />
therapies)<br />
Cooperative<br />
Groups<br />
NCI<br />
Page 7 <strong>of</strong> 14<br />
Initiated: Groups are beginning to use<br />
innovative designs and NCI’s IDSC evaluation<br />
may help promote their use. However, it is<br />
unclear at this point if the Groups are leading<br />
the development and assessment <strong>of</strong><br />
innovative designs.
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
Recommendation 7: NCI, in cooperation with other agencies, should establish a consistent, dynamic process to oversee the development <strong>of</strong> national unified<br />
standards as needed for oncology research (Page 27‐28 <strong>of</strong> the IOM report)<br />
This process should be used by NCI when<br />
standards are required for any important<br />
new technology, tool, or breakthrough<br />
method (e.g., biomedical imaging and<br />
other biomarkers and biospecimens)<br />
This process should replicate successful<br />
aspects <strong>of</strong> standards development by<br />
other standard‐setting bodies, both<br />
governmental and nongovernmental (e.g.,<br />
the <strong>American</strong> <strong>Society</strong> for Testing and<br />
Materials, the National Standards<br />
Foundation, the National Institute for<br />
Standards and Technology, the<br />
International Organization for<br />
Standardization, and pr<strong>of</strong>essional<br />
societies)<br />
This process should utilize the input <strong>of</strong><br />
experts in both subject matter and<br />
standards design in developing standards<br />
This process should include consistent<br />
operating procedures for developing<br />
standards (e.g., representation <strong>of</strong><br />
stakeholders in committee composition,<br />
decision making, and voting rules)<br />
NCI<br />
NCI: NCI instituted the Biomarker, Imaging and<br />
Quality <strong>of</strong> Life Studies Funding Program (BIQSFP) to<br />
ensure that critical biomarkers, imaging and quality<br />
<strong>of</strong> life studies for selected, prioritized clinical trials<br />
are incorporated into phase 3 and large, multi‐<br />
institutional phase 2 trials.<br />
NCI is now developing the <strong>Clinical</strong> Assay<br />
Development Program to provide standardized<br />
biomarker assays to investigators.<br />
NCI [See above]<br />
Initiated: NCI’s BIQSFP has established<br />
standards for description <strong>of</strong> integral<br />
biomarkers in clinical trials. It is unclear<br />
whether this will lead to a “consistent,<br />
dynamic process.”<br />
Initiated in Part: It is unclear whether NCI<br />
and the Groups are connecting with “other<br />
standard‐setting bodies.”<br />
NCI [See above] [See above]<br />
NCI [See above] [See above]<br />
Page 8 <strong>of</strong> 14
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
This process should publish and update<br />
the standards in a timely manner such<br />
that they are useful to those performing<br />
clinical trials<br />
NCI<br />
Journals<br />
NCI: The REMARK guidelines include information<br />
that should be reported in all publications about<br />
tumor markers.<br />
Goal 3: Improve prioritization, selection, support and completion <strong>of</strong> cancer clinical trials (Page 4 and 29 <strong>of</strong> the IOM report)<br />
Recommendation 8: NCI should reevaluate its role in the clinical trials system (Page 30‐31 <strong>of</strong> the IOM report)<br />
NCI should file more investigational new<br />
drug applications for agents to be tested<br />
in high‐priority trials and provide a<br />
leadership role to ensure the success <strong>of</strong><br />
those studies.<br />
In cases in which NCI does not hold the<br />
investigational new drug application, the<br />
primary focus <strong>of</strong> NCI should be on<br />
supporting high‐priority trials, with less<br />
emphasis on oversight <strong>of</strong> the selection<br />
and implementation process and greater<br />
focus on facilitating the launch and<br />
execution <strong>of</strong> the trial.<br />
The process <strong>of</strong> peer review for trial<br />
concepts should be strengthened and<br />
streamlined and should entail the<br />
evaluation <strong>of</strong> concise proposals (including<br />
the intended statistical design) that are<br />
ranked against each other. The emphasis<br />
should be on scientific strength and<br />
opportunity, innovation, feasibility, and<br />
the importance to improving patient<br />
outcomes.<br />
NCI<br />
Industry<br />
NCI: NCI Experimental Therapeutics Program<br />
(NexT) <strong>of</strong>fers a single pipeline to industrial partners<br />
and academic researchers who wish to partner with<br />
NCI in developing their treatment or diagnostic<br />
agents. It is hoped that this program will increase<br />
the number <strong>of</strong> IND agents in the NCI portfolio.<br />
NCI Not Initiated<br />
NCI<br />
Cooperative<br />
Groups<br />
NCI: Implemented disease‐ and modality‐specific<br />
steering committees. OEWG requirements place<br />
specific timelines on concept and protocol review.<br />
Proposal for new cross‐disease panel to develop<br />
priorities for the national clinical trials system.<br />
Convening <strong>Clinical</strong> Trials Planning meetings to<br />
identify critical clinical trial issues for future studies.<br />
Page 9 <strong>of</strong> 14<br />
Initiated: Relatively few journals require<br />
REMARK criteria. Those journals that do<br />
require do not consistently apply or enforce<br />
the criteria. <strong>Progress</strong> will depend on whether<br />
the guidelines are updated “in a timely<br />
manner.”<br />
Initiated in Part: <strong>Progress</strong> will depend on<br />
whether initiatives such as revised IP<br />
language and NexT will enable NCI to acquire<br />
more agents from industry for NCI‐supported<br />
trials<br />
Initiated in Part: It is unclear whether the<br />
steps taken are revising the review<br />
emphases.
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
Steering committees administered by NCI<br />
should operate independently <strong>of</strong> NCI staff<br />
and should focus on the prioritization <strong>of</strong><br />
clinical needs and scientific opportunities,<br />
selection <strong>of</strong> trial concepts proposed by<br />
the Cooperative Group disease site<br />
committees, and facilitation <strong>of</strong><br />
communication and cooperation among<br />
the Groups.<br />
NCI Not Initiated<br />
Recommendation 9: NCI, Cooperative Groups and physicians should take steps to increase the speed, volume and diversity <strong>of</strong> patient accrual and to ensure high‐<br />
quality performance at all sites participating in Cooperative Group trials (Page 32 <strong>of</strong> the IOM report)<br />
They should develop electronic tools that<br />
cue physicians practicing oncology via<br />
electronic medical record systems about<br />
trials for which a particular patient is<br />
eligible<br />
They should encourage patient eligibility<br />
criteria that allow the broadest<br />
participation possible<br />
They should encourage greater<br />
enrollment in high‐priority trials,<br />
regardless <strong>of</strong> where the trial originates<br />
They should establish a centralized<br />
credentialing system for participating<br />
sites<br />
They should eliminate investigators and<br />
sites with low rates <strong>of</strong> accrual or<br />
inadequate data management skills or<br />
quality<br />
Cooperative<br />
Groups<br />
NCI<br />
Investigators<br />
NCI<br />
Cooperative<br />
Groups<br />
NCI<br />
Cooperative<br />
Groups<br />
NCI<br />
Cooperative<br />
Groups<br />
NCI<br />
Cooperative<br />
Groups<br />
NCI: Proposal for revised Cooperative Group<br />
Program emphasizes national enrollment on trials,<br />
regardless <strong>of</strong> Group that originates trial<br />
Page 10 <strong>of</strong> 14<br />
Not Initiated<br />
Not Initiated<br />
Initiated: <strong>Progress</strong> will depend on final<br />
Cooperative Group guidelines, FOA language,<br />
and review criteria for Groups and disease<br />
committees<br />
Not Initiated<br />
Not Initiated
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
They should strive to make participation<br />
in clinical trials a key component <strong>of</strong><br />
clinical practice and to achieve the<br />
exemplary attributes <strong>of</strong> the <strong>American</strong><br />
<strong>Society</strong> <strong>of</strong> <strong>Clinical</strong> <strong>Oncology</strong> for academic<br />
and community clinical trial sites,<br />
including high accrual rates <strong>of</strong> 10 percent<br />
or more<br />
They should encourage greater<br />
participation <strong>of</strong> patient advocates in trial<br />
concept development and accrual<br />
planning, and partnerships with patient<br />
advocacy organizations to support accrual<br />
efforts<br />
NCI should increase the per case<br />
reimbursement rate and adequately fund<br />
highly ranked trials to cover the costs <strong>of</strong><br />
the trial, including the costs <strong>of</strong> biomedical<br />
imaging and other biomarker tests that<br />
are integral to the trial design.<br />
NCI<br />
Cooperative<br />
Groups<br />
ASCO<br />
Cooperative<br />
Groups<br />
NCI<br />
NCI<br />
NCI NCCCP Sites: Some are working to implement<br />
the exemplary attributes.<br />
ASCO and Conquer Cancer Foundation: 1) Series in<br />
Journal <strong>of</strong> <strong>Oncology</strong> Practice provides practical<br />
information for implementing exemplary attributes,<br />
2) Community <strong>Oncology</strong> Research Grant provides<br />
funding for sites to implement exemplary attributes,<br />
and 3) <strong>Clinical</strong> Trials Participation Award recognizes<br />
high quality research sites.<br />
NCI and Groups: Advocates included in NCI Disease<br />
Steering Committees and Cooperative Groups<br />
NCI & ASCO: Hosted Cancer Trial Accrual<br />
Symposium (2010) that involved patient advocates<br />
and focused on science <strong>of</strong> patient accrual, successful<br />
strategies and ways to improve planning<br />
Recommendation 10: NCI should allocate a larger portion <strong>of</strong> its research portfolio to the <strong>Clinical</strong> Trials Cooperative Group Program to ensure that the Program has<br />
sufficient resources to achieve its unique mission (Page 34 <strong>of</strong> the IOM report)<br />
NCI: NCI has developed targeted initiatives to try<br />
to increase reimbursement: 1) phase 2 studies from<br />
$2000 to $5000 per case; 2) additional funding<br />
beyond the standard $2,000 per patient for selected<br />
phase 3 trials based on their complexity and 3)<br />
instituted the Biomarker, Imaging and Quality <strong>of</strong><br />
Life Studies Funding Program (BIQSFP) to ensure<br />
that critical biomarkers, imaging and quality <strong>of</strong> life<br />
studies for selected, prioritized clinical trials are<br />
incorporated into phase 3 Cooperative Group trials<br />
and large, multi‐institutional phase 2 Group<br />
treatment trials<br />
Page 11 <strong>of</strong> 14<br />
Initiated in Part: Implementation by NCCCP<br />
sites and ASCO/CCF sites are limited at this<br />
point. More sites may be trying to achieve<br />
the standards, but no formal assessment has<br />
been conducted.<br />
Initiated in Part: <strong>Progress</strong> will depend on the<br />
incorporation <strong>of</strong> advocates in the newly<br />
structured National <strong>Clinical</strong> Trials Networks<br />
and in the Group mergers/alliances.<br />
Initiated in Part: NCI efforts to date are<br />
limited in their reach and amount <strong>of</strong> funding<br />
increases.
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
To ensure sufficient funding for high‐<br />
priority trials, the total number <strong>of</strong> NCI‐<br />
funded trials undertaken by the<br />
Cooperative Groups should be reduced to<br />
a quantity that can be adequately<br />
supported.<br />
External advisory boards, such as the<br />
National Cancer Advisory Board and the<br />
Board <strong>of</strong> Scientific Advisors, should have<br />
greater roles in advising NCI on how it<br />
allocates its funds to support a national<br />
clinical trials program.<br />
NCI<br />
NCI<br />
NCAB<br />
BSA<br />
NCI: Proposal envisions a comprehensive approach<br />
to both funding as well as shared strategic<br />
management to maximize resources and enhance<br />
collaboration<br />
NCI: While the BSA will be involved in review <strong>of</strong><br />
revised FOA and NCAB will review the new Group<br />
applications, the boards are not involved in<br />
decisions <strong>of</strong> how to allocate funding.<br />
Goal 4: Incentivize the participation <strong>of</strong> patients and physicians in clinical trials (Page 4 and 35 <strong>of</strong> the IOM <strong>Report</strong>)<br />
NCI should provide funding to site and<br />
trial principal investigators to cover the<br />
time that they need to develop and<br />
oversee approved trials.<br />
NCI<br />
NCI: Working across divisions to harmonize<br />
guidelines for clinical trial programs to provide<br />
appropriate incentives for collaboration<br />
NCI, Cooperative Groups, & Cancer Centers: NCI<br />
has hosted two meetings between cancer center<br />
directors and Group Chairs to discuss how to better<br />
align incentives and promote collaboration.<br />
NCI: Created a <strong>Clinical</strong> Investigator Team<br />
Leadership Award to promote collaborative science<br />
and recognize outstanding clinical investigators (11<br />
in 2009 and 12 in 2010)<br />
Not Initiated<br />
Not Initiated<br />
Recommendation 11: All stakeholders, including academic medical centers, community practices, pr<strong>of</strong>essional societies and NCI, should work to ensure that clinical<br />
investigators have adequate training and mentoring, paid protected research time, the necessary resources and recognition (Page 36 <strong>of</strong> the IOM report)<br />
NCI should recognize and reward<br />
Cooperative Group efforts in Cancer<br />
Center Support Grant (CCSG; P30) site<br />
visits, and allow the CCSG research base<br />
to include the federal per case funding<br />
received by cancer centers that<br />
participate in Cooperative Group trials.<br />
NCI<br />
Cooperative<br />
Groups<br />
Cancer Centers<br />
Page 12 <strong>of</strong> 14<br />
Initiated: <strong>Progress</strong> will depend on final<br />
implementation <strong>of</strong> the cancer center and<br />
National <strong>Clinical</strong> Trials Network guidelines.<br />
Initiated: NCI efforts to date are limited in<br />
their reach and funding
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
Academic medical centers should develop<br />
policies and evaluation metrics that<br />
recognize and reward clinical and team<br />
research in promotion and tenure<br />
decisions.<br />
NCI should work with a nonpr<strong>of</strong>it<br />
foundation to develop a certification<br />
program and registry, as recommended<br />
by the <strong>Clinical</strong> Trials Working Group.<br />
The Centers for Medicare & Medicaid<br />
Services (via a national coverage<br />
decision), federal and state health<br />
benefits plans, and private health insurers<br />
should establish consistent payment<br />
policies to cover all patient care costs<br />
(except for study‐related costs, such as<br />
study drugs, devices, and tests, which<br />
should be paid for by the manufacturer)<br />
in clinical trials approved through the NCI<br />
prioritization mechanism, without having<br />
to pay for experimental therapies<br />
administered to patients outside <strong>of</strong> a<br />
clinical trial (any such limitation in<br />
coverage should not affect <strong>of</strong>f‐label use<br />
that is backed by evidence from clinical<br />
trials published in the scientific literature,<br />
as evidence‐based <strong>of</strong>f‐label use<br />
constitutes the standard <strong>of</strong> care for many<br />
cancer therapies and is therefore not<br />
experimental)<br />
Academic Medical<br />
Centers<br />
Pr<strong>of</strong>essional Societies: AACI released report in 2010<br />
detailing measures taken by various cancer centers<br />
across America to increase recruitment and<br />
retention <strong>of</strong> clinical investigators (see:<br />
http://www.aaci‐<br />
cancer.org/oncologyworkforce.asp).<br />
NCI Not Initiated<br />
CMS<br />
Private Insurers<br />
CMS & NCI: In 2005, worked to establish pilot<br />
program for reimbursement for clinical trials care<br />
under a CMS national coverage decision for agents<br />
used for colorectal cancer as well as on data<br />
collection to evaluate use <strong>of</strong> imaging and other<br />
clinical modalities. Initial data from NCI and CMS<br />
showed that studies in the pilot had higher accrual<br />
<strong>of</strong> Medicare‐aged trial participants.<br />
Initiated in Part: AACI report details the<br />
efforts that some cancer centers have made.<br />
Recommendation 12: Health care payment policies should value the care provided to patients in clinical trials and adequately compensate that care (Page 37‐38 <strong>of</strong><br />
the IOM report)<br />
Page 13 <strong>of</strong> 14<br />
Initiated in Part: Medicare, as well as some<br />
private payers, cover routine care in clinical<br />
trials. However, the policies are not<br />
consistent across Medicare, federal statute<br />
(which goes into effect in 2014), and state<br />
law. CMS and NCI have not continued the<br />
pilot collaborative.
Specific Recommendations Stakeholder(s) Actions Taken by Stakeholders <strong>Progress</strong> Evaluated<br />
The <strong>American</strong> Medical Association should<br />
establish new Current Procedural<br />
Terminology codes, reimbursed by the<br />
Centers for Medicare & Medicaid<br />
Services, private insurers, and other third‐<br />
party payers, to pay an enhanced<br />
reimbursement for <strong>of</strong>fering, enrolling,<br />
managing, and following a patient in a<br />
clinical trial.<br />
The U.S. Congress should amend the<br />
Employee Retirement Income Security Act<br />
<strong>of</strong> 1974 to prohibit health plans from<br />
denying (or from limiting or imposing<br />
additional conditions on) coverage for the<br />
routine care associated with clinical trial<br />
participation.<br />
AMA<br />
CMS<br />
Private Insurers<br />
Congress<br />
Congress: Passed Affordable Care Act in 2010 that<br />
includes a provision to require coverage <strong>of</strong> clinical<br />
trials, effective in 2014<br />
NCI: Participation with NIH and across HHS to help<br />
shape national policy on clinical trials<br />
reimbursement and to educate patients and payors<br />
regarding the benefit <strong>of</strong> clinical trials<br />
Page 14 <strong>of</strong> 14<br />
Not Initiated<br />
Initiated: Statute is enacted. Implementation<br />
regulations need to be developed.