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					                                                                                                                CTSU, Issue 12




Inside this issue:
Note from the      1
                        CTSU Newsletter
CTSU Project
Director
                        Note from the CTSU Project Director                                                By Steve RIORDAN

                                         Keeping with the pattern of reporting the view from my office, the fall colors are rap-
OPEN Updates       1
                                         idly disappearing, but there are some dogwoods with beautiful red leaves and some
                                         poplars that are as yellow as a candle flame. Soon all will be gray in mid-Maryland,
CTSU Accrual       2                     so I’ll enjoy the colors while they last.
Summary
                                          I thought it might be helpful to expand on the reporting of enrollments a little. The
Protocol Browser
                                          enrollment graph (see page 2), which has often been included in the newsletters now
                   2
Tree Expansion                            has a slightly different format. We have added lines to include all of the enrollments
                                          we do for all trials. Previously, we reported only the “CTSU enrollments,” meaning
Just Opened on the 3   those cross-group, non-lead group accruals to CTSU trials that come through the CTSU. However,
CTSU Menu              there are studies where we conduct enrollments on behalf of a lead Group, or for sites belonging to a
                       lead Group. One example is N0147, NCCTG member sites enroll to this study through the CTSU even
Site Suspensions   4   though they are members of the Lead Group. Another example is some ACOSOG studies that are not on
                       the CTSU menu, but for which we handle the enrollments and data management on behalf of ACOSOG.
PACCT1 Updates     5   While these additional enrollments are generally not processed for reimbursements, they do represent an
                       additional work load for us. I point this out because this is increasingly a service we provide, but one
ASCO Workshop      5
Presentation
                       which will be fully assumed by the implementation of the OPEN (Oncology Patient Enrollment Net-
                       work) system. With OPEN, the long-term goal is centralized registration of patient enrollments on Co-
New Study-Specific 6
                       operative Group trials, but in a fully automated way. We are working closely with NSABP and ECOG,
Training Tool          who will be the early adopters of OPEN, to implement this for the first protocols.
                       Another new development for the CTSU is our collaboration with the Children’s Oncology Group
Survey Results     6   (COG). We have been planning this for some time, but now are actively working to fold the COG into
                       the regulatory support services we provide to all Cooperative Groups. COG will also become users of
Top Enrolling
Investigators      7   the OPEN system and will eventually have some trials on the CTSU menu. Working with additional
                       study sponsors is increasingly becoming part of the services we provide. Look for more information on
Trial Complexity
                       the CTSU/COG collaboration in future newsletter issues.
                   8
Payments               An important article to note is the one on Trial Complexity payments, which will begin late this month
                       or early next month. In short, the NCI is providing an additional $ 1,000, or 0.5 credits for CCOP sites,
N0147 Payments     9   per enrollment to a select cohort of trials. Please see the article on page 8 for more information.
                       Until the next edition, thanks for your participation in the CTSU.


OPEN Updates                                                                                     By Lucille PATRICHUK

Despite some delays, Oncology Patient Enrollment Network so that Group members could have the opportunity to see first-
(OPEN) progress continues. The CTSU hopes to have OPEN hand how OPEN works. Look for the OPEN presentations and
in production for site use early next year.                 demos at the RTOG and GOG Group meetings in January,
                                                            2009!
In the meantime, the CTSU continues to introduce OPEN at
Cooperative Group meetings. CTSU staff attended the ECOG, By the end of the year, the OPEN training video and Site User
CALGB and NCCTG Cooperative Group meetings this past Guide will be available via the OPEN tab on the CTSU
summer and fall, where they presented OPEN to CRA audi- members’ web site. Updates will be posted on the CTSU
ences. The CTSU also provided demonstrations of the system, members’ web site on OPEN activation for sites.



     Page 1               Feedback?                             E-mail: CTSUContact@westat.com
                          Comments?                             Phone: 1-888-823-5923
                          Contact Us!
              CTSU, Issue 12
              CTSU, Issue 12                                                                            November 2008


CTSU Accrual Summary
                                                 CTSU Accrual Summary
                                                 Through October 31, 2008




The Protocol Browser Tree is Blossoming                                                              By Elias MAZUR

The protocol browser tree on the protocol page of the CTSU web site has “grown” a new branch: By Study Type. This
branch allows members to browse CTSU protocols by their study type. The current study types are:
•   Cancer Control
•   Cancer Treatment
•   Non-Therapeutic (e.g. specimen banking; epidemiology; QOL)
•   Phase 2 Consortia (restricted access)
•   Phase II
Since the majority of the protocols on the CTSU menu are Cancer Treatment
trials, protocols under this study type are further grouped by lead organization.
Cancer control trials are sponsored by the NCI’s Division of Cancer Prevention.
An increasing number of cancer control trials are under development for the
CTSU menu and will be the focus of an article in the next edition of the CTSU
Newsletter.
Phase 2 Consortia protocols have an additional layer of security and will only be available to members of institutions
that are authorized to participate. CTSU members without appropriate privileges will not be able to view the protocol
documents for these trials.


    Page 2
              CTSU, Issue 12                                                                              November 2008



Just Opened on the CTSU Menu                                                                      By Lena MUWAKKI

Protocol #: ACOSOG-Z6051                                       Protocol #: N0723
Protocol Title: A Phase III Prospective Randomized Trial       Protocol Title: MARVEL: Marker Validation of Erlotinib in
Comparing Laparoscopic-assisted Resection Versus Open          Lung Cancer - A Phase III Biomarker Validation Study of
Resection for Rectal Cancer                                    Second-Line Therapy in Patients With Advanced Non-Small
Accrual Target: 480                                            Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Ver-
Endorsing Groups: None                                         sus Erlotinib
ACOSOG Activation Date: 8/15/08                                Accrual Target: 957
CTSU Activation Date: 8/22/08                                  Endorsing Groups: CALGB, ECOG, NCIC CTG
                                                               NCCTG Activation Date: 10/01/08
Protocol #: CALGB-30607                                        CTSU Activation Date: 10/01/08
Protocol Title: Randomized, Phase III, Placebo-Controlled
Trial of Sunitinib as Maintenance Therapy in Non-Progressing   Protocol #: N0733
Patients Following an Initial Four Cycles of Platinum-Based    Protocol Title: Randomized Phase II Trial of Capecitabine
Combination Chemotherapy in Advanced, Stage IIIB/IV Non-       and Lapatinib with or without IMC-A12 in Patients with
Small Cell Lung Cancer                                         HER2 Positive Breast Cancer Previously Treated with Trastu-
Accrual Target: 156                                            zumab and an Anthracycline and/or a Taxane
Endorsing Groups: None                                         Accrual Target: 154
CALGB Activation Date: 6/15/08                                 Endorsing Groups: SWOG
CTSU Activation Date: 6/23/08                                  NCCTG Activation Date: 7/30/08
                                                               CTSU Activation Date: 7/30/08
Protocol #: CALGB-40502
Protocol Title: A Randomized Phase III Trial of Weekly         Protocol #: NSABP B-43
Paclitaxel Compared to Weekly Nanoparticle Albumin Bound       Protocol Title: A Phase III Clinical Trial Comparing Trastu-
(Nab)-Paclitaxel or Ixabepilone Combined with Bevacizumab      zumab Given Concurrently with Radiation Therapy and
as First or Second-Line Therapy for Locally Recurrent or Me-   Radiation Therapy Alone for Women with HER2-Positive
tastatic Breast Cancer.                                        Ductal Carcinoma in Situ Resected by Lumpectomy
Accrual Target: 900                                            Accrual Target: 2000
Endorsing Groups: NCCTG                                        Endorsing Groups: None
CALGB Activation Date: 10/13/08                                NSABP Pre-Activation Date: 11/7/08
CTSU Activation Date: 10/22/08                                 CTSU Pre-Activation Date: 11/7/08

Protocol #: E1305                                              Protocol #: S0535
Protocol Title: A Phase III Randomized Trial of Cisplatin      Protocol Title: A Phase II Study of ATRA, Arsenic Trioxide
and Docetaxel with or without Bevacizumab In Patients with     and Gemtuzumab Ozogamicin in Patients With Previously
Recurrent or Metastatic Head and Neck Cancer                   Untreated High-Risk Acute Promyelocytic Leukemia
Accrual Target: 400                                            Accrual Target: 70
Endorsing Groups: None                                         Endorsing Groups: CALGB, ECOG
ECOG Activation Date: 8/08/08                                  SWOG Activation Date: 11/15/07
CTSU Activation Date: 8/22/08                                  CTSU Activation Date: 6/23/08

Protocol #: E1697                                              Protocol #: WFU-07-02-03
Protocol Title: Phase III Randomized Study of Four Weeks       Protocol Title: A Randomized, Double-Blind, Placebo
High Dose IFN-A2B in Stage T2B NO, T3A-B NO, T4A-B             Controlled Trial of North American Ginseng Extract (CVT-
NO, and T1-4, N1A, 2A, 3 (microscopic) Melanoma                E002; COLD-fX) to Prevent Respiratory Infection and Re-
Accrual Target: 1420                                           duce Antibiotic Use in Patients with Chronic Lymphocytic
Endorsing Groups: SWOG                                         Leukemia
ECOG Activation Date: 12/22/98                                 Accrual Target: 336
CTSU Activation Date: 10/02/08                                 Endorsing Groups: N/A
                                                               CTSU Activation Date: 9/22/08
                                                               Please Note: This Trial Has a Very Short Enrollment
                                                               Period (November 1st through December 31st, 2008)!


    Page 3
               CTSU, Issue 12                                                                                  November 2008


Performance-Related Site Suspensions                                                                      By Martha HERING

If you were a guest at a friend’s house would you walk             acts as the Data Management Center. The CTSU also pro-
across their floors with muddy shoes or leave wet towels on        vides information on people designated as protocol-level
the floor? Of course not, so why would you participate on          DMs to the Groups via the reports available in RSS.
another Group’s study and not submit data, respond to que-
                                                                   Data Quality and Timeliness
ries, or even provide contact information to the sponsoring
                                                                   In addition to sanctioning sites that fail to maintain contact
Group? The scenarios are different but the concept is the
                                                                   information, sites that fail to maintain the data quality
same. Participating on another Groups’ study through the
                                                                   standards outlined by the protocol lead Group may be
CTSU is like being a houseguest of that Group, and their
                                                                   suspended from further enrollments to that Group’s studies
rules for study participation should be followed. These
                                                                   or to selected studies. The CTSU already provides lead
rules include maintaining accurate site contact information
                                                                   Groups a mechanism to suspend patient enrollment to a
and submitting data in a quality and timely manner.
                                                                   single study, but by the end of the year we will be
Contact Information                                                expanding this capability to allow a Group to suspend a site
In September, the CTSU Operations Office informed site             from participating on all their studies until the site is in
staff at a relatively large number of CTSU participating           compliance with the Group’s data quality standards.
institutions (189) that if they did not submit the CTSU Ros-
                                                               The lead protocol Group will be responsible for the initial
ter Update Form and assign a CTSU Site Administrator and
                                                               notification to sites of their data submission status. Group
Data Administrator they would lose enrollment privileges
                                                               requirements for reporting differ but may include expected
to the CTSU. Please remember that in addition to the
                                                               data, delinquent data, and queries. The lead Group and the
CTSU, the Cooperative Groups rely on this information to
                                                               CTSU will work to ensure that data quality standards for
send study-related information to the sites. As of October
                                                               each Group are accessible to the participating sites via
13th, sites that failed to update their site contact information
                                                               notifications to the site and/or the CTSU web site. Follow-
were suspended from further CTSU enrollments.
                                                               ing their own policies and procedures, the lead protocol
(Fortunately, after a month of follow-up e-mails and phone
                                                               Group will notify the CTSU of sites that have failed to
calls the number of sites actually suspended was much
                                                               maintain the Group’s minimum quality standards. The
smaller than the original number of sites at risk.)
                                                               CTSU will notify the CTSU site contacts of the possible
The CTSU Membership Coordinator will continue to moni- suspension and allow an arbitration period to resolve the
tor the status of site contact information and will follow-up data issues or address concerns regarding the possible sus-
with sites upon being notified that a contact is out-of-date. pension. Sites that bring their data into compliance within
The CTSU Membership Coordinator is notified of failed          the arbitration period or provide a satisfactory action plan
contacts through a number of avenues including:                (as determined by the lead Group) will not be suspended.
                                                               Sites that fail to meet the requirements during the arbitra-
• CTSU Data Managers
                                                               tion period will be suspended until such time as the CTSU
• Cooperative Group Administrative and Data                    is notified by the lead Group that the site is in compliance
     Management Staff                                          with the Group’s data quality standards.
• Targeted e-mails (delivery failures)
• Site Contact Reports including suspended contacts.           In rare instances the CTSU may be notified that a site is
• Site Updates                                                 being sanctioned by a regulatory agency or by their affili-
                                                               ated Group for a very serious performance violation. In
Once sites are notified to update their contact information consultation with the CTMB, the CTSU may immediately
they will have 30 days to do so before being suspended.        suspend the site from further CTSU enrollments and notify
Follow-up notifications will be sent during the 30 day         the site’s affiliated Group and protocol lead Groups of the
period to ensure site staff and investigators are aware of the suspension. Reactivation of the site will be dependent on
need to update contact information.                            the nature of the violation and the site’s ability to comply
Please remember that an individual designated as a site’s      with the corrective actions outlined by the regulatory
CTSU Administrator and/or Data Administrator can assign agency and/or their affiliated Cooperative Group.
roles to other staff at their site using the Site Roles Applica- More detailed information on the site suspension policy
tion under the RSS tab on the CTSU members’ web site.            will be released at a later date and notification of release
Currently the CTSU is using the role of protocol-level Data will appear in the CTSU Bi-monthly Broadcast.
Manager (DM) as a contact on studies for which CTSU
   Page 4
               CTSU, Issue 12                                                                                November 2008



PACCT-1—Data Management Updates                                                                      By Ginger RILEY
and Reminders
Data Submission Guidelines and an updated CRF packet are available for the TAILORx/PACCT1 study. Both of these
documents are available on the CTSU members’ web site on the PACCT1 protocol page.
Please remember to fax all required data management documents to 1-301-545-0406; do not mail documents to the CTSU for
the TAILORx/PACCT1 study. All documents are available on the CTSU members’ web site. Complete and submit the
TAILORx-specific CTSU Data Transmittal Form for ALL data submissions for a patient for the TAILORx/PACCT1 study.
Please remember to verify and/or update your site contact information for the TAILORx/PACCT1 study via the RSS tab of the
CTSU members’ web site. Please note that you now have the ability to assign one protocol-level data manager (DM) contact
at your site for TAILORx/PACCT1, in addition to site-level Data Administrator and Site Administrator contacts. TAILORx/
PACCT1 delinquency notifications and data clarification forms are provided to only one individual specified in these roles. If
a DM contact is specified for TAILORx/PACCT1 at your site, they will receive these notifications; if no DM contact is speci-
fied for TAILORx/PACCT1, then the Site Data Administrator will receive the notifications; if no Site Data Administrator is
specified, then the Site Administrator will receive the notifications. (Note: Please see the article on page 4 of this issue for
more information about the importance of assigning a Site Administrator and Data Administrator at your site.) Contact the
CTSU Helpdesk with any questions, or if you need assistance.
Please note these additional reminders:
  •   Please redact all confidential patient information from reports prior to submission to the CTSU.
  •   All submitted reports MUST be accompanied by a TAILORx Source Document Tracking Coversheet (SDT), with one
      SDT completed for each submitted report.
  •   All submitted reports must have a TAILORx/PACCT1 patient identification number clearly specified on each page
  •   Labels should not be affixed to case report forms or the TAILORx Source Document Tracking Coversheet; labels may
      be affixed to submitted reports.
  •   Data Clarification Forms (DCFs): clearly state the updated data in the RESOLUTION box on the DCF.
  •   Do not submit amended case report forms. Amended case report forms are not accepted for the TAILORx/PACCT1
      study and will not be processed by the CTSU. Please utilize the Unsolicited Data Modification (UDM) form to submit
      any data changes for paper case report forms that have not been requested by the CTSU.
  •   UDM Forms: please complete one UDM Form for each CRF for which an update is required (for example: if updates
      are required for an On Study CRF, a 6 month Follow Up CRF, and a 12 month Follow Up CRF, then 3 UDMs should
      be completed and submitted (one for each CRF).
  •   Delinquent data notifications are issued monthly on the 1st and 15th.
  •   RDC-based sites only:
      −   Discrepancy Management Please remember to review your patients for discrepancies. There is a high volume of
          outstanding discrepancies for RDC-based patients that needs to be managed.
      −   New CRFs versus Previous Versions When there is a new version of a CRF put into production, data that has been
          entered for a previous version of a CRF will be located under the UNPLANNED PAGES tab; the data should not be
          entered again for the new version of the CRF.

CTSU Presentation at ASCO Workshop                                                                    By Jenny HOPKINS

Aside from the usual presentations at Cooperative Group          quality clinical trials programs. Ms. Denicoff and Ms. Hop-
meetings, CTSU staff occasionally attend other meetings or       kins presented “Making the Most out of the Cancer Trials
workshops on behalf of the project. This past September,         Support Unit (CTSU).” The presentation was a “walk-
Andrea Denicoff, a CTSU Project Officer at the NCI, and          through” of the resources the CTSU makes available to sites,
Jenny Hopkins, CTSU Promotion, Education, and Training           and was very well-received by workshop participants. The
manager, attended a workshop run by the American Society         presentation is now available on the CTSU members’ web site
of Clinical Oncology (ASCO). The 2008 Clinical Trials            under the Education & Promotion tab (or by clicking on the
Workshop: Enhancing Clinical Trials in your Oncology Prac-       title above). We hope that it serves as a good reminder of the
tice, was intended to help attendees and their sites implement   different tools that the CTSU has available.

   Page 5
               CTSU, Issue 12                                                                                  November 2008


New Protocol-Specific Training Tool Released                                                           By Steve RANSDELL

                 The CTSU is pleased to announce the release              −   Required reports;
                 of our newest training support tool. On Octo-            −   Imaging reports;
                 ber 1, 2008 we released the ACOSOG Z1031                 −   Request to terminate patient follow-up; and
                 Protocol-Specific Web-based Training (WBT)               −   Specimen Banking.
                 Tool. This new training module allows study •        Data entry guidelines including:
                 participants to get protocol-specific details            −   Proper date formatting;
prior to beginning data entry for the ACOSOG Z1031 study.                 −   Navigating through electronic forms;
The training module is available via the CTSU’s Learning                  −   Exiting repeating record groups;
Management System (LMS), which is the access point for                    −   Data change reasons; and
Remote Data Capture (RDC)-related training materials. (The                −   Handling discrepancies.
LMS is itself accessible via the RDC tab of the CTSU mem-        •    CRF-specific instructions for these forms (and many
bers’ web site.) The training covers all of the protocol details      more):
that were previously only available during a monthly webcast              −   Clinical Tumor Size worksheet;
led by the ACOSOG Z1031 data management team. While                       −   Adverse Events;
the webcast delivered training will continue to be offered, it            −   Surgery Reports;
will be scaled back and presented only once per quarter. The              −   Mammogram/Ultrasound Reports;
new WBT is available 24 hours per day, 7 days a week.                     −   Study Drug completion; and
The new training module includes the following:                           −   Pre-resection visit.
                                                                  •   Study-specific video demonstrations.
•   Study forms, including pop-up images of sample forms          •   Key contact information.
    and information about where current versions of these
    form are located.                                             This initial study-specific WBT has been developed and pro-
•   Detailed information about the patient enrollment process,    vided as a pilot, and will include an evaluation to garner user
    including:                                                    feedback. The CTSU is optimistic that the new training tool
        −   Required worksheets, forms and reports;               will be well received, and intends to develop additional study-
        −   Description of the form submittal process;            specific WBTs in the future (some of which could be for non-
        −   Enrollment steps for ACOSOG members;                  RDC studies).
        −   Enrollment steps for members of other                 For more information about this new training tool, contact the
            cooperative groups; and                               ACOSOG Z1031 Data management team: Maristel Guardione
        −   CTSU role in the enrollment process.                  (maristellaguardione@westat.com) or Ryan Whitworth
•   Study form guidelines covering:                               (ryanwhitworth@westat.com).
        −   Investigator signatures;

CTSU Customer Satisfaction Survey Results                                                             By Jenny HOPKINS

As we have reported in previous newsletter issues, the CTSU       Web Site Survey (conducted in August 2008):
has been conducting semi-annual customer satisfaction sur-        • Overall impression of the CTSU members’ web site:
veys regarding both the Web Site and the Help Desk. We are          78% are extremely satisfied or satisfied.
presenting here the most salient results from the recent set of
                                                              The CTSU has conducted four surveys each for the Help Desk
surveys. Please recall that our goal is to have at least 75% of
                                                              and the Web Site during the past two years. We have estab-
respondents be satisfied or extremely satisfied with each item.
                                                              lished core sets of questions that have allowed us to analyze
Help Desk Survey (conducted in September 2008):               trends over that time. For the web site in particular, we have
• Overall level of satisfaction with the services provided    begun a large effort to use the collective survey results to di-
   by the Main Help Desk: 89% are extremely satisfied or      rect further web site development. We are currently analyzing
   satisfied.                                                 and consolidating feedback from past surveys, and you can
• Overall level of satisfaction with the services provided by expect to see some changes and improvements to the web site
   the Regulatory Help Desk: 90% are extremely satisfied over the next several months, based both on that feedback as
   or satisfied.                                              well as current web technology trends.
• Overall level of satisfaction with the services provided by As always, we thank all of those who participate on our sur-
   the Patient Registrars: 77% are extremely satisfied or     veys and provide such valuable feedback!
   satisfied.

    Page 6
               CTSU, Issue 12                                                                                 November 2008


Top-Enrolling Investigators                                                                         By Megan ROSSMANN

The CTSU honors top investigators within the CTSU program. Certificates of Excellence are awarded to the five investigators
with the most accruals through the CTSU for each closed study on its menu. A minimum of five accruals per investigator is
necessary to earn an award. The following investigators have recently received certificates for studies that closed between July
2007 and April 2008:

CALGB-90401: A Randomized Double-Blinded Placebo Controlled Phase III Trial Comparing Docetaxel and Predni-
sone with and without Bevacizumab (IND #7921, NSC #704865) in Men with Hormone Refractory Prostate Cancer
        •    Ellen R. Gaynor, MD of Loyola University Medical Center (13)
        •    Christopher John Sweeney, MD of Indiana University Medical Center (12)
        •    George Wilding, MD of University of Wisconsin Hospital and Clinics (10)
        •    Michael Anthony Carducci, MD of Johns Hopkins University (9)
        •    Michael Dennis Keppen, MD of Sioux Valley Clinic-Oncology (7)
        •    Vasileios (Vasily) J. Assikis, MD of Piedmont Hospital (7)

E4A03: A Randomized Phase III Study of CC-5013 plus Dexamethasone versus CC-5013 plus Low Dose
Dexamethasone in Multiple Myeloma with Thalidomide plus Dexamethasone Salvage Therapy
        •    Raul R. Mena, MD of Providence Saint Joseph Medical Center (5)
        •    Burton M. Needles, MD of Saint John's Mercy Medical Center (5)

E2204: An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or
Cetuximab (NSC 714692) in Combination with Gemcitabine and in Combination with
Chemoradiation (Capecitabine and Radiation) in Patients with Completely-Resected
Pancreatic Carcinoma
        •    Ari David Baron, MD of Sutter Health Western Division Cancer Research
             Group (5)

E2603: A Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel
and BAY 43-9006 versus Carboplatin, Paclitaxel and Placebo in Patients with
Unresectable Locally Advanced or Stage IV Melanoma
        •    Bruce G. Redman, MD of University of Michigan University Hospital (17)
        •    Lawrence E. Flaherty, MD of Wayne State University (15)
        •    Ronald C. Deconti, MD of Moffitt Cancer Center and Research Institute (15)
        •    Jose Lutzky, MD of Mount Sinai Medical Center CCOP (9)
        •    Christopher D. Lao, MD of University of Michigan University Hospital (9)
        •    Ernest Carleton Borden, MD of Cleveland Clinic Foundation (9)
        •    Donald P. Lawrence, MD of Massachusetts General Hospital Cancer Center (7)
        •    Kim Allyson Margolin, MD of City of Hope (7)
        •    Jeffrey S. Weber, MD, PhD of Moffitt Cancer Center and Research Institute (6)
        •    Thomas Frank Gajewski, MD of University of Chicago (6)

RTOG-0214: A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With
Locally Advanced Non-Small Cell Lung Cancer
        •    Islam Gharib Mohamed, MD of Cancer Centre for The Southern Interior (8)

Congratulations to all recipients of the Certificates of Excellence! We look forward to acknowledging more investigators for
their contributions to CTSU trial enrollment in the future.


    Page 7
               CTSU, Issue 12                                                                                    November 2008




CTSU to Begin Trial Complexity Payments                                                                   By Donna MARINUCCI

The CTSU is pleased to announce that it will soon begin           treatment trials as part of the Operational Efficiency Initiative
making, via each site’s credited or lead Group, additional        of the NCI’s Clinical Trials Working Group. As one
payments of $1,000 per patient for accruals since June 1,         component of an improved funding model, the goal of the trial
2008, to 14 trials that are considered to have additional com-    complexity program is to use and test algorithms that take into
plexity for accruing sites. Aligning reimbursement with trial     account research-related site costs associated with conducting
complexity is one component proposed for an improved              cancer clinical trials. Studies deemed “complex” based on the
funding model for NCI phase III cancer treatment trials.          10 elements described in the complexity model may be
                                                                  eligible to receive additional funds – when available – beyond
Which Trials Were Selected?
                                                                  the base capitation.
CTEP announced at the Group Chairs meeting on September
19, 2008, that payments would soon begin for accruals to the      What Criteria Were Selected to Support the Trial Com-
following 14 trials:                                              plexity Model?
                                                                  The goal in creating the criteria for a trial complexity model
   ACOSOG-            E1900               NSABP B-40              was to develop a simple, standardized model using a
   Z1041
                                                                  representative number of trial elements deemed to involve
   ACOSOG-            E1A05               RTOG-0534
                                                                  increased effort at the participating sites. These elements are
   Z6051
                                                                  not designed to describe every detail of a trial, but were
   CALGB-140503       GOG-0218            S0518
                                                                  selected as those likely to identify the most time-consuming
   CALGB-90203        GOG-0213*           S0337*                  and complex work for accruing sites. The ten elements are:
   COG                N0577(not yet       * not on CTSU           1)    Number of study arms;
   AAML0531*          activated)          menu                    2)    Complexity of informed consent process;
                                                                  3)    Number of registration/randomization steps;
These trials were selected by CTEP as meriting additional
                                                                  4)    complexity of investigational treatment (in terms of
support in order to stimulate accruals. Each Group had
                                                                        modality, toxicity);
suggested trials warranting such funding. The CTSU has
                                                                  5)    Length of investigational treatment;
received special funding for these payments from NCI’s
                                                                  6)    Feasibility and personnel impact;
Coordinating Center for Clinical Trials (CCCT).
                                                                  7)    Data collection (i.e., AE reporting, scan collection, con
What Dollar Amount Will Be Added for the Selected                       med);
Complexity Trials?                                                8)    Follow-up requirements;
For new accruals, beginning tentatively on November 17,           9)    Ancillary studies; and
2008 the CTSU will automatically add $1,000 to each basic         10)   Participant feasibility and enrollment.
accrual payment for non-CCOP sites; CCOPs will receive an
                                                                  The trial complexity model with the ten elements and scoring
additional 0.5 credit for these trials. For payments to
                                                                  information will be posted in the near future on the CTEP web
members of a lead Group and for the three trials not on the
                                                                  site at http://ctep.cancer.gov/ (entitled “Trial Complexity Ele-
CTSU menu, the lead Group will periodically advise the
                                                                  ments and Scoring Model”).
CTSU of sites to receive payments, on a continuing basis.
                                                              How Will Complex Trials Be Selected in the Future?
Payments for accruals between June 1, 2008 and the date the
                                                              During the next phase of the program, Cooperative Groups
automatic payments begin will be made in two batches.
                                                              will apply the 10 complexity criteria to new phase III cancer
Except for CICRS sites that will receive payments directly, all
                                                              treatment trials and propose complexity scoring of each
payments will be disbursed to Groups, for distribution to their
                                                              criterion, as part of the Protocol Submission Worksheet
members.
                                                              prepared for the CTEP Protocol Information Office. The
How Was the Trial Complexity Model Developed?                 CTEP Protocol Review Committee (PRC) will formally
To develop the model, a Working Group was formed with         review the Group’s assignment of a complexity score, and
members selected by the Group Chair from each of the          either concur or propose modifications. Agreement or
Cooperative Groups, in addition to senior leaders of the CTSU proposed modifications to the trial complexity score will be
and CTEP. The charge to the working group was to develop a communicated back to the Group via memo after PRC review.
model for Phase III and select randomized phase II cancer     The PRC Chair and Group Protocol Chair would discuss and
                                                                                              Continued on next page
   Page 8
               CTSU, Issue 12                                                                                               November 2008


Trial Complexity Payments                                           (Continued from previous page)

resolve any differences in scoring and a final score would be            be compared with those before additional payments began.
set. Groups may also send in a revised scoring along with an             (For trials activated after the program began, historical accrual
amendment if the protocol is later materially changed. How               rates for trials with similar trial complexity will be reviewed.)
many future trials will be approved for complexity payments              Also, qualitative information will be sought from Group
will depend on the availability of additional funds for the              personnel, each study’s chair, and others familiar with
program.                                                                 accruals on a disease-specific basis, such as Group disease
                                                                         committee chairs.
How Will Effectiveness Be Measured?
Accrual rates after complexity payments are distributed will

N0147 Payment Information                                                                                          Provided by NCCTG

On October 21, 2008, the NCCTG released a memo to Principal Investigators and Clinical Research Associates regarding the
new payment schema for N0147. The purpose of this memorandum was to provide notice of new site payments effective with
the Addendum 9 version of the protocol, which became active August 18, 2008. According to the memo:

    Payments are based on enrollment date, arm assignment, sample receipt, and completion of randomization/
    registration, as noted in the table below.
    The study will cover costs for the centralized KRAS testing performed at the NCCTG Research Base (i.e., Mayo
    Clinic) for research purposes. Sites are responsible for KRAS tests requested for clinical purposes and performed
    outside of the NCCTG Research Base (i.e., Mayo Clinic).
    The table appearing below summarizes site reimbursements. All NCCTG sites will be paid through the NCCTG,
    whereas non-NCCTG sites will be paid through the CTSU.

                                               Distribution of Site Payments for N0147
                                                      (As of October 21, 2008)
                                                                                KRAS Testing              Additional Tissue
                                   Assignment to        Assignment to      Performed, but Patient        Submitted in Accord
            Enrollment Date         Arm A or D             Arm G            is NOT Registered to          with Addendum 9
                                                                           Arm G or Randomized             Requirements*
                                                                                to Arm A or D
             Prior to June 1,       Standard NCI              NA                     NA                   $200 payment from
                  2006            payment of $2,000                                                            industry
                                   per patient for
                                    pts on all arms
                                        (A – F)
             June 1, 2006 –         Standard NCI              NA                     NA                   $200 payment from
            August 17, 2008       payment of $2,000                                                            industry
                                  + $2,000 industry
            August 18, 2008         Standard NCI           $500 NCI           $500 NCI payment                    NA
             and forward          payment of $2,000       payment +
                                  + $2,000 industry      $500 industry


        * Sample submission specifications provided in protocol Addendum 9 reflect an increase in the amount of tissue necessary
        to complete existing correlatives, plus KRAS analyses. Requests for additional tissue will be sent to sites in early November
        2008 and via Data Clarification Forms. These requests are based on cases having only the total number of slides submitted
        in accord with pre-Addendum 9 requirements, as identified by the NCCTG. Sites having institutional requirements of re-
        leasing only diagnostic slides prior to centralized pathology review confirming patient eligibility are not eligible for this
        funding and are to submit materials in accord with the most current protocol specifications for sample submission. Further-
        more, the one-time payment of $200 per case is dependent on the additional samples being received at NCCTG.

    For questions, please contact the CRO Finance Office at NCCTG via CROFinance@mayo.edu.

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