PLCO Etiology and Early Marker Studies (EEMS)
To: Potential EEMS Investigator
From: EEMS Coordinating Center
Regarding: PLCO Etiology and Early Marker Studies (EEMS) 2007 Review Cycle
Date: April 16, 2007

This memo is an official announcement that the PLCO EEMS review process will be accepting proposals for use of the PLCO biorepository materials twice for calendar year 2007. Applications for the first round for 2007 will be June 1, 2007 through June 29, 2007 at 5 PM EDST. The second round will be from December 1, 2007 through December 29, 2007 at 5 PM EST. Another announcement will be sent eight weeks prior to the open season for receipt of applications in December. We trust that this advance notice will allow you to plan more appropriately for your research activities this calendar year. We plan to continue twice yearly rounds for application acceptance during the months of June and December if budgetary constraints allow.

Please distribute this notice to those individuals with whom you work that may be interested in submitting an EEMS application.

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial is a large population based randomized trial evaluating screening programs for these cancers. The PLCO Biorepository contains approximately 2.7 million biologic specimens, including blood specimens collected from intervention participants during their six trial screening years and buccal cell specimens collected from control participants. The Etiology and Early Marker Studies (EEMS) is a component of the PLCO Trial designed to facilitate research in early detection and molecular epidemiology of cancers using Trial collection specimens.

The EEMS application materials ( the EEMS application forms, instructions, applicant’s checklist, NIH biosketch, confidentiality disclosure agreement (CDA), and the EEMS policy document), as well as general information regarding the EEMS review process can be found under the PLCO EEMS tab on the Program Administrative Resource (PAR) PLCO website (www.parplco.org). Individuals who do not already have access to PAR should contact the PAR PLCO Helpdesk (parplcohelpdesk@westat.com) and request permission to access the EEMS tab on the website. Individuals who currently have access to PAR should already be able to access to the EEMS tab; please contact the PAR PLCO Helpdesk (parplcohelpdesk@westat.com) with any problems.

Once your proposal is received, the EEMS Coordinating Center will verify that all components are completed and forward the completed proposal packet to the EEMS Principal Investigator, the PLCO Project Officer and Chief Statistician for an initial suitability review. This initial review will be completed around the end of August 2007. Potential investigators will be notified of the results of the suitability review. After the suitability review, the EEMS Review Panel will review and comment on all suitable proposals. It is anticipated that this review will be completed by mid–October, contingent upon the quantity of proposals received. The EEMS PI and the PLCO PO will then make the final decision regarding all acceptable proposals based on input from the EEMS Review Panel.

Please submit completed proposal application and associated materials to the EEMS Coordinating Center at the following address: plco-eems@westat.com

New Cancer Centers Branch Program Director
Join us in welcoming Dr. Hasnaa Shafik as a new Program Director in the Cancer Cancers Branch. Dr. Shafik joined the NCI Office of Cancer Complementary and Alternative Medicine’s program staff in 2003. In early 2005 she assumed a new role as a Scientific Review Administrator in the NCI Division of Extramural Activities. She was in charge of the Prevention, Control and Population Sciences Special Emphasis Panel which reviews Program Projects and multi–site clinical trials.

Dr. Shafik earned her Medical Degree, and Masters in Public Health from Ain Shams University, Cairo Egypt. Through the Fulbright program she was awarded a fellowship at the University of Texas Medical Branch in Galveston (UTMB) to study the mechanisms of induction of cancer with emphasis on chemical carcinogenesis. She then joined the Graduate School at UTMB and earned a PhD in Preventive Medicine and Community Health with a major in genetic/environmental toxicology. Dr. Shafik’s research mainly focused on mechanisms of leukemogenesis in patients with Down syndrome. She identified non–random chromosomal breakpoints in 16 bands throughout the genome that could be used as a surrogate for early detection of predisposition to leukemia. She was awarded the March of Dimes’ Birth Defect Foundation Merit Award and Katherina Seibert Award for her research on Down syndrome and cancer.

Dr Shafik was a faculty member in the medical school in Egypt, and later chaired the Department of Pathology and Microbiology at Texas Chiropractic College. She had committee responsibilities nationwide; serving on the Microbiology and Public Health testing committee in the National Board of Chiropractic examiners and as site team member on the Council on Chiropractic Education to evaluate basic science programs in chiropractic colleges for accreditation.

NCI Staff Attends AACR Conference in Los Angeles
Drs. Bhorjee, Ellis, Shafik, and Vembu (CCB Program Directors) and Ms. Patricia Winkler (CCB IT Specialist/Program Analyst) will be attending the AACR Conference in Los Angeles in April. If you would like to arrange a meeting with one of our program directors, or with Ms. Winkler in relation to data summary issues, please contact Ms. Joyce Linder, our program assistant, at (301) 496–8531. —posted 3/2/2007

New Scientific Review Administrator for Subcommittee A
Dr. Gail Bryant has been appointed as the Scientific Review Administrator for NCI Initial Review Group Subcommittee A for cancer center reviews. Dr. Bryant’s medical education and training, extensive translational research experience, and many years of outstanding service in NCI extramural review activity provide a superb background for this position. In addition, she has organized and managed site visit reviews for Cancer Center Support Grant applications for 12 years, receiving accolades from both reviewers and applicants for her work. Further, she has been closely involved in the management of the Subcommittee and has served as a full partner in developing and implementing Subcommittee and CCSG review practices and procedures.

Cancer Center Directors Working Group Report
At the November 7, 2006 Center Directors Retreat, a small working group chaired by Dr. John Mendelsohn was asked to produce a report providing a blueprint for achievement of a series of goals that included reducing the burden of cancer through strategies in prevention, detection, treatment, and survivorship and identifying ways in which NCI–designated Cancer Centers could enhance collaborative activities and provide leadership in dissemination of best practices. The final report was presented to the National Cancer Advisory Board this morning by Drs. Mendelsohn and Abeloff. Also available is a complementary document outlining survivorship activities at Cancer Centers. You will receive hard copies of these reports by mail in October.

2006 Annual Report to the Nation
The following press release regarding the 2006 Annual Report to the Nation is now available online at http://www.cancer.gov/newscenter/pressreleases/ReportNation2006Release.
In addition, a Q&A regarding the report is available at http://www.cancer.gov/newscenter/pressreleases/ReportNation2006QandA.
You can access the full report at http://www.interscience.wiley.com/cancer/report2006. These materials are also available in Spanish at http://www.cancer.gov/espanol/news. - posted 9/6/2006

President Bush Appoints Dr. Niederhuber as NCI Director
Yesterday President George W. Bush announced his intent to appoint of John E. Niederhuber, M.D. as Director of the National Cancer Institute http://www.whitehouse.gov/news/releases/2006/08/20060815-1.html. A nationally renowned surgeon and researcher, Dr. Niederhuber has dedicated his entire academic career to the treatment and study of cancer - as a professor, cancer center director, National Cancer Advisory Board chair, external advisor to the NCI, grant reviewer, and laboratory investigator supported by NCI and the National Institutes of Health. Dr. Niederhuber joined NCI in September 2005 as NCI's Chief Operating Officer and Deputy Director for Translational and Clinical Sciences, and was appointed Acting Director in June 2006. Additional information on Dr. Niederhuber can be found at http://www.cancer.gov/aboutnci/directorscorner/jen.
- posted 8/16/2006

2007 Cancer Center Directors Retreat
The Spring 2007 Cancer Center Directors Retreat has been scheduled for Monday and Tuesday, April 30 - May 1st, 2007 at the Doubletree Hotel in Bethesda, Maryland. As with the May 2006 Retreat, the 2007 meeting will be scheduled to start at approximately 6:00 p.m. on April 30th and adjourn on the next day at approximately 4 p. m. An agenda and details on hotel reservations will be posted later.

Please contact our office (301-496-8531) if you have questions. - posted 8/15/2006

Peer Evaluation of Minority/Gender Representation

At the May 1-2, 2006 Center Directors Retreat, we announced a policy clarification for peer evaluation of minority and gender representation. In keeping with the original legislation, NIH policy, and CCSG Guidelines, reviewers now will be asked to assess accrual to both therapeutic and non-therapeutic interventional clinical trials. As a reminder, please note that per CCSG Guidelines instructions, accrual data for non-interventional studies (e.g., epidemiologic, health outcome, observational studies, etc.) are not to be reported.

Registering Trials with the PDQ Registry
The National Cancer Institute’s (NCI’s) PDQ® Cancer Clinical Trials Registry is a searchable database of more than 3,800 active and 15,000 closed clinical trials available on the NCI Web site (www.cancer.gov/clinicaltrials). Patients, physicians, clinical trial support staff, and researchers perform more than 180,000 searches per month on this site to find clinical trials. NCI’s Cancer Information Service (1-800-4-Cancer) also uses this database to respond to more than 8,000 inquiries per year about clinical trials. We encourage your Cancer Center investigators and clinical trial support staff to take advantage of this service to register their clinical trials in a publicly accessible database.

Key advantages of registering trials with PDQ include the following:

• Clinical trials listing prepared at no cost to Cancer Centers. Trained NCI contract staff summarize key aspects of the protocol, including eligibility criteria, in a standardized manner, for patients and health professionals. Cancer Center personnel need only provide the protocol document, a copy of the informed consent, and the approval by an Institutional Review Board to PDQ; NCI handles the rest. (See reference document for details.)
• Compliance with FDAMA Section 113. NCI registers trials submitted to PDQ with the National Institute of Health’s ClinicalTrials.gov registry. This enables trial sponsors to meet regulatory requirement under Section 113 of the Food and Drug Administration Modernization Act (FDAMA) that requires registration of all Phase II, Phase III, and Phase IV treatment cancer trials in ClinicalTrials.gov. We also provide investigators with the ClinicalTrials.gov registration number, the NCTID, which can be used as proof of trial registration when trial results are submitted to medical journals for publication.
• Compliance with ICMJE requirements for trial registration. The International Committee of Medical Journal Editors (ICMJE) has made trial registration in a publicly accessible database a condition for publishing results of clinical trials in major medical journals. PDQ helps investigators meet this requirement without an additional burden because the trial listings are provided to ClinicalTrials.gov, the registry identified by ICMJE.
• Identification as NCI-sponsored trials. Trials being conducted with NCI grant funding are identified as NCI-sponsored trials. This designation is used by the Department of Veterans Affairs and Department of Defense health systems, as well as by state agencies, to verify eligibility for insurance reimbursement.
• Greater visibility for trials at Cancer Centers. Besides providing visibility for Cancer Center trials on the NCI Web site, PDQ Clinical Trials Registry is also licensed to other major Web-based clinical trials service providers such as EmergingMed (which powers the American Cancer Society’s clinical trials search), TrialCheck® (Coalition of Cancer Cooperative Groups’ search engine), and CenterWatch. Cancer Centers can also include links to clinical trial descriptions in PDQ from their Web sites, without expending resources on creating separate descriptions.

First Generation Guidelines for NCI-Supported Biorepositories

In 2002 the NCI launched a multi-year process intended to unify policies and procedures for NCI-supported biorepositories. This included a 2004 report compiled for the National Cancer Advisory Board that showed considerable heterogeneity in biorepository management practices across the Institute. In response to the report, the NCI took several steps, including the establishment of a Biorepository Coordinating Committee (BCC) in early 2005. This committee works in an advisory capacity with the NCI Office of Biorepositories and Biospecimen Research (OBBR) (http://biospecimens.cancer.gov/), which is headed by Dr. Carolyn Compton, to coordinate and optimize biospecimen resources for the broad cancer research community. During the summer of 2005, the BCC and OBBR held two workshops focusing on operational and ethical, legal and policy issues in biorepository management and biospecimen research. The workshops included representatives with diverse expertise from the cancer research, patient advocate, and bioethics communities. The initial outcome of these workshops is a document entitled First-Generation Guidelines for NCI-Supported Biorepositories. These Guidelines were approved by the National Cancer Advisory Board at its December 2005 meeting.

Discontinuation of Mailed Summary Statements

Effective October 1, 2005, the NIH discontinued mailing of hard copies of Summary Statements (http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-075.html), including those for P30 Cancer Center Support Grant applications. Investigators are now instructed to use the eRA Commons, a Web interface for electronic conduct of business between the NIH and applicant organizations, to retrieve these statements. Applicant organizations must be registered in the eRA Commons before an account can be established for the investigators and e-notification of Summary Statement availability can occur. Your institutional Office of Sponsored Research Programs should be able to provide guidance on registration procedures if you are not already registered. - posted 9/8/2005