Answering the Call for Collaboration to Expand Discoveries and Address Disparities

Stanton L. Gerson, MD

AACI President Stanton L. Gerson, MD

Public interest in cancer discovery has incredible traction; many people and institutions across the country are helping to expand the impact of our discoveries and to instill a sense of urgency that every household be included in the benefits of cancer research. I recently learned about some creative, exciting efforts to expand cancer discovery as a panelist at the Biden Cancer Initiative Colloquium, held in April at the American Association for Cancer Research Annual Meeting 2018, in Chicago.

The Biden Cancer Initiative is a nonprofit established by former Vice President Joe Biden and Jill Biden, PhD in June 2017, to accelerate progress in cancer prevention, detection, treatment, and care.

During the panel discussion, I highlighted the ways that Case Comprehensive Cancer Center is addressing disparities in cancer, including a tobacco cessation intervention led by Monica Webb Hooper, PhD. Dr. Hooper became director of Case Comprehensive Cancer Center‘s Office of Cancer Disparities Research in 2016 and was closely involved with the vice president’s visit to Cleveland to learn about the city’s contributions to his “Cancer Moonshot” goals.

Read more from Dr. Gerson, director of the Case Comprehensive Cancer Center in Cleveland, in AACI’s June 2018 Commentary

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Webinar Tackles Clinical Trial Management at Satellite Sites

AACI CRI logo

On Wednesday, June 6, AACI’s Clinical Research Initiative (CRI) hosted “Satellite Locations,” a webinar presented by Andrea Kruse, clinical trials network manager at Dana-Farber Cancer Institute at Harvard Medical School, and Cathy Hugney, RN, CCRP, regional oncology program manager at the Cleveland Clinic Taussig Cancer Center. The discussion was moderated by Laurin Priddy, clinical research manager at Simmons Comprehensive Cancer Center, UT Southwestern Medical Center.

The webinar followed from a lively discussion of the topic on the CRI Listserv, where staff from our 98 member centers crowd-source information from their peers on best practices. In fact, Priddy says she developed the “Satellite Locations” webinar as she solicited help from colleagues to deal with her own “growing pains” related to efforts to institute efficient satellite site communication and clinical trial portfolio expansion at her cancer center. Clearly a hot topic, the webinar attracted 190 registrants from 59 AACI cancer centers – more than half of our member centers.

In addition to Priddy’s wealth of experience, Kruse and Hugney brought their own specialized knowledge. Kruse oversees the research operations of Dana-Farber’s New England network, which consists of four satellite locations, three physician practices, and multiple community hospital partners. The goal of the network, Kruse says, is to increase patient access to high-quality oncology care in integrated community settings while offering access to cutting-edge therapies that are centralized at Dana-Farber’s main campus in Boston. For the past 40 years, Hugney has worked in various capacities at several Cleveland Clinic facilities. Since 2011, she has managed research at eight of its regional sites, including hospitals, family health centers, stand-alone cancer centers and, most recently, community outreach programs.

Kruse and Hugney covered a range of topics, from the structure of their main campus and satellite sites, to how studies are opened at regional sites, how budgets and monitoring visits are managed, and the ways drugs and live tissue samples are transported between locations for storage at the main campus.

A common theme linking the presentations was the role of technology in maintaining connections among primary sites and satellite locations. For instance, Cleveland Clinic Taussig Cancer Center uses Skype to loop satellite staff into disease group meetings and other important discussions at the main campus and submits institutional review board applications electronically for trials. The center also uses shared computer drives and SharePoint, a web-based collaborative platform. Both cancer centers manage medical records electronically via Epic.

Other shared practices between the two systems include granting primary investigators the authority to determine which trials are open at satellite locations, making all Phase 1 clinical trials available to satellite patients, and counting trial participant accrual at satellite sites towards the main campus totals.

Slides and video of the webinar will soon be available through the AACI website. The discussion will continue at the 10th Annual CRI Meeting“Leveraging Change to Advance Cures for Cancer Patients”— slated for July 11-12 in Chicago.

 

AACI Endorses Blue Ribbon Panel Recommendations

The Association of American Cancer Institutes (AACI) strongly supports recommendations issued today by the Cancer Moonshot Blue Ribbon Panel, and thanks the panel’s members who lead AACI cancer centers for their service to the cancer research community.

At the request of the White House, under the leadership of Vice President Joe Biden, the Blue Ribbon Panel has produced a report outlining areas of urgent action to speed progress in the field of cancer research. brp-report-cover

The panel, comprised of scientific experts, cancer leaders, and patient advocates, includes four AACI cancer center directors: Mary Beckerle, PhD,CEO and Director, Huntsman Cancer Institute, Salt Lake City; Chi Van Dang, MD, PhD, Professor of Medicine and Director, Abramson Cancer Center, University of Pennsylvania, Philadelphia; Augusto Ochoa, MD, Professor of Pediatrics and Director, Stanley S. Scott Cancer Center Louisiana State University, New Orleans; and, Jennifer Pietenpol, PhD, Professor of Oncology, Professor of Biochemistry, and Director, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee. In addition, Laurie Glimcher, MD, Professor of Medicine and Dean, Weill Cornell Medical College, is incoming President and CEO, Dana-Farber Cancer Institute, Boston.

The report’s recommendations include a focus on areas where we are poised to accelerate scientific progress as well as patient involvement, developing a “national cancer ecosystem” and working together to share data and results more effectively.

“As a primary source for the generation, collection and use of molecular, clinical and outcomes data, AACI and its member cancer centers fully support the Blue Ribbon Panel’s call to revolutionize the generation and sharing of medical and research data,” said AACI President George J. Weiner, MD.

Dr. Weiner stressed that steady, predictable funding for the National Institutes of Health and the National Cancer Institute is vital as cancer centers work to share data and improve information systems and communication across the cancer continuum. Streamlining regulatory oversight of these efforts, while also protecting patient privacy, is central to optimizing progress.

A key element of AACI’s mission is helping cancer centers keep pace with the changing landscape in science, technology and health care. The Blue Ribbon Panel report notes that “the vast majority of Americans do not have easy access to precision cancer testing since oncology clinical trials are offered mainly at large academic cancer centers and not at community cancer centers where most cancer patients receive their treatments.” In July, AACI presented a white paper to the Office of the Vice President detailing AACI President-Elect Stanton L. Gerson, MD’s presidential initiative to include the academic cancer centers as the focal point for broader community access. The white paper focused on the deep impact AACI centers have on cancer care and novel therapy through clinical trials.

“AACI looks forward to collaborating with the members of the Blue Ribbon Panel in order to implement their important recommendations and to meet the Vice President’s goal of ending cancer as we know it,” said AACI Executive Director Barbara Duffy Stewart, MPH.

U.S. Representatives Castor, Fleischmann to be Honored as part of Capitol Hill Day Advocacy for Cancer Research Funding

The Association of American Cancer Institutes (AACI), the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) will honor Representatives Kathy Castor (D-FL) and Chuck Fleischmann (R-TN) for their outstanding leadership on behalf of cancer research at a reception on May 11. On May 12, cancer researchers, physicians, survivors, patient advocates, and cancer center directors associated with AACI, AACR, and ASCO will call on Congress to provide robust, sustained, and predictable funding increases for the National Institutes of Health (NIH) and the National Cancer Institute (NCI) in Fiscal Year 2017 and beyond.

Reps. Castor and Fleischmann have been outspoken supporters of the NIH and the NCI. Since first taking office in 2007, Congresswoman Castor has been a champion for cancer research and has fought tirelessly for increases to the NIH budget and for research funding through other federal agencies. A strong proponent of cancer prevention, for the past two years Castor has spearheaded a far-reaching campaign to promote awareness of the HPV vaccine and how it can prevent all kinds of cancers. She also joined her colleague Rep. Renee Ellmers (R-NC) in working to advance the Accelerating the End of Breast Cancer Act, H.R.1197, to the House floor for a vote earlier this year.

Rep. Fleischmann has represented the third district of Tennessee since 2010. He currently serves on the House Appropriations Subcommittee on Labor, Health and Human Services where he is a devoted advocate for the cancer community. Representative Fleischmann encourages cancer patients to share their stories and has further opened the dialogue in Congress about the need for more research to bring more cures. He has repeatedly called for a national commitment to defeat cancer, and readily shares his personal experiences to bring hope to others.

In 2015, Congress passed a bipartisan spending bill, which provided the NIH with a $2 billion increase in federal funding for FY 2016- the largest boost in annual appropriations for the NIH in more than a decade. Cancer researchers, physician scientists, the nation’s cancer centers and cancer patients depend on robust, predictable and sustainable funding increases for the NIH and NCI in order to increase the pace of progress against cancer.

For the past 10 years each May, which is National Cancer Research Month, the three largest organizations representing more than 60,000 cancer researchers and community oncologists, and 95 cancer centers across the U.S. converge on Capitol Hill to share how cancer research is saving lives and transforming patient care. This year, advocates will thank Members of Congress for their renewed commitment to NIH and NCI in FY 2016, and they will urge Congress to continue the momentum by providing a $2.4 billion increase for the NIH in FY 2017.

 

Fresh Faces on House Subcommittee Offer Potential for Improved Appropriations Process

Earlier this week, the House Appropriations Subcommittee on Labor, Health and Human Services (HHS), Education, and Related Agencies held the first hearing of the year on the National Institutes of Health (NIH) fiscal year (FY) 2016 budget request.

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NIH Director Dr. Francis Collins

Panelists included NIH director, Dr. Francis Collins, Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases, Dr. Gary Gibbons of the National Heart, Lung and Blood Institute, Dr. Tom Insel of the National Institute of Mental Health, and Dr. Nora Volkow of the National Institute on Drug Abuse.

In his remarks, Dr. Collins noted that the NIH has worked diligently to enhance human health, lengthen life, and reduce illness and disability. He acknowledged that the leadership, employees, and grantees passionately believe in the NIH’s mission. He said that the foundation of basic science has driven NIH’s ability to understand disease for more than a century through diagnosis, treatment and prevention.

Dr. Collins stressed the NIH’s intent to lead the charge on the recently unveiled Precision Medicine Initiative (PMI). He reminded the subcommittee that the near term goal of the PMI focuses on cancer and added that cancer research has been leading the way in precision medicine for many years, by defining the driver mutations in individual tumors and using this information to design ideal therapies for each patient. He said the PMI seeks to accelerate discovery and expand current cancer genomics research to understand the development of resistance to targeted therapy, to apply non-invasive methods to track patients’ responses to treatment, and to explore the efficacy of new drug combinations targeted to specific tumor mutations. Highlighting a young woman’s epidermal growth factor receptor (EGFR) mutation and her positive response to the drug Tarceva, Dr. Collins said the PMI would allow researchers to do groundbreaking, historic work.

Dr. Collins noted that the President’s FY 2016 budget request for the NIH is $31.311 billion ($1 billion above the enacted FY 2015 level). Supporting the president’s request would allow 10,303 new and competing Research Project Grants (RPGs) to be funded in FY 2016, an increase above FY 2015 grant levels. The budget would also provide the capacity to improve the health of our nation and the ability to maintain the U.S.’ standing in biomedical science and develop new therapies, he said.

Reminding the subcommittee that China is now filing more patents in medicine than the U.S., Dr. Collins said that we are in danger of relinquishing our standing in biomedical research. While the subcommittee’s Ranking Member Rosa DeLauro (D-CT) recommended doubling the NIH budget, Dr. Collins suggested the best thing for the NIH would be a budget that is on stable growth trajectory and that keeps pace with inflation, plus a little bit more, which would allow the U.S. to flex its innovative muscles.

Chairman Tom Cole (R-OK) communicated his commitment to making NIH funding a priority for the subcommittee and offered to do what he can to support the NIH, despite funding restrictions imposed by budget caps.

Jennifer W. Pegher, AACI Government Relations Manager

On The Hill: Cancer Center Directors, Patient Advocate Stress Need for Increased Funding

On February 11, AACI hosted an educational briefing on Capitol Hill, with support from the American Association for Cancer Research (AACR) and in cooperation with the House Cancer Caucus. The briefing focused on educating new legislators, their staff, and Hill veterans about the importance of the nation’s cancer centers. The panelists were: AACI President George J. Weiner, MD, director, Holden Comprehensive Cancer Center; Roy A. Jensen, MD, director, The University of Kansas Cancer Center; Candace S. Johnson, PhD, president and CEO and director, Roswell Park Cancer Institute; and Averl Anderson, a patient advocate from Buffalo, New York.

GR education panel Feb 2015

AACI Capitol Hill cancer research briefing: (L-R) Cancer center directors George Weiner, Roy Jensen and Candace Johnson, with patient advocate Averl Anderson.

As the panel’s moderator, Dr. Weiner, who also serves as vice chair of AACR’s Science Policy and Government Affairs committee, highlighted the role that cancer centers play in conducting and supporting multidisciplinary cancer research; training cancer physicians and scientists; providing state-of-the-art care and disseminating information about cancer detection, diagnosis, treatment, prevention, control, palliative care, and survivorship.

Despite significant progress in combating the disease, the cancer community still faces difficult challenges, Dr. Weiner said. For example, many new ideas are going untested because of shrinking resources–the NIH budget has dropped 24 percent ($6.5 billion) since 2003, when accounting for inflation in the cost of biomedical research, and NCI’s budget has been cut 26.4 percent ($1.2 billion).

Dr. Johnson recalled the many opportunities that were available to her when she was a young scientist, but she is now concerned that stagnant funding will drive today’s budding scientists out of the field, thus impeding research progress.

“If we didn’t have these [cancer] centers it would be a loss to patients and everyone in the country,” Dr. Johnson said.

Dr. Jensen, whose center received NCI designation in 2012, also highlighted cancer centers’ role in driving research, stressing the need for predictable federal funding in order for cancer centers to make faster progress.

Ms. Anderson discussed her volunteer work with the Roswell Park Buffalo/Niagara Witness Project, a program targeting underserved women in Buffalo. In 2008 the Witness Project set a goal to recruit 200 women to acquire mammograms. Ms. Anderson was the 200th volunteer and the only one to be diagnosed with breast cancer. She said that the mammogram saved her life; she also credited the care that she received as part of a clinical trial at Roswell Park Cancer Institute.

Ms. Anderson urged that myths about cancer prevention and detection and the history of cancer be dispelled. In some communities, especially minority communities, cancer diagnoses are not discussed among families and friends, she said, noting that in some homes it is taboo for children to hear about aunts, uncles and parents with cancer.

“Cancer is growing. We need to grow with it and funding must grow with it,” she said.

Jennifer W. Pegher, AACI Government Relations Manager

Case Study: How AACI’s Clinical Research Initiative Helps to Improve Clinical Trial Management

G  Radakovic

Dr. Gospova Radakovic, Director, Office of Clinical Research, University of Virginia Cancer Center

Over the past year, Dr. Gospova Radakovic, director of the Office of Clinical Research at the University of Virginia (UVA) Cancer Center, has been searching for ways to shorten UVA’s clinical trials activation timeline. At the 6th Annual AACI CRI Meeting in Chicago, Dr. Radakovic attended a session entitled, “Death by Startup: Clinical Trial Activation Challenges”, to learn about how her colleagues communicate with the multiple institutional departments (e.g., regulatory, finance administration, budgeting and contracting, pharmacy, pathology, radiology, laboratory, clinical staff) that are involved in the review and approval of oncology trials.

One of the session’s panelists, Dr. Vicki Keedy, Assistant Medical Director, Clinical Trials Shared Resource at Vanderbilt-Ingram Cancer Center, talked about Vanderbilt’s Clinical Research Implementation Committee (CRIC). CRIC is comprised of permanent members representing various departments–bio-specimen, budget, clinic, infusion, patient management, pharmacy, radiology, regulatory–and ad hoc members from departments including pathology, ophthalmology and dermatology. It meets bimonthly to discuss new protocols and to address questions each department may have about opening and conducting a trial. CRIC meetings are an opportunity to address concerns prior to a trial being reviewed by the institution’s regulatory committees. Since the implementation of the bimonthly committee reviews, Vanderbilt has minimized delays in its trial review process.

When Dr. Radakovic returned to UVA, she created a CRIC committee focused on the following objectives:

  • Provide oversight for oncology trial activation.
  • Clarify resources needed for trial implementation and coordination.
  • Facilitate communication between all internal stakeholders working with the trial, from trial receipt to trial implementation.
  • Assign accountability for all tasks necessary for trial activation and completion.

Dr. Radakovic chairs the bimonthly UVA Cancer Center CRIC meetings which include investigational pharmacists, research nurses, regulatory coordinators, budget managers, and research group managers. Since the committee’s formation, UVA has seen improvement in the Clinical Research Office’s communications with internal stakeholders, leading to smoother and more productive site initiation processes. Also, the CRIC review has helped to prioritize the application of limited trial resources, leading to a broader range of available trials.