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.

 

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AACI Supports NCI Clinical Trials Awareness Campaign

In keeping with Vice President Biden’s Cancer Moonshot goal to expand patient access to new cancer therapies via clinical trials, the Association of American Cancer Institutes (AACI) looks forward to working with the National Cancer Institute (NCI) to increase awareness of NCI-supported clinical trials. We encourage AACI centers to explore novel tools, such as the new application programming interface available from the NCI, to help physicians and patients find information about NCI-supported clinical trials, moving us closer to our shared goal of maximizing patient opportunities to participate in clinical trials.

Read more here:

FACT SHEET: Vice President Biden Announces New Steps to Improve Clinical Trials Essential to Advancing the Cancer Moonshot (The White House)

We Are All Part of the Cancer Moonshot: Vice President Biden on Why Everyone’s Participation in Clinical Trials Matters  (The official Medium account of the Vice President’s Cancer Moonshot)

Meeting Patients Where They Are: Liberating Clinical Trials Data Under the Cancer Moonshot  (NCI Cancer Currents blog)

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.

 

AACI Thanks President Obama, Vice President Biden for Highlighting “Cancer Moonshot”

The Association of American Cancer Institutes (AACI) thanks President Barack Obama for his call for a “cancer moonshot” in his final State of the Union address, and Vice President Joe Biden’s focus on expanded cooperation among cancer centers.

Official_portrait_of_Vice_President_Joe_Biden

Vice President Joe Biden

AACI President George J. Weiner, MD, director of the Holden Comprehensive Cancer Center at the University of Iowa, applauded the President’s remarks, saying:

“It is an incredible time in cancer research and cancer medicine. In many ways, a cancer moonshot is much more challenging than the original moonshot.  There is only one moon, and its behavior is predictable based on the laws of physics.   However, every cancer is different and every patient is different.  Nevertheless, based on years of progress resulting from research conducted in large part at the nation’s academic cancer centers, we now understand cancer better than ever and are advancing clinical care for cancer patients at a rapid pace.”

In a follow-up to the President’s speech, Vice President Biden outlined in a blog post plans to encourage leading cancer centers to reach unprecedented levels of cooperation.  AACI cancer centers currently collaborate in many ways based on the understanding that success in cancer research, education and care is faster when we work together.  The Vice President’s call to action will push AACI cancer centers to a new level of partnership and cooperation. Comprised of 95 premier academic cancer research centers in the U.S. and Canada, AACI is poised to ease the burden of cancer by supporting the ability of its member centers to work together.

“A coordinated cancer moonshot will allow us to accelerate our research progress, thereby reducing the pain and suffering caused by cancer, for current and future generations,” Dr. Weiner said.  “The nation’s cancer centers look forward to working with the President and Vice President to move these general concepts from the drawing board to the launching pad.”

Three New Members Join AACI CRI Steering Committee

AACI congratulates the following new members of the AACI Clinical Research Initiative (CRI) Steering Committee. Each will serve a three-year term beginning September 1, 2015:

  • Rosemarie Gagliardi, Tisch Cancer Institute, Mount Sinai Medical Center
  • Jessica Moehle, BS, CCRP, Huntsman Cancer Institute, University of Utah
  • Steve Williamson, MD, University of Kansas Cancer Center
New CRI Steering Committee members (L-R) Gagliari, Moehle and Williamson.

New CRI Steering Committee Members (L-R) Gagliardi, Moehle and Williamson.

The AACI CRI is a network of cancer center clinical research leaders that examines and shares best practices that promote the efficient operation of cancer center clinical research facilities, and leverages the ability of the AACI cancer center network to advocate for improvement in the national clinical trials enterprise.

Rosemarie Gagliardi is Associate Dean of Research Services, Icahn School of Medicine at Mount Sinai;  Operations Director, Cancer Clinical Trials Office (CCTO), Tisch Cancer Institute; and Assistant Professor, Department of Population Health Science and Policy. The primary mission of the Tisch Cancer Institute Clinical Protocol and Data Monitoring (CPDM) program is to assist investigators in the development, conduct, and reporting of clinical research in an efficient, compliant and scientifically sound manner. The CPDM provides regulatory, budgeting, study management, compliance, data management and reporting services to ensure clinical research uniformity and consistency. Ms. Gagliardi serves as the CCTO Operations Director, a role established in 2011 to provide direct management of CPDM operations.

Jessica Moehle is Associate Director of Operations, Clinical Trials Office, at Huntsman Cancer Institute. She has more than ten years of clinical research experience, including directing operations for the clinical trials office overseeing a staff of 109 FTEs. Prior to this time she served as the Clinical Trials Regulatory Department Manager and specialized in project management, operational leadership, protocol development, clinical trial portfolio management, IRB regulation, IND submissions, FDA regulation, NCI National Reporting criteria, principal investigator and pharmaceutical sponsor relations, clinical trial staff hiring and training. Ms. Moehle also spent several years in pre-clinical office administration at the National Institutes of Health, Division of AIDS, and Vaccine Research Program.

Stephen Williamson is Medical Director, Clinical Trials Research Unit, and Phase I Director, at University of Kansas Cancer Center. He has been involved in clinical trials research since his oncology fellowship, starting in 1984. Dr. Williamson has been involved in clinical trial development locally and nationally through the Southwest Oncology Group (now known as SWOG). Since 1986 he has been active in the Lung, GI and Head and Neck Committees of the Southwest Oncology Group. His first multi-institutional phase II trial through SWOG was initiated in 1986 and he has been the principal investigator on multiple investigator-initiated trials at the University of Kansas, including a phase I gene therapy clinical trial utilizing irradiated autologous melanoma cells adenovirally transduced with the human GM-CSF gene.

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