1. Eastman, Peggy

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About 24 new cancer center directors gathered at the annual meeting of the Association of American Cancer Institutes (AACI), held in Washington, D.C. AACI is a membership organization of 97 academic and freestanding cancer research centers in the U.S. and Canada.

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The new cancer center directors are assuming leadership positions at the same time a new NCI Director is taking the helm. Norman "Ned" Sharpless, MD, was recently sworn in to oversee the NCI, and cancer center directors are getting one of their own. Sharpless is a former Director of the NCI-designated Lineberger Comprehensive Cancer Center at the University of North Carolina School of Medicine, Chapel Hill, as well as the former Wellcome Distinguished Professor in Cancer Research there. He has served on the AACI Board of Directors. NIH Director Francis Collins, MD, PhD, welcomed the appointment, calling Sharpless "an outstanding scientist, clinician, and administrator."


Citing "the dramatic turnover in cancer center leadership," AACI President Stanton L. Gerson, MD, said the new cancer center directors represent "a watershed opportunity to reinvigorate our focus and determination." Cancer centers are at the forefront of the national effort against cancer, since they combine research, clinical care, training, and community outreach, noted Gerson, Director of the Case Comprehensive Cancer Center at Case Western Reserve University, Cleveland.


Sen. Roy Blunt (R-Mo.), a co-recipient of the 2017 AACI Distinguished Public Service Award (with Sen. Bob Casey, D-Pa.), said this is an especially exciting time for cancer center leaders, because cancer treatment has "moved from an infant science to a science that's based on a whole new set of facts." Blunt, a strong supporter of funding for the NIH in Congress, paid tribute to Francis Collins, MD, PhD, whose research on the Human Genome Project helped pave the way for the advances of precision medicine. Precision medicine was featured in a session at the AACI meeting.


While the U.S. cancer treatment discussion has been ongoing, "the cure discussion is a different kind of discussion," emphasized Blunt. Now, he said, precision medicine has the potential to make more cures a reality, and so the discussion is shifting to a question: How is the nation going to make that transition from treatment to cure?


One way is to increase participation in cancer clinical trials and improve the clinical trials process and infrastructure. In 2016, the Clinical Research Initiative of AACI issued a progress report, Charting a Path to Improved Cancer Clinical Research, which focused on increased efficiency and improved management of trials. In partnership with AACI, ASCO launched an effort to identify best practices in cancer clinical trials, especially solutions to dealing with regulatory and administrative requirements.


Trial Compliance

At this year's AACI meeting, the first-place abstract from AACI's Clinical Research Initiative, "Ensuring PEAK Training and Compliance in Cancer Clinical Trials," featured a study focused on ensuring the highest level of training and compliance of infusion nurses to improve the efficiency and quality of trials. Noting that a large proportion of oncology clinical trials require IV infusions of cancer drugs, co-authors from the Tisch Cancer Institute at the Mount Sinai Health System found that "A comprehensive understanding of the appropriate administration of such therapies, potential adverse events, and study procedures is critical to minimizing protocol deviations and optimizing patient safety."


But the Tisch researchers, led by Richa Upadhyay, MD, found that infusion units are typically staffed by nurses who "simultaneously care for patients receiving study drugs and standard-of-care therapies." These nurses essentially sit outside of the institutional research organizational structure, which the authors observed complicates the delivery and documentation of appropriate, needed education and training. In an internal audit, the authors found that as a result of inadequate training, "a percentage of study infusions were administered by a nurse who had not been adequately trained. The lack of training was attributed to employee turnover, increase in clinic volume, time between in-service and first patient enrolled, and study amendments."


Solutions to these problems were implemented. The infusion nursing staff are now trained in regulatory requirements and good clinical practices; alerts are received by nursing leadership when new research patients enroll, allowing scheduling with appropriately trained staff; a new online module using the existing web-based Portal for Education and Advancement of Knowledge (PEAK) replaced paper systems for RN training specific to oncology trials; and confirmation of training was instituted on days of treatment.


Equally important, nursing leadership at the Tisch Cancer Institute identified a group of infusion nurses to serve as lead infusion nurses for clinical trials, and two new nursing positions were created to be the nursing navigators in liaison with the research staff. The authors of this study concluded that engaging nurse leadership, along with use of information technology, was "essential in changing the culture and enhancing educational requirements for infusion nurses." Regular audits of training compliance will be done.


Asked to comment on the significance of this study, AACI Director of Programs Janie K. Hofacker, RN, BSN, MS, told Oncology Times, "It's very important for nurses to feel part of the clinical trials process, especially in oncology." Hofacker is a former clinical research director. This year AACI partnered with the Oncology Nursing Society (ONS) on the ONS Policy Summit, Approaches to Patient Centered Care, held at the National Press Club on the last day of the AACI meeting in Washington.


Community Collaboration

At the AACI meeting, a session focused on clinical trial deployment within the community, emphasizing the importance of cooperative working partnerships between academic cancer centers and professionals in the community. For example, St. Jude Children's Research Hospital in Memphis, Tenn., has eight affiliates in the U.S. and multi-site clinical collaborations, said Victor M. Santana, MD, Associate Director for Clinical Research at St. Jude's Comprehensive Cancer Center.


"Every pediatric cancer is rare compared to adult cancers," so rare that "you really need to collaborate," stressed Santana. While recognizing that parents are willing to travel anywhere for a sick child, St. Jude staff understand that travel to a cancer center for a clinical trial can impose a burden on the family, he noted. So the cancer center has developed a flexible shared patient model at other sites with access to a centralized institutional review board (IRB).


"We have been moving in the direction of more adaptive monitoring," added Santana, noting that in addition to the affiliate sites, the cancer center has collaborating clinical trial sites, which are study-specific. Not only do the affiliated sites and collaborating sites provide more access to patients closer to their homes, but these sites also provide an opportunity to serve under-represented populations, he noted. In addition, Santana said, "there's not a lot of money out there for pediatric clinical trials," so the affiliates and collaborating study sites help to stretch the dollars available for pediatric research trials.


Santana stressed that it is important for the affiliated site leaders to feel like integral parts of the clinical trial structure. "One of the things that we've tried to do is make sure affiliate clinical research administrators really believe they're part of the trial," he noted. Therefore, clinical trial personnel at affiliated sites are invited to attend a conference every year at the "mother ship," St. Jude, said Santana. Participation in this conference helps to confer a sense of belonging, he said.


"We are a consortium cancer center," said AACI President-Elect Roy A. Jensen, MD, Director of the University of Kansas Cancer Center in Kansas City. Faced with the challenge of about 4.4 million people in a catchment area of 123 counties, 78 percent of which are rural or frontier, cancer center administrators chose the solution of forming the Midwest Cancer Alliance (MCA) network of institutions, said Jensen. "We work collaboratively with these sites to understand their needs," he said. The motto of the MCA is "More Options. Close to Home." Jensen noted that one of the things that surprised him was the amount of turnover in many health care centers in rural areas. That, he said, is due to the fact that droves of young people are heading off to relocate in cities like Denver, while leaving older people to age in place.


In the process of working with community health professionals, Jensen said he and his colleagues discovered that there is a very low rate of HPV vaccination, recommended to prevent female cervical cancer and anal cancer in males. So, he said, the Kansas Cancer Center professionals began reaching out to private practitioners to boost that vaccination rate.


In Pennsylvania, about 60 clinical care network sites come under the umbrella of the University of Pittsburgh Medical Center Hillman Cancer Center network, said Robert L. Ferris, MD, PhD, Director of the Hillman center. He noted that committee members collaborate to define a single best treatment strategy for each stage of disease, based upon efficacy and toxicity.


"We're constantly trying to communicate with our community sites," said Ferris, adding that he has found a great deal of interest in clinical trials on the part of community oncologists. But he also noted that community oncologists are so pressed for time that the clinical trials process needs to be as smooth and free of roadblocks as possible. Ferris said the message that has come back loudest and clearest related to clinical trials from community oncologists is, "make it easy." Thus, he said, it is important to have enough clinical research coordinators available. Ferris' goal is to provide cancer patients in all 29 counties of western Pennsylvania with more convenient access to clinical trials.


In New Mexico, the not-for-profit New Mexico Cancer Care Alliance encompasses five hospitals/health systems, said Teresa L. Stewart, MHA, Director of the Clinical Research Office at the University of New Mexico Comprehensive Cancer Center in Albuquerque. "We are a very large geographical state," said Stewart, and the state also has a rich multi-ethnic heritage. To enhance efficiency and timely coordination of trials, "we really try to centralize what we can," said Stewart, noting that a centralized IRB based on authorization agreements helps the process of coordination.


Speakers at the AACI clinical trials session noted the need to decrease staff turnover and retain trained personnel at cancer centers and their member sites to help the clinical trials infrastructure run as smoothly as possible. But, noted Santana, while "there are a lot of things you can do about retention"-such as conferring employee recognition awards-"unfortunately a lot of people will leave and you have to start all over again."


Peggy Eastman is a contributing writer.