COVID-19, Social Justice, and Clinical Cancer Research

The COVID-19 pandemic and related socioeconomic events have markedly changed the environment in which cancer clinical trials are conducted. These events have resulted in a substantial, immediate-term decrease in accrual to both diagnostic and therapeutic cancer investigations as well as substantive alterations in patterns of oncologic care. The sponsors of clinical trials, including the United States National Cancer Institute, as well as the cancer centers and community oncology practices that conduct such studies, have all markedly adapted their models of care, usage of health care personnel, and regulatory requirements in the attempt to continue clinical cancer investigations while maintaining high levels of patient safety. In doing so, major changes in clinical trials practice have been embraced nationwide. There is a growing consensus that the regulatory and clinical research process alterations that have been adopted in response to the pandemic (such as the use of telemedicine visits to reduce patient travel requirements and the application of remote informed consent procedures) should be implemented long term. The COVID-19 outbreak has also refocused the oncologic clinical trials community on the need to bring clinical trials closer to patients by dramatically enhancing clinical trial access, especially for minority and underserved communities that have been disproportionately affected by the pandemic. In this Commentary, changes to the program of clinical trials supported by the National Cancer Institute that could improve clinical trial availability, effectiveness, and diversity are proposed.This work was supported in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, ZIA BC 011078; Phase 0/1 Clinical Trials

Racial/ethnic differences in clinical trial enrollment, refusal rates, ineligibility, and reasons for decline among patients at sites in the National Cancer Institute's Community Cancer Centers Program

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/106705/1/cncr28483.pd

Charting the future of cancer health disparities research: A position statement from the American Association for Cancer Research, the American Cancer Society, the American Society of Clinical Oncology, and the National Cancer Institute

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/138314/1/caac21404_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/138314/2/caac21404.pd

Establishing a Primary Care Alliance for Conducting Cancer Prevention Clinical Research at Community Sites

In September 2020, the National Cancer Institute convened the first PARTNRS Workshop as an initiative to forge partnerships between oncologists, primary care professionals, and non-oncology specialists for promoting patient accrual into cancer prevention trials. This effort is aimed at bringing about more effective accrual methods to generate decisive outcomes in cancer prevention research. The workshop convened to inspire solutions to challenges encountered during the development and implementation of cancer prevention trials. Ultimately, strategies suggested for protocol development might enhance integration of these trials into community settings where a diversity of patients might be accrued. Research Bases (cancer research organizations that develop protocols) could encourage more involvement of primary care professionals, relevant prevention specialists, and patient representatives with protocol development beginning at the concept level to improve adoptability of the trials within community facilities, and consider various incentives to primary care professionals (i.e., remuneration). Principal investigators serving as liaisons for the NCORP affiliates and sub-affiliates, might produce and maintain Prevention Research Champions lists of PCPs and non-oncology specialists relevant in prevention research who can attract health professionals to consider incorporating prevention research into their practices. Finally, patient advocates and community health providers might convince patients of the benefits of trial-participation and encourage shared-decision making

Translating research into evidence-based practice: The National Cancer Institute Community Clinical Oncology Program

The recent rapid acceleration of basic science is reshaping both our clinical research system and our health care delivery system. The pace and growing volume of medical discoveries are yielding exciting new opportunities, yet we continue to face old challenges to maintain research progress and effectively translate research into practice. The National Institutes of Health and individual government programs are increasingly emphasizing research agendas involving evidence development, comparative effectiveness research among heterogeneous populations, translational research, and accelerating the translation of research into evidence-based practice, as well as building successful research networks to support these efforts. For over 25 years, the National Cancer Institute's Community Clinical Oncology Program has successfully extended research into the community and facilitated the translation of research into evidence-based practice. By describing its keys to success, this article provides practical guidance to cancer-focused provider-based research networks as well as those in other disciplines

Cancer Care Delivery Research: Building the Evidence Base to Support Practice Change in Community Oncology

Understanding how health care system structures, processes, and available resources facilitate and/or hinder the delivery of quality cancer care is imperative, especially given the rapidly changing health care landscape. The emerging field of cancer care delivery research (CCDR) focuses on how organizational structures and processes, care delivery models, financing and reimbursement, health technologies, and health care provider and patient knowledge, attitudes, and behaviors influence cancer care quality, cost, and access and ultimately the health outcomes and well-being of patients and survivors. In this article, we describe attributes of CCDR, present examples of studies that illustrate those attributes, and discuss the potential impact of CCDR in addressing disparities in care. We conclude by emphasizing the need for collaborative research that links academic and community-based settings and serves simultaneously to accelerate the translation of CCDR results into practice. The National Cancer Institute recently launched its Community Oncology Research Program, which includes a focus on this area of research

Epidemiology of community-onset Staphylococcus aureus infections in pediatric patients: an experience at a Children's Hospital in central Illinois

<p>Abstract</p> <p>Background</p> <p>The nation-wide concern over methicillin-resistant <it>Staphylococcus aureus </it>(MRSA) has prompted many clinicians to use vancomycin when approaching patients with suspected staphylococcal infections. We sought to characterize the epidemiology of community-onset <it>S. aureus </it>infections in hospitalized children to assist local clinicians in providing appropriate empiric antimicrobial therapy.</p> <p>Methods</p> <p>From January 2005–June 2008, children (0–18 years old) admitted to the Children's Hospital of Illinois with community-onset <it>S. aureus </it>infections were identified by a computer-assisted laboratory-based surveillance and medical record review.</p> <p>Results</p> <p>Of 199 patients, 67 (34%) had invasive infections, and 132 (66%) had skin and soft tissue infections (SSTIs). Among patients with invasive infections, <it>S. aureus </it>isolates were more likely to be susceptible to methicillin (MSSA 63% vs. MRSA 37%), whereas patients with SSTIs, <it>S. aureus </it>isolates were more likely to be resistant to methicillin (MRSA 64% vs. MSSA 36%). Bacteremia and musculoskeletal infections were the most common invasive infections in both groups of <it>S. aureus</it>. Pneumonia with empyema was more likely to be caused by MRSA (<it>P </it>= 0.02). The majority (~90%) of MRSA isolates were non-multidrug resistant, even in the presence of healthcare-associated risk factors.</p> <p>Conclusion</p> <p>Epidemiological data at the local level is important for antimicrobial decision-making. MSSA remains an important pathogen causing invasive community-onset <it>S. aureus </it>infections among hospitalized children. In our hospital, nafcillin in combination with vancomycin is recommended empiric therapy in critically ill patients with suspected invasive staphylococcal infections. Because up to 25% of MSSA circulating in our area are clindamycin-resistant, clindamycin should be used cautiously as empiric monotherapy in patients with suspected invasive staphylococcal infections.</p

Use of tamoxifen and raloxifene for breast cancer chemoprevention in 2010

PURPOSE: Two selective estrogen receptor modulators (SERMs), tamoxifen and raloxifene, have been shown in randomized clinical trials to reduce the risk of developing primary invasive breast cancer (IBC) in high-risk women. In 1998, the U.S. Food and Drug Administration (FDA) used these studies as a basis for approving tamoxifen for primary breast chemoprevention in both premenopausal and postmenopausal women at high risk. In 2007, the FDA approved raloxifene for primary breast cancer chemoprevention for postmenopausal women. METHODS: Data from the year 2010 National Health Interview Survey (NHIS) were analyzed to estimate the prevalence of tamoxifen and raloxifene use for chemoprevention of primary breast cancers among U.S. women. RESULTS: Prevalence of use of chemopreventive agents for primary tumors was 20,598 (95% CI, 518–114,864) for U.S. women aged 35 to 79 for tamoxifen. Prevalence was 96,890 (95% CI, 41,277–192,391) for U.S. women aged 50 to79 for raloxifene. CONCLUSION: Use of tamoxifen and raloxifene for prevention of primary breast cancers continues to be low. In 2010, women reporting medication use for breast cancer chemoprevention were primarily using the more recently FDA-approved drug raloxifene. Multiple possible explanations for the low use exist, including lack of awareness and/or concern about side effects among primary care physicians and patients