Laura A. Levit

Patient‐centered, evidence‐based, and cost‐conscious cancer care across the continuum: Translating the Institute of Medicine report into clinical practice

In 2013, the Institute of Medicine (IOM) concluded that cancer care in the United States is in crisis. Patients and their families are not receiving the information that they need to make informed decisions about their cancer care. Many patients do not have access to palliative care and too few are referred to hospice at the appropriate point in their disease trajectory. Simultaneously, there is a growing demand for cancer care with increases in new cancer diagnoses and the number of patients surviving cancer. Furthermore, there is a workforce shortage to care for this growing and elderly population. The IOMs report, Delivering High‐Quality Cancer Care: Charting a New Course for a System in Crisis, outlined recommendations to improve the quality of cancer care. This article provides an overview of the IOM report and highlights the recommendations that are most relevant to practicing clinicians who care for patients with cancer across the continuum. The implementation of the recommendations in clinical practice will require better patient‐clinician communication, improved care coordination, targeted clinician training, effective dissemination of evidence‐based guidelines and strategies for eliminating waste, and continuous quality assessment and improvement efforts. CA Cancer J Clin 2014;64:408–421.

Untapped Potential of Observational Research to Inform Clinical Decision Making: American Society of Clinical Oncology Research Statement

ASCO believes that high-quality observational studies can advance evidence-based practice for cancer care and are complementary to randomized controlled trials (RCTs). Observational studies can generate hypotheses by evaluating novel exposures or biomarkers and by revealing patterns of care and relationships that might not otherwise be discovered. Researchers can then test these hypotheses in RCTs. Observational studies can also answer or inform questions that either have not been or cannot be answered by RCTs. In addition, observational studies can be used for postmarketing surveillance of new cancer treatments, particularly in vulnerable populations. The incorporation of observational research as part of clinical decision making is consistent with the position of many leading institutions. ASCO identified five overarching recommendations to enhance the role of observational research in clinical decision making: (1) improve the quality of electronic health data available for research, (2) improve interoperability and the exchange of electronic health information, (3) ensure the use of rigorous observational research methodologies, (4) promote transparent reporting of observational research studies, and (5) protect patient privacy.

Addressing Administrative and Regulatory Burden in Cancer Clinical Trials: Summary of a Stakeholder Survey and Workshop Hosted by the American Society of Clinical Oncology and the Association of American Cancer Institutes

Cancer clinical trials are responsible for many of the recent advances in oncology care, including declining mortality rates and increased survivorship; better supportive care; and clinicians’ improved understanding of cancer risk, prevention, and screening. This research has also led to exciting new types of cancer treatments, such as molecularly targeted therapies and immunotherapies. Cancer clinical trials, however, have become more and more challenging to conduct. Research programs must comply with federal and state legal and regulatory requirements that can be inefficient and costly to implement. In addition, institutions and sponsors often interpret these requirements conservatively and thereby add to the complexity and perceived (but often highly theoretical) risk of conducting clinical trials. Elements of the existing requirements are important for protecting trial participants’ safety, for promoting the scientific integrity of research, and for ensuring that trial conduct is efficient and adequately resourced. Such elements are important to preserve. However, taken as a whole, the requirements do not fulfill these goals and, in fact, hinder research and slow patients’ access to safe and effective treatments. To address the problem of administrative and regulatory burden on cancer clinical trials, ASCO partnered with the Association of American Cancer Institutes (AACI) on the Best Practices in Cancer Clinical Trials Initiative (hereafter referred to as the Initiative). ASCO is the leading professional organization to represent oncologists and other health care professionals who care for people with cancer and conduct research to improve cancer treatment. With . 40,000 members, ASCO is committed to the improvement of cancer care through scientific meetings, educational programs, defining and measuring the quality of cancer care, and publishing peerreviewed journals. AACI represents 95 leading cancer research centers in North America. Its mission is to assist cancer centers in keeping pace with the changing landscape of science, technology, and health care through the dissemination of best practices, creation of member forums, and development of policy recommendations and educational material. The purpose of the Initiative was to promote practical solutions to meet existing regulatory and administrative requirements on research. Both ASCO and AACI have previously explored various strategies to streamline the conduct of clinical trials, such as the development of supportive tools and templates, networking sessions, and common guidelines and standards. The Initiative was an opportunity to expand on their current work in this area. A multidisciplinary working group of hematologists/oncologists, research nurses, administrators, and managers as well as industry representatives oversaw the Initiative. Officials from the Food and Drug Administration (FDA) and the National Cancer Institute (NCI), contract research organization (CRO) staff, and patient advocates provided input to the project. The main elements of the project included a stakeholder survey to identify the most pressing issues in clinical trials that could be addressed by the Initiative, assess staff and resources for conducting and managing trials, and gather data on usage of existing tools and resources; an invitational workshop that convened many leading oncology professionals and policymakers to identify potential solutions for improving the efficiency and conduct of cancer clinical trials; dissemination of the recommendations from the workshop through publication and ASCO and AACI annual meetings; and the development of practical resources, toolkits, and follow-up Julie M. Vose, University of Nebraska, Omaha, NE; Laura A. Levit, Patricia Hurley, and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; Carrie Lee, University of North Carolina at Chapel Hill, Chapel Hill, NC; Michael A. Thompson, Aurora Health Care, Milwaukee, WI; Teresa Stewart, New Mexico Cancer Care Alliance, Albuquerque, NM; Janie Hofacker, Association of American Cancer Institutes, Pittsburgh, PA; and Daniel F. Hayes, University of Michigan, Ann Arbor, MI.

Reaffirming and Clarifying the American Society of Clinical Oncology’s Policy Statement on the Critical Role of Phase I Trials in Cancer Research and Treatment

Jeffrey S. Weber, New York University Langone Medical Center, New York, NY Laura A. Levit, American Society of Clinical Oncology, Alexandria, VA Peter C. Adamson, The Children’s Hospital of Philadelphia, Philadelphia, PA Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA Howard A. Burris, Sarah Cannon Research Institute, Nashville, TN Michael A. Carducci, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD Adam P. Dicker, Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA Mithat Gönen, Memorial Sloan Kettering Cancer Center, New York, NY Stephen M. Keefe, University of Pennsylvania, Philadelphia, PA Michael A. Postow, Memorial Sloan Kettering Cancer Center, New York, NY Michael A. Thompson, Aurora Health Care, Milwaukee, WI David M. Waterhouse, Oncology Hematology Care, Cincinnati, OH Susan L. Weiner, Children’s Cause for Cancer Advocacy, Washington, DC Lynn M. Schuchter, University of Pennsylvania, Philadelphia, PA

Expanding the Evidence Base in Geriatric Oncology: Action Items From an FDA-ASCO Workshop

As part of the ongoing efforts to address the lack of clinical research on older adults with cancer, the American Society of Clinical Oncology (ASCO) and the US Food and Drug Administration cosponsored a public workshop on geriatric oncology in November 2017. The goals were to review progress, build collaborations across stakeholders, and generate new action items for increasing the evidence base for treating older adults with cancer. It built on previous work of the Institute of Medicine, ASCO, and the U13 Conferences convened by the Cancer and Aging Research Group, the National Cancer Institute, and the National Institute of Aging between 2010 and 2015. The workshop drew a diverse group of presenters, panelists, and attendees, including academic and clinical oncologists, regulators, other government officials, representatives from industry, and patient advocacy groups. Attendees at the workshop were tasked with proposing next steps to address the lack of evidence on treating older adults with cancer. Based on the workshop discussions, four new action items to move the field forward were developed: 1) increase enrollment of older adults in clinical trials, 2) collect more information on older adults enrolled on clinical trials, 3) expand the use of real-world data in research on older adults, and 4) strengthen collaboration between stakeholders to develop advocacy and policy solutions. These action items, alongside the previous ASCO, Institute of Medicine, and U13 recommendations, provide a strategy for improving the evidence base for treating older adults with cancer and ensuring all patients with cancer receive high-quality, evidence-based care.

Trial Reporting in Immuno-Oncology (TRIO): an American society of clinical oncology-society for immunotherapy of cancer statement

PurposeTo develop recommendations for clinical trial reporting that address the unique efficacy, toxicity, and combination and sequencing aspects of immuno-oncology (IO) treatments.MethodsASCO and the Society for Immunotherapy of Cancer (SITC) convened a working group that consisted of practicing medical oncologists, immunologists, clinical researchers, biostatisticians, and representatives from industry and government to develop Trial Reporting in Immuno-Oncology (TRIO) recommendations. These recommendations are based on expert consensus, given that existing data to support evidence-based recommendations are limited.ConclusionThe TRIO recommendations are intended to improve the reporting of IO clinical trials and thus provide more complete evidence on the relative benefits and risks of an IO therapeutic approach. Given the rapid expansion of the number of IO clinical trials and ongoing improvements to the evidence base supporting the use of IO treatments in clinical care, these recommendations will likely need regular revision as the IO field develops.