Much has been written of late about the potentially transformative impact of Big Data – by which people usually mean massive amounts of clinical, genomic, demographic and transactional information that is way too large to handle with traditional information technology. Such impact seems to be centered, however, on Big IT companies helping Big Provider organizations in ways that are not visible to us, and seem to have no relevance to our lives as patients so far.
So, is there a role for each of us in Big Data, and what could it mean to us as stakeholders who deeply care about innovation as the pathway to more productive cancer research and more effective cancer care?
Emphatically, yes. The aggregation and usage of Big Data could, in fact, be the catalyst we’ve been seeking for a long time, making individual patients the ‘center of gravity’ in healthcare. But, to make that happen, I believe each of us has to be pro-active, in the following ways:
There is strength in numbers. We, as consumers and as patients, are ‘big’. And with our involvement, Big Data can have big results for cancer innovation.
Marcia A. Kean, MBA, has built Feinstein Kean Healthcare’s unique national role in the life sciences since the firm’s inception more than twenty five years ago. She served as the Chief Executive Officer of the firm from 2002 to 2011, and became Chairman, Strategic Initiatives in 2011. Marcia has more than 35 years of biomedical and information technology industry experience. She has business operating experience inside commercial and non-profit organizations, as well as knowledge of the development and implementation of public-private projects undertaken by multi-stakeholder ecosystems. In 2003, Marcia founded the first Molecular Medicine communications practice in the country. She led the communications activities on behalf of the National Cancer Institute’s first-generation bioinformatics program for seven years. Marcia has served as an advisor to the Personalized Medicine Coalition (PMC) since its inception, and as a member of the Planning Committee of the Harvard Personalized Medicine Conference since 2004. She has served as a member of the Evidence Communication Innovation Collaborative of the Institute of Medicine since 2008. She served as co-Vice Chair of the Advisory Committee of the Institute of Medicine’s Cancer Informatics Workshop in February 2012; subsequently, she founded the Data Liquidity Coalition to address the challenges of biomedical data exchange. She chaired the Advisory Committee of “Turning the Tide Against Cancer Through Sustained Medical Innovation”, a national conference on science and policy, co-hosted in June 2012 by the Personalized Medicine Coalition, American Association for Cancer Research, and Feinstein Kean Healthcare. She serves as a member of Life Sciences Research Program Advisory Group of Internet2, and provides input to the Health Data Consortium on policy initiatives and building an ecosystem comprised of multiple constituencies. Marcia holds an M.B.A. in finance from New York University and a B.A. from the University of California at Berkeley.
We are now in an era of incredible scientific progress, where our understanding of the molecular underpinnings of disease enables scientists and researchers to develop treatments that are more targeted and precise in their impact. As highlighted in a blog post by Dr. Raju Kucherlapati from Harvard, oncology is at the leading edge of advances in personalized medicine, offering patients better options that deliver improved health outcomes.
As we are able to better tailor treatment plans for cancer patients, it’s important to take into consideration not only the patient’s particular diagnosis given the heterogeneity of this disease, but also account for other patient comorbidities while seeking to improve the particular outcomes that matter to each patient. Whether patients prioritize extended life or quality of life, each patient must make a treatment decision with their doctor, based on their unique situation and preference.
The ongoing debate over cost and value is an important one, yet we are hampered by traditional tools for determining the value of new medicines and medical technologies, which typically rely on point-in-time assessments of product value and the average impact that a product has over a population. This means that such tools frequently fail to reflect important differences in individual patient needs, and evolving evidence about the benefits and potential uses of new treatments.
Given the challenges of assessing product value it is important not to use value assessment to drive choice of treatment in a way that would limit innovation and patient access to personalized treatment. For example, payment models which give providers a narrowly targeted cost incentive, such as episode-based payments, risk both hampering patient access to appropriately customized treatment and limiting future innovation.
It’s essential for payment reforms to include mechanisms to encourage adoption of technological advances, recognize the value of innovation over time, and incentivize high quality performance on robust measures of clinical and patient reported outcomes. In addition, instead of attempting to define narrow, static care episodes that fail to account for medical advances, payment reforms should focus on empowering patients and providers with timely, accurate information on the range of treatment options, and advancing patient-centered care through models such as medical homes and accountable care organizations that give providers incentives to help patients navigate the care continuum in a way that meets their needs and improves efficiency.
Randy Burkholder is Vice President of Policy and Research at the Pharmaceutical Research and Manufacturers of America. Mr. Burkholder leads PhRMA work on policy solutions for supporting continued biopharmaceutical innovation and high-quality, patient-centered health care, including issues involving comparative effectiveness research, health technology assessment, payment and delivery reform (accountable care organizations and bundled payment policy), appropriate use and patient adherence, and personalized medicine. Mr. Burkholder represents PhRMA at federal agencies and advisory bodies including the Medicare Evidence Development and Coverage Advisory Committee, CMS’ Technical Expert Panel on oncology, and the Federal Coordinating Council for Comparative Effectiveness Research. He also is a former member of the Board of Directors of the Personalized Medicine Coalition and serves on the Steering Committee of the Partnership to Improve Patient Care and the advisory committee for the Turning the Tide Against Cancer initiative.
Mr. Burkholder has over 17 years experience in health care policy, advocacy and communications in the medical technology and pharmaceutical industries.
Prior to joining PhRMA, Mr. Burkholder was Associate Vice President for Public Affairs at AdvaMed, the leading association of the medical device and diagnostics industries.
Over the past few decades, we have made significant progress against many forms of cancer. Today, there are nearly 14 million cancer survivors living in the United States, 15 percent of whom were diagnosed 20 or more years ago. There have also been more than 1 million fewer cancer deaths since the early 1990s as a result of declining death rates from cancer.
However, in spite of the progress, cancer, which is a collective term to describe more than 200 different diseases, remains the second most common cause of disease-related death in the U.S., according to the AACR Cancer Progress Report 2013.
The American Association for Cancer Research (AACR) supports the need for ongoing research and the translation of scientific discoveries into new and better ways to prevent, detect, diagnose, and treat cancer. To this end, we have partnered with the Personalized Medicine Coalition (PMC) and Feinstein Kean Healthcare (FKH) on the “Turning the Tide Against Cancer Through Sustained Medical Innovation” initiative with the goal of fostering a national dialogue on how to sustain innovation in cancer research and care in an environment of intense pressure to contain rising health care costs.
A recent article published in Clinical Cancer Research and authored by members of the initiative’s advisory committee, examines the themes that have emerged from these discussions. A key issue has been the need to support the development of patient-centered cancer research and care.
Patient engagement in research is critical to developing high-value cancer care that addresses issues that are most important to patients and their care givers. Researchers and policy makers are grappling with questions such as: How do we identify the research questions that are most responsive to the needs of patients and their caregivers? How can patients become meaningfully involved in research? How do we support the communication of research findings to enable improved patient decision support? How do we ensure that health care policies and incentive structures are aligned with the goal of providing high-quality patient-centered care?
This fall, AACR, PMC, and FKH will convene a national conference in Washington, D.C., to explore specific policy solutions for these and other questions with the goal of delivering on the promise of cancer research to patients. We look forward to continuing this dialogue.
Dr. Margaret Foti is the chief executive officer of the American Association for Cancer Research (AACR). The AACR is the world’s oldest and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. Under her visionary leadership, its membership has grown to over 34,000 laboratory, translational, and clinical researchers; population scientists; other health care professionals; and cancer advocates in more than 90 countries.
She is a graduate of Temple University’s School of Communication and Journalism, and is an influential voice in advancing the field of cancer research in the United States and abroad. She was elected president of three professional societies in scholarly publishing and in cancer research. She has also served as a board member, committee member, consultant and advisor to a variety of nonprofit cancer organizations. Dr. Foti routinely serves as a key advisor to AACR’s Program Planning Committees where she guides their development of over 6,500 presentations for our annual meetings. She supports and oversees the administration of AACR’s Councils with a legacy of fellows, women, and minority scientists whose careers have been advanced as a result of her mentorship and support.
Dr. Foti’s contributions to the cancer field have been widely recognized by awards from organizations and institutions around the world. Her lengthy list of formal recognitions includes honorary degrees in medicine and surgery from three universities in Italy and Spain.
Under Dr. Foti’s leadership, the AACR has served with distinction as the scientific partner of StandUp To Cancer (SU2C). In this capacity, Dr. Foti and the AACR have brought extraordinary expertise and dynamism to their SU2C work with special emphasis in expert peer review, grant administration, and scientific oversight of team science and individual grants in cancer research that have the potential for near-term patient benefit.
As CEO, Dr. Foti serves as the lead representative to AACR’s ACCME programs and activities in continuing medical education for live events, journal education, and manuscript review. She provides guidance on its programs, presenters, and chairpersons.
Among her most recent awards and presentations:
March 2014, Morton M. Kligerman Professorship Award recognizing outstanding contributions to the discipline of oncology, particularly in the area of research.
January 2014, Distinguished Grand Rounds Lecture, UT M. D. Anderson Cancer Center, Houston, TX entitled, “Reflections on the Cancer Research Landscape: Where Do We Go From Here.”
November 2013, Invited Speaker at 22nd Asian Pacific Cancer Conference, Tianjin, Republic of China entitled, “Global Progress Against Cancer, Challenges & Opportunities.”
June 2013, Invited Keynote Speaker to give Mildred Scheel Distinguished Lecture, entitled, “AACR and Its Leadership Role in the Conquest of Cancer," German Cancer Research Center, Heidelberg, Germany.
May 2013, Stanley P. Reimann Award for deep and far-reaching contributions to cancer service and medicine from Fox Chase Cancer Center, Philadelphia, PA.
Perhaps the most compelling, as well as the least understood of the evolving models for cancer research and care is patient-centered research and care. As a cancer survivor and long-time advocate, I am often asked to provide the patient perspective in the various venues where patient-centered issues are discussed.
In these venues, the patient is often portrayed, and viewed, as a two-dimensional figure—a flat, faceless cutout at the center of a diagram. Yet, as we all know, patients are multi-dimensional people with diverse values, experiences, and desires who are members of a greater community. We are more than our diagnosis and our life is comprised of much more than our disease.
It is only possible to conduct true patient-centered research and to achieve true patient-centered care when the patient is known. To develop this knowledge, we need to understand both the individual and the greater community of which she is a part. We must engage patient voices in open, transparent discussions about issues that are important to them personally, as well as to consider these issues’ impact on society. We must understand how personal and community values inform conversations about value and how we look at the cost of treatment and the continuum of hope, risk and benefit.
The Cancer Support Community established the Cancer Experience Registry to track the immediate, ongoing and changing social and emotional experience of cancer survivors. The registry reaches survivors across the country and engages them to share their voices about issues that matter to them. Through the registry, we garner, analyze and disseminate insights and knowledge in order to positively impact each individual’s cancer experience; we aim to help the nation’s health care systems to be more responsive to the needs of cancer survivors; and to accelerate and enhance the productivity of research to improve quality outcomes.
Value, as defined in the context of cancer research and care, is typically a measure of outcome (overall survival) and cost. Often, this formula does not reflect how patients define value. We asked participants in CSC’s Cancer Experience Registry to define value in the context of their cancer experience. Below are a few representative responses.
An understanding of the many ways in which patients define value and of the varied lenses through which they make decisions are critical to true patient-centered research and care. Bringing patient voices to the forefront through a patient powered-research model will help create a truly meaningful patient-centered system.
Gwen Darien is Executive Vice President of Programs and Services where she oversees research, programs, education, and patient and family services.
Prior to joining CSC, Gwen was a director of The Pathways Project—an organization that puts people at the center of health care research and delivery. She served as executive director of the Samuel Waxman Cancer Research Foundation. In this role, she was committed to developing collaborations across all segments of the cancer community to translate research discoveries from the bench to the bedside.
Prior to joining SWCRF, Gwen was editor-in-chief of CR magazine and director of the American Association for Cancer Research Survivor and Patient Advocacy Program where she led initiatives to foster mutually beneficial and enduring partnerships among cancer survivor, patient advocacy and scientific communities through collaborations, communications and education. CR magazine was launched under Darien’s leadership in March 2006 to serve an unmet need: a forum for sharing credible, balanced information about life with cancer and perspectives on the pressing challenges in cancer research today.
Gwen was previously the editor-in-chief of MAMM, a consumer magazine dedicated to women with breast and reproductive cancer. During Darien's tenure, MAMM won international acclaim for its coverage of survivorship, health disparities, controversies in women's cancers and health care policy.
Gwen has addressed cancer survivors and scientists across the country and in Europe at many panels, workshops and conferences. Gwen is a member of the Steering Committee of the Data Liquidity Coalition and the program committee of the Accelerating Anti-Cancer Agent Development and Validation Workshop. She served as Chair of the NCI Director’s Consumer Liaison, the Secretary’s Advisory Committee on Health, Genetics and Society and the advisory board of Center for Patient Partnerships at the University of Wisconsin and the Health Advocacy Program at Sarah Lawrence College.