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Initiative Updates
2021
The American Society of Clinical Oncology (ASCO) Annual Meeting (June 4-8), one of the largest scientific gatherings in cancer research, will feature several abstracts related to Project Data Sphere® research programs on External Control Arms and Immune-related Adverse Events.
External Control Arms
Of the 4,600 posters at ASCO this year, an emerging trend (more than 350 posters) is the use of real world data (RWD) and real world evidence (RWE). A landscape analysis by the FDA’s Donna Rivera and Paul Kluetz describes some of the more than 140 scenarios where RWD was presented in regulatory submissions over the past decade. (Abstract #18787: https://meetinglibrary.asco.org/record/199567/abstract)
One prominent use of RWD is as an external control or comparator arm to support claims of effectiveness where overall survival and response rate are used as primary outcomes. The primary conclusion from their analysis is the need to establish “metrics for robust data characterization and outcome validation” so that “RWD can be appropriately evaluated and provide the rigor necessary to be considered adequate RWE.”
Project Data Sphere’s External Control Arm program directly focuses on these two issues. Instead of using clinical data extracted from electronic health records, the PDS program is building external control populations from completed clinical trials and purpose-built registries. These data assets have quality components built in with clinical assessments and data entry performed under stringent protocols. We believe that this well-defined data environment will more rapidly clarify how external data assets should be developed and qualified for regulatory decision making.
Well-constructed, high quality external control arms can inform decision making throughout clinical development beginning well before regulatory engagement and be incorporated in complex innovative trial designs to: support a smaller control arm through hybrid approaches, accelerate interim analyses, and help optimize patient allocation in adaptive platform trials. [https://pubmed.ncbi.nlm.nih.gov/31155679/, https://pubmed.ncbi.nlm.nih.gov/31175098/]
PDS collaborators from Dana-Farber are presenting some of the initial findings from the GBM-INSIGhT trial, an adaptive platform trial in newly diagnosed glioblastoma.
Abstract #2006: https://meetinglibrary.asco.org/record/195931/abstract
Abstract #2014: https://meetinglibrary.asco.org/record/196561/abstract
Thirteen additional abstracts at the 2021 ASCO Annual Meeting demonstrate various uses of external control arms.
https://meetinglibrary.asco.org/results/external%20control%20arm?meeting...
In addition, patient-level data from completed clinical trials made available through the data.projectdatasphere.org portal was used in at least three posters. These studies applied deep learning to these patient-level data assets to identify candidate predictors of outcome, phenotypes of super-responders to specific therapies, and illustrate the risk of introducing bias through patient censoring.
Abstract #1549: https://meetinglibrary.asco.org/record/200166/abstract
Abstract #1548: https://meetinglibrary.asco.org/record/200113/abstract
Abstract #e13543: https://meetinglibrary.asco.org/record/200201/abstract
Immune-Related Adverse Events (irAEs)
As more cancer patients are treated with immunotherapy, benefits have been observed as well as an increase in patients experiencing neurotoxicity. There is an urgent need to understand how and why these neurologic irAEs occur, and how to best manage them.
Comprehensive knowledge of neurologic irAEs is limited and treatment guidelines are based on consensus, not evidence.
PDS irAE Task Force Co-Chairs from Massachusetts General Hospital -- Dr. Amanda Guidon and Dr. Kerry Reynolds -- as well as PDS are among the authors of an abstract on consensus definitions that were achieved for seven core disorders. The authors believe the definitions now can be used broadly across clinical and research settings.
Abstract #2647: https://meetinglibrary.asco.org/record/196134/abstract
Project Data Sphere’s open access data platform has achieved a major milestone: Boosting the impact of oncology research by contributing to publication of more than 100 peer-reviewed articles that impact research and clinical practice.
The platform aggregates patient-level trial data from biopharmaceutical companies, academic medical centers, and government organizations and makes it available with free access to SAS™ analytic tools.
“Secondary analysis of patient-level data is valuable,” said Bill Louv, President of PDS. “Analyzing the combined datasets increases statistical power to learn more about standard-of-care outcomes, rare adverse events, treatment effects in patient subsets, and reproducibility of results. That’s not possible with single datasets.”
Louv said less than 1 percent of data is reused in this manner despite the existence of multiple sites offering inventories, metadata, and controlled access to the majority of clinical trials sponsored by the pharmaceutical industry.
In the six years since it launched, the PDS platform has grown from nine datasets to more than 150 and has been accessed by more than 3,000 scientists making more than 26,000 downloads of information. The data covers more than 160,000 patient lives in clinical trials studying prostate, breast, colorectal, non-small cell lung, Merkel cell, and pancreatic cancers.
New data types are being added and they include real world data, images, and genomics information. There also is curated data, including some from RTI International that is enhanced with social, economic, and health care-related data from the national Medical Expenditure Panel Survey (MEPS). At least two publications have focused on this analytically enhanced data that enable researchers to assess the impact of socioeconomic factors on cancer survival and related outcomes.
The PDS platform is home to the world’s largest curated prostate cancer dataset, which yielded more than 25 publications in peer-reviewed journals. The Prostate Cancer DREAM Challenge, which generated the comprehensive dataset, attracted 50 international teams to help predict survival for prostate cancer patients and treatment discontinuation for those treated with docetaxel. The Challenge produced a model that accurately predicts patient outcomes that could lead to improved clinical trial design and treatment options.
Three years ago, the platform amassed enough data to build a portfolio of research programs. Those programs focus on innovative trial designs, automating lesion annotation, streamlining adverse event reporting and management of patients on immunotherapy, and multi-institutional registry-building and common data models.
The steering committee of each research program includes an observer from the FDA Oncology Center of Excellence. This activity is governed by a Public-Private Partnership between FDA and PDS. The senior sponsor of the PPP is Paul Kluetz, Associate Director of the FDA Oncology Center of Excellence.
FDA and PDS also have worked together to convene experts from academia, industry, and government to address the latest issues in oncology research. The 2021 event will be held Sept. 23 and the focus is on defining a pathway to greater reuse of trial data. Learn more here: https://www.projectdatasphere.org/events-symposia/symposium/symposium-x-.
Joya Delgado-Harris joined the CEO Roundtable on Cancer in June as Executive Director for the Gold Standard, inclusive of our Health Equity and Going4Gold initiative.
Joya previously was the Director of Research Integration for the American Cancer Society. In that role, she provided oversight and management of the integration of products and outcomes stemming from the Office of Cancer Research and Implementation into enterprise-wide mission objectives.
“Joya has tremendous experience and accomplishments in non-profit management and will be a great asset delivering on our CEO Cancer Gold Standard as we expand our reach and ambition,” said MaryLisabeth Rich, President of the CEO Roundtable on Cancer.
Past areas of work for Joya include program development, curriculum design, grant-writing, engaging board members and volunteers as well as developing business partnerships. In addition to the American Cancer Society, she has worked for Y-ME National Breast Cancer Organization, Executive Director for the Association of Village PRIDE, and Director of Product Development for the Metropolitan Atlanta Chapter of the American Red Cross.
As a breast cancer survivor, Joya serves as a Consumer Advocate Peer Reviewer for the Congressionally Directed Medical Research Programs (CDMRP), administered by the Department of Defense, sitting alongside scientists to review and evaluate innovative breast cancer research grant proposals. She also serves as a reviewer for the Cancer Prevention and Research Institute of Texas (CPRIT).
After earning a BA from Wellesley College, Joya received a Master of Public Health degree with concentration in public health policy and management from the Rollins School of Public Health of Emory University.
Adam Schechter, Chairman and CEO, Labcorp
Labcorp, headquartered in Burlington, North Carolina, has earned CEO Cancer Gold StandardTM accreditation for its work to reduce the risk of cancer for its employees and covered family members.
"We are proud to receive the CEO Cancer Gold Standard accreditation," said Adam Schechter, chairman and chief executive officer at Labcorp. "This accreditation emphasizes Labcorp’s mission to improve the health and lives of the patients we serve and of our employees and their families. We are committed to providing access to care for our employees and to incorporating programs such as those focused on cancer prevention, risk reduction and overall wellbeing."
Employers from many industries are keenly aware of the positive impact they can have on health and controlling healthcare costs when they take steps to address cancer and other chronic diseases. To earn Gold Standard accreditation, an employer must establish programs to reduce cancer risk by taking concrete actions in five key areas: emphasize prevention by prohibiting tobacco use and supporting tobacco cessation efforts; promoting physical activity, healthy nutrition and weight management; providing health insurance options that include detecting cancer at its earliest stages, ensuring access to quality care and participation in cancer clinical trials; promoting employee awareness of these initiatives; and supporting the needs of cancer survivors in the workplace.
The CEO Roundtable on Cancer Board of Directors approved updates last September to the CEO Cancer Gold Standard™, our employer-led health and well-being accreditation program. We’re excited to report these important and transformative changes have been incorporated into a new online Gold Standard application portal.
We are beginning a “Pilot Phase” to gather feedback on the new application’s user interface but we expect to broadly launch the platform later this year.
While retaining and enhancing the core tenets of prevention, early detection and quality care, the Gold Standard is being updated to have a more holistic approach to health and well-being with increased emphasis on health education, health navigation, cancer survivorship, well-being and health equity.
Further, recognizing the need to encourage aspiring Gold Standard applicants and, at the same time, challenge long time Gold Standard employers, the accreditation program and application now measures an organization’s progress on its unique health and well-being journey.
We have also been working to update our tools, resources, and processes so that we can continue to help you address the cancer burden and together save and improve lives.
If you are interested in participating this summer in the “Pilot Phase”, which will welcome feedback on the new application portal user experience, please contact Therese Martin, CEO Cancer Gold Standard’s Senior Manager, Therese.Martin@CEORoundtableonCancer.org
The CEO Roundtable on Cancer continues to partner with health-oriented organizations, like the North Carolina Business Group on Health (NCBGH), to keep members of the CEO Roundtable and our Gold Standard Community informed on the latest oncology research and it's impact on the workforce.
MaryLis Rich, President, CEO Roundtable on Cancer, recently moderated a panel as part of the NCBH Spring Forum 2021. The discussion on precision medicine explored what interventions and tests are priorities for improving health and fighting cancer.
The CEO Roundtable on Cancer has accredited BeiGene, Ltd., a global biotechnology company with the CEO Cancer Gold StandardTM recognizing its efforts to reduce the risk of cancer for its employees and covered family members.
“Our CEO Cancer Gold Standard certification demonstrates that BeiGene is a unique organization committed to improving individuals’ lives and that that commitment begins with improving the health of the company’s employees and their family members,” said Kenneth B. Lee, General Partner of Hatteras Venture Partners, LLC and Executive Chairman of the CEO Roundtable on Cancer.
“BeiGene was founded a little over a decade ago on the premise that there is an emerging opportunity to deliver high quality, innovative, impactful medicines faster and more equitably and affordably around the world,” said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. “Since then, we have worked hard to improve the health and well-being of patients, regardless of location or income, and to have a positive impact on the health of our colleagues around the world. We are proud to accept this recognition by the CEO Roundtable on Cancer, on behalf of our team of over 6,000 people and their families.”
Pandemic precautions led to a sharp decline in cancer screenings and vaccinations to prevent cancer. The CEO Roundtable on Cancer invited the Gold Standard Community to a webinar to address the screening backlog, identify those at greatest risk and address widespread missed youth vaccinations. MaryLis Rich, President, CEO Roundtable on Cancer, moderated the discussion with our distinguished panel of experts. We're grateful for the insight provided by:
- Dr. Otis Brawley is a Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University.
- Dr. Nicole Parkerson is board-certified in Pediatrics and has served as managing physician partner at Raleigh Pediatric Associates.
- Dr. K. Andrew Crighton is the former chief executive officer of the CEO Roundtable on Cancer and former Chief Medical Officer and head of the Global Health Organization for Prudential.
Resources from the presentation are available at the below links:
Strategies to Increase Vaccine Confidence (Dr. Parkerson)
Post Pandemic Well-being Communication Strategies (Dr. Crighton)
Re-accreditation for the CEO Cancer Gold Standard™ will be waived for 2021 as employers work even harder to focus on the health and well-being of their employees while also enforcing COVID-19 precautions.
This also gives us additional time to update our tools, resources and processes so we can continue to help you address the cancer burden and together create solutions for ending cancer.
Any questions should be addressed to MaryLis Rich, CEO Roundtable on Cancer President, or Therese Martin, Senior Manager.
CEO Gold Standard™ accredited companies made some positive noise on World Cancer Day on Feb. 4! Each company was mailed a Health Champion flag to raise and demonstrate their commitment to defeating cancer and building health.
There were social media posts and You Tube videos from many locations, generating lots of positive notice for you, your work and this cause. We truly were inspired and hope it made your employees as well as your community proud to see your commitment to defeating cancer and building health.
The flags are designed for flying on special opportunities throughout the year whether it’s a cancer awareness day, benefits enrollment periods, employee recruiting events, or return to work post pandemic.
Thank you again for being a Health Champion!
The CEO Roundtable on Cancer welcomes two new members to our Board of Directors: Dr. Belén Garijo, Vice Chair of the Executive Board and Deputy CEO of Merck KGaA, Darmstadt, Germany, and Dr. Peter WT Pisters, President of The University of Texas MD Anderson Cancer Center.
Dr. Garijo, a practicing physician who specialized in clinical pharmacology, has been appointed as new Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany, effective May 1. She joined the company in 2011 as Chief Operating Officer of the Biopharma business and rose to President and CEO of Healthcare in 2015.
Dr. Pisters, a renowned cancer surgeon, researcher, professor and administrator, became President of The University of Texas MD Anderson Cancer Center in 2017 after serving more than 20 years as a faculty member and medical director for the center’s expansion in metropolitan Houston. Prior to that, he served as President and CEO of the University Health Network in Toronto, Canada’s largest academic medical center.
“Doctors Belén Garijo and Peter Pisters share a passion for fighting cancer and their insights will be invaluable in our ongoing quest to eliminate this terrible disease,” said Robert Bradway, CEO Roundtable on Cancer Chairman and Amgen CEO.
Brian Alexander, MD, MPH
Brian Alexander, M.D., M.P.H., succeeds Cindy Perettie as chief executive officer of Foundation Medicine, Inc., a member of the CEO Roundtable on Cancer and a Gold Standard accredited employer.
Previously Dr. Alexander was Foundation Medicine’s chief medical officer since 2019. He brings years of experience as a radiation oncologist at Dana-Farber/Brigham and Women’s Cancer Center and an Associate Professor at Harvard Medical School.
As of April 6, Cindy Perettie has taken on a new role within Roche Diagnostics.
Dr. Alexander has directed Foundation Medicine’s decision insights strategy to help more oncologists, both in community and academic settings, determine the right treatment, at the right time, for each unique patient. He also served as a White House fellow and Special Assistant to the Secretary of Veterans Affairs, where he helped prepare the VA for the transition of administrations, worked to develop a public reporting system for quality, and served as a health policy advisor to the Secretary.
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials.
The CEO Roundtable welcomes as a new member GRAIL, Inc., a healthcare company whose mission is to detect cancer early, and Chief Executive Officer Hans Bishop, who has more than 30 years of experience in the biotechnology industry.
Bishop founded Juno Therapeutics in 2013 and served as its President and Chief Executive Officer until the company was acquired by Celgene in March of 2018. Prior to this, he served as an Executive in Residence at Warburg Pincus. Earlier in his career, he was the Executive Vice President and Chief Operating Officer for Dendreon, Inc. He also previously served as President of Specialty Medicine at Bayer Healthcare, Senior Vice President of Global Commercial Operations at Chiron Corporation, and Vice President and General Manager of European Biopharmaceuticals. He currently serves as the Executive Chair of the Sana Board of Directors and as a Director of Agilent Technologies and Lyell Immunopharma. Hans holds a BA in chemistry from Brunel University in London.
GRAIL is focused on saving lives and improving health by pioneering new technologies for early cancer detection. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges with its multi-cancer early detection blood test.
With this proprietary technology, GRAIL is also developing solutions to help accelerate cancer diagnoses, blood-based detection for minimal residual disease, and other post-diagnostic applications.
GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
Ron Z. Goetzel, PhD
Businesses that promote employee health, like the more than 200 CEO Cancer Gold Standard™ accredited employers, are being urged to support public health beyond their own employees by a new report prepared by the Johns Hopkins Institute for Health and Productivity Studies (IHPS).
Recommendations from the report, Seven Ways Businesses Can Align with Public Health for Bold Action and Innovation, offer strategies to end and recover from the COVID-19 pandemic and ensure America is better prepared to address future public health crises.
“A large-scale effort to address our public health vulnerabilities will require business and public health leaders, as well as policymakers, to join forces in support of healthier employees and communities—the key to a more resilient workforce and a strong economy,” said Ron Goetzel, PhD, Director of IHPS and a member of the Gold Standard Steering Committee.
These are the seven recommendations in the report funded by the de Beaumont Foundation for business leaders. They are:
- “Put out the fire” of COVID-19 by following advice of credible public health experts.
- Improve the health and well-being of employees.
- Promote healthy communities.
- Become a “force Multiplier” by leveraging expertise, staff, and other resources to collaborate with local and state public health departments to be better prepared for future public health emergencies.
- Actively facilitate public-private partnerships in the community.
- Advocate for development of accountability dashboards that track and monitor progress toward achieving key economic and public health outcomes in a community.
- Advocate for rebuilding and expanding a national public health workforce supported by a modern information technology infrastructure.
Project Data Sphere kicked off 2021 with exciting news: We have completely revamped our Data Sharing Platform. It’s the largest update and enhancement since PDS originally launched more than 6 years ago.
What does this mean for you?
- It’s easier to find data and gain perspective around what is included within each study or contribution.
- Along with improved navigation, we have integrated content from clinicaltrials.gov so you have visibility to additional metadata.
- If you are interested in finding any data curations or what we consider linked-data, such as the AHRQs Medical Expenditure Panel Survey data, it’s incredibly easy to find through new filter options.
- You will also notice that the process for contributing data is greatly improved.
Thanks go to our active user community (now over 3,000 registered) for making this platform what it is today. We are listening and striving to maximize data reuse, advance oncology research, and serve our patient population.
Feedback has been gratifying. A user from the University of North Carolina with a newly accepted publication said, “Thank you for building this amazing platform so we could use the data to tackle real problems.”
The trust and engagement by data-sharing partners remain a critical piece of the platform. A big shoutout to Merck KGaA (EMD Serono), Eli Lilly, and G1 Therapeutics for their recent contributions across Glioblastoma, Pancreatic Cancer, Small Cell Lung Cancer, and Non-Small Cell Lung Cancer.
Every data contribution counts, and Project Data Sphere is committed to advocating on behalf of all patients participating in clinical trials by driving greater reuse of their individual data. Our laser focus for 2021 is ‘Data Reuse’ through stronger positioning of our sharing platform and analytics space, active research programs, and by establishing key partnerships to drive progress.
We have been working hard to plan an upcoming virtual symposium on this topic so mark your calendar for September 23 and join to hear how effective reuse of clinical trial data can lead to faster approvals and gain insights around how you can contribute to this critical ecosystem.