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COVID-19 immediately affected the conduct of ongoing clinical trials but it equally changed the way they will be conducted in the future, said speakers at the CEO Roundtable on Cancer online conference April 24 on “Maintaining Oncology Clinical Trial Integrity during the Covid-19 Pandemic.”
“Oncology trials represent an important subset of clinical trials,” said Dr. Mace Rothenberg, panel moderator and Chief Medical Officer, Pfizer. “There is the serious and life-threatening nature of the disease; the fact that a clinical trial may represent the best or only option for some patients with few or no other therapeutic options; they require special expertise in administration, monitoring, and management of acute adverse events or hypersensitivity reactions; and the use of advanced technology processing samples that cannot be easily performed outside of trial sites.”
There were three primary areas of discussion about trials amid the pandemic: managing patients in studies, managing data from studies, and interpreting trials with missing data and other challenges.
Speakers included clinical trial experts from industry, academia, and the US Food and Drug Administration who shared recent experiences. The audience was invited to pose questions and more than a dozen FDA staff attended the 90-minute panel to gather input and learn more about what’s happening on the front lines of research.
Within the US there have been wide geographic disparities in severity of COVID-19 and response to the virus, which makes trial operations challenging. But many shared accounts of positive results with telemedicine that will become a standard trial feature going forward.
“If there is a silver lining, it is that we are running a grand experiment concerning decentralized trials,” said Dr. Paul Kluetz, Deputy Director, Oncology Center of Excellence, FDA. “We have been interested in this for a long time, because they can show us efficiencies and can be quite patient friendly.”
Other speakers expressed frustration that regulatory agencies around the world do not agree on what trial modifications are permitted.
“Most of our recommendations at the moment have been based on internally coordinating across centers and within FDA and less of a coordination externally with the other regulatory bodies,” said Dr. Patricia Keegan, Associate Director for Policy, Oncology Center for Excellence, FDA. “That’s why I was particularly interested in comments about differences across regulatory agencies that are posing particular problems.”
Panelists agreed that some of the most pressing questions that remain include:
- How should missing trial data be handled? What statistical techniques should be used to address this?
- How do we assess the impact of geographic disparities because of the varying intensity and duration of the pandemic?
- How will we share information about tools and technologies that have been effective for remote monitoring and data collection?
- How should we view the so-called “period” effect related to the time before, during and after COVID?
- What should be site-level protocol deviations versus protocol amendments? Safety measures are being implemented without approval leading to compliance concerns.
- How do we always keep in mind the benefit to patients as well as their safety?
“We are in the middle of a grand experiment. What we don’t know yet is the result of that experiment,” Dr. Dave Reese, Executive Vice President, R&D, Amgen, said in summing up the conference. “What are the conclusions of the experiment? I believe it’s incumbent on all of us to really ask fundamental deep questions of what do we change permanently? There are many things that we must learn from this experiment.”
Most of the attendees represented pharma and biotech industries but government agencies, academia and others, including non-profits, also made up a substantial part of the audience.
Post-event surveys reflected that participants found the content important and they would likely attend a future virtual meeting hosted by the CEO Roundtable on Cancer. Discussion is ongoing about future topics for similar events.
Therese Martin represented the CEO Roundtable on Cancer at the 2019 Building Healthy Academic Communities (BHAC) Summit held on the campus of the first BIG Ten University to earn Gold Standard accreditation, The Ohio State University in Columbus, Ohio. BHAC connects health and wellness professionals from US academic institutions in pursuit of healthier campuses.
Recognizing leaders in academia are uniquely suited to influence their own institutions workforce as well as the leaders for tomorrow, Ms. Martin encouraged those in attendance to lead by example by earning Gold Standard accreditation. The message that leadership drives culture and prevention saves lives was well recieved.
More than 90 experts in the oncology community were convened on April 17, 2019, in Bethesda, Md., to focus on immune-related adverse events (irAEs) that can occur with the use of combination checkpoint blockade therapies. Co-sponsored by Project Data Sphere, LLC (PDS) and the U.S. Food and Drug Administration (FDA), this symposium focused on ways to strengthen irAE and toxicity reporting and data collection so as to better understand which patients are more likely to suffer these often-devastating adverse events. As attendees learned from a patient advocate who spoke, it is not unheard of for a patient who succumbs to an irAE to be tumor-free at the time of death.
Thought leaders organized presentations and panels on the clinical presentation of irAEs and toxicity during combination therapy, preliminary findings from immune checkpoint inhibitor (ICI) clinical trial data submitted to the FDA and post-marketing surveillance data, and current initiatives to accelerate knowledge with biorepositories and patient registries. The Symposium was distinguished by the FDA presentations of selected clinical trial data on ICIs and the post-market surveillance (FAERS) data on adverse events associated with ICIs; neither of these rich FDA data sources had ever been presented.
Now that Project Data Sphere has established itself as a world-class data-sharing platform, the group's leadership is planning for its next phase of the struggle against cancer. In this In Vivo piece, PDS President Bill Louv talks about how the organization has "raised the bar on what is possible to achieve in cancer research."
On August 8, 2018, the CEO Roundtable on Cancer-China (上海拓新健康促进中心) organized and co-hosted an all-day Tobacco Control Workshop with the Shanghai Association on Tobacco Control (SATC) under the auspices of the Office of Shanghai Health Promotion Committee. The committee were guests of the China Financial Information Center located in the world’s second tallest building, The Shanghai Tower, in the Financial District of Lujiazui.
This was the first time that all of Shanghai’s different law enforcement agencies jointly attended an open discussion on tobacco control law enforcement. Representatives from virtually every different law enforcement agency participated to including those responsible for tobacco control at Shanghai’s airports, buses and trains as well as those who oversee and conduct cultural and athletic events in this huge metropolis. It is worth noting that only rarely do municipal government and legislative officers meet together with the media.
More than 60 oncologists, data scientists, pharma/biotech industry leaders, patient advocates, health science research investigators, and regulators representing myriad esteemed institutions convened in Bethesda, Md., on August 8 for Project Data Sphere, LLC’s (PDS) sixth symposium co-sponsored with the U.S. Food and Drug Administration (FDA). With the goal of accelerating new options for small cell lung cancer patients (SCLC) in a stagnant treatment landscape, PDS is collaborating with the FDA on the development of an external control arm for SCLC clinical trials. This would enable patients to be enrolled directly into a trial’s new drug investigational arm, which ultimately would reduce the number of patients per trial as well as the cost and time of discovery for new treatment options. The daylong event featured a combination of individual and panel presentations and lively discussions
David Shepperly, MD, MHS, FACOEM, Head of Employee Health and Fitness at Bristol-Myers Squibb, invited fellow Gold Standard Task Force Member Ann Skye, BSN, MPH, Associate Director, Employee Health Management for IQVIA, to present an overview of the Gold Standard to the ORCHSE Strategies summer meeting of the Corporate Health Directors Network in Washington, DC.
Ann's overview of the unique global approach to wellness in the workplace using the framework of the CEO Cancer Gold Standard was well received. The presentation prompted a productive discussion and garnered interest in the program from meeting participants. We thank Ann and Dave for their efforts to expand the reach and impact of the Gold Standard!
ORC HSE is a membership based global HSE (Health, Safety, and Environment) networking and service firm that has been connecting HSE thought leaders across the globe for more than 45 years. The Corporate Health Directors Network serves corporate leaders with primary responsibility for occupational health program management, drawing members from the most innovative multinational Fortune 500 companies.
Senior executives of companies in Shanghai’s Lujiazui district, known as the “Wall Street of China”, pledged to create a smoke-free working environment last Wednesday. Initiated by NGO the CEO Roundtable on Cancer-China and supported by the World Health Organization, the national campaign aims to encourage as many enterprises as possible in the country to say no to smoking not only inside their offices, but also in factories, on campuses and other open spaces.
“We hope to help more employers in China to create 100 percent smoke-free workplaces, where employees are encouraged to give up smoking,” said Ray Wang, senior director of the CEO Roundtable on Cancer-China in Shanghai.
Employers can play a pivotal role in reducing cancer incidence and premature death. Healthier employees and healthier bottom lines can be achieved by providing evidence-based prevention and early detection services and encouraging employee engagement. By providing access and encouraging participation, more lives – and more money-be saved. The Gold Standard's employer-led work-place wellness model is now being shared in China and across the globe.
Ann Skye, BSN, MPH, Associate Director, Employee Health Management, IQVIA, and Global Gold Standard Subcommittee Chair, was invited by the International Association of Worksite Health Promotion (IAWHP) and the Global Center for Healthy Workplaces (GCHW) to discuss how the Gold Standard's evidence-based wellness framework can be adopted by corporations with a presence in the US, China and globally. Ann was joined by representatives from Gold Standard employers, Bristol-Myers Squibb, GlaxoSmithKline and Novartis who also shared their unique insights and perspectives.
The informative presentation and subsequent discussion focused on the challenges associated with adapting the Gold Standard requirements to a global workforce with particular emphasis on China. A recording of the webinar is available here.
Meeting the Gold Standard’s comprehensive requirements is a notable achievement. To meet the complex challenges of adopting this standard of health and wellness globally and in China takes exceptional leadership.
The CEO Roundtable on Cancer has accredited Aura Biosciences of Cambridge, MA — a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells — with the CEO Cancer Gold StandardTM recognizing its efforts to reduce the risk of cancer for its employees and covered family members.
“Our passion at Aura Biosciences is to improve treatment options for a wide range of cancers that are poorly managed today — so this recognition is very meaningful to us,” said Aura Chief Executive Officer Elisabet de los Pinos, Ph.D. “We are dedicated to creating a healthy workplace where employees have access to the highest quality medical care.”
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.
Project Data Sphere®, LLC (PDS) is proud to announce the first peer-accepted publication reporting on the multidisciplinary Immune Checkpoint Inhibitor-associated Myocarditis Workshop convened by PDS with support from the Global Oncology Big Data Alliance (GOBDA) and the Parker Institute for Cancer Immunotherapy (PICI). This Checkpoint Inhibitor Safety Working Group included leading clinicians, academic researchers, pharmaceutical companies and regulatory agencies, including the U.S. FDA, China Food and Drug Administrations (CFDA), and the European Medicines Agency (EMA). It represents the power of PDS to bring together all key stakeholders in a safe common harbor on behalf of cancer patients.
This publication in the international cancer medicine journal, The Oncologist, is the 12th peer-accepted manuscript driven by the principle of data-sharing on which PDS was founded. The manuscript, “Myocarditis Associated with Immune Checkpoint Inhibitors: An Expert Consensus on Data Gaps and a Call to Action,” by Dr. Tomas Neilan, et al., identifies a path forward in understanding, diagnosing and treating this rare but serious heart condition arising in some patients whose cancers have been treated with Immune Cancer Therapy.
On June 1, Project Data Sphere, LLC (PDS) hosted a reception at the commencement of the 2018 ASCO annual meeting in Chicago to celebrate accomplishments of the Global Oncology Big Data Alliance (GOBDA). PDS founded GOBDA as a novel strategic organization to provide opportunities for collaboration and cooperation across industry, academia and global regulatory authorities. With our founding GOBDA partner, Merck KGaA, Darmstadt, Germany / EMD Serono, this new organization is initially focused on three areas critical to improving outcomes for cancer patients:
- Rare but serious immuno-related adverse events
- Rare tumor registries
- Expanded datasets to drive new research investigations
The University of Iowa has earned the CEO Cancer Gold Standardaccreditation from the CEO Roundtable on Cancer, a nonprofit that recognizes workplaces that are exceptionally committed to reducing the risk of cancer among employees.
“As a university, our most important asset is our people,” says UI President J. Bruce Harreld. “Since innovative health care is one of the major areas of education, research, and service at the UI, we are especially proud to earn this accreditation. The health and well-being of our university community is of paramount importance to our values and to our success.”
After George Weiner, director of the Holden Comprehensive Cancer Center, secured the gold standard accreditation for UI Health Care last year, Harreld sought to ensure the university as a whole also met the accreditation requirements.
Bill Louv has been appointed President of Project Data Sphere, LLC (PDS). Bill joins PDS after working in roles of increasing responsibility at GSK – Vice President of Information Technology, Chief Information Officer and Senior Vice President of Core Business Services – where he served as a member of GSK’s Corporate Executive Management team from 2007 through 2016.
Bill’s recognized expertise in not only Information Technology, but also mastery of scientific inference as exemplified by his PhD in Statistics from the University of Florida and executive responsibilities for Global Statistics and Clinical Data Management at Marion Merrell Dow, brings a new era of insight and investigation to PDS. This era will see the wealth of cancer clinical trial data that has been aggregated, and that continues to grow, in PDS’ cancer research platform yield further meaningful and novel insights to the community of cancer researchers, physicians and patients.
With data now representing more than 121,000 patient lives leading to the publication of 11 (and increasing in number) peer-accepted manuscripts, the PDS web-based library-laboratory stands poised to deliver new discoveries to improve cancer patient outcomes, and I’m thrilled to have Bill on board to enable the research community to identify these new insights.
On October 24 near US Food and Drug Administration headquarters in Bethesda, MD, we co-hosted our fifth FDA-PDS Symposium on “Growing Dimensions of Big Data in Cancer Research.” These forums offer a unique opportunity for collaboration between often competing research entries in the world of life sciences: industry, academia and the regulatory agencies that govern them.
Propelled by recent collaborative progress such as the New England Journal of Medicine (NEJM) Project Data Sphere-inspired "Sounding Board" article, "Advantages of a Truly Open-Access Data-Sharing Model" and the issuance of a Letter of Support from Dr. Pazdur, his first as Director of the Oncology Center of Excellence, participants will provide updates and data sharing innovations from the FDA’s Oncology Center of Excellence, the Project Data Sphere initiative, and highlight other advances and opportunities in oncology treatment, research and development and regulatory science.
These Symposia also provide opportunities for open dialogue among oncology and data science leaders from academia, government, and industry, combining rich blend of expertise with a common mission of improving cancer patient outcomes. The discussion at Symposium-IV, for instance, advanced our efforts to promote innovative data-sharing in Immuno-Oncology, one of the most promising areas of contemporary oncology clinical trials.