Recently, the Conference Forum presented Clinical Research as a Care Option, which was chaired by Katherine Vandebelt, Formerly, Global Head, Clinical Innovation, Eli Lilly and Jeff James, CEO, Wilmington Health. So we were thrilled to see that Dr David Schenkein, CEO, Agios Pharma, who keynoted in 2015 at the Chief Medical Officer Summit recently published […]
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June 12, 2017
CMO Speaker, Dr David Schenkein Writes About Bringing Clinical Trials to Patients
Recently, the Conference Forum presented Clinical Research as a Care Option, which was chaired by Katherine Vandebelt, Formerly, Global Head, Clinical Innovation, Eli Lilly and Jeff James, CEO, Wilmington Health. So we were thrilled to see that Dr David Schenkein, CEO, Agios Pharma, who keynoted in 2015 at the Chief Medical Officer Summit recently published on Linkedin his view on the topic of bringing trials closer to patients. See below:
To Get Patients into Clinical Trials, We Need to Get Clinical Trials to Patients
The other day, an Agios employee, Holly, took an Uber to make a midday meeting. The driver mentioned that he was from out of town and welcomed any shortcuts to get to their destination. She asked where he was from, and during her brief ride, she learned that he drove an elderly woman from New Hampshire to Boston twice a week so she could participate in a clinical trial for a new cancer treatment at Mass General Hospital. It was a two-hour trip each way, and the treatment took four hours, so he filled that time giving rides close to the hospital.
For the rest of the day, this woman’s story clung with Holly, who found herself wondering if she had friends or family with her at the hospital, what investigational medicine she was taking and if it made her sick on the long drive home. When Holly shared her experience with me, despite the pangs of sympathy, I found solace in the fact that this woman lives within driving distance of one of the leading cancer centers in the U.S., giving her access to the most advanced cancer care and potentially lifesaving clinical trials.
Though the time commitment is significant and the cost of transportation is likely high, her situation is a stark contrast to the estimated 85 percent of cancer patients around the country who receive care in a community setting, where clinical trials are less likely to be offered. I’ve written before about my own experiences with the harsh emotional reality of participating in studies of new treatments, but low enrollment can also be attributed to geography. The truth is, most patients don’t live near a hospital or academic center that offers clinical trials, which can often be life-saving options for people who have already received approved therapies. Recent studies suggest that outcomes can vary widely depending on where patients receive care.
There are many factors driving the inequities between cancer care and clinical trial access at academic health centers vs. community hospitals – including infrastructure costs, required FDA guidelines for clinical trials, necessary staff support, etc. Bridging that divide is something a colleague and friend of mine, Keith Flaherty, M.D., has spent much of his career trying to address. Dr. Flaherty is the Director of Developmental Therapeutics Clinical Research at the Massachusetts General Hospital Cancer Center and professor of medicine at Harvard Medical School. He also serves as the principal investigator for a clinical trial called NCI-MATCH, which is a study launched in August 2015 that analyzes patients’ tumors to determine whether they contain gene abnormalities for which a targeted drug exists and assigns treatment based on the abnormality. This study brings genomic testing and access to 30 targeted therapies to 6,000 patients at hundreds of hospitals and more than 1000 healthcare locations across the U.S. at no cost to the patient or treatment center.
I spoke with Dr. Flaherty a few weeks ago to get his perspective on NCI-MATCH and the future of clinical trial access outside of big research centers. Here’s what he had to say.
What does the future look like for clinical trials over the next few years?
It’s suffice to say there’s a big gap and a big unmet need, and we must figure out how to move forward given that NCI-MATCH is about to end and a large clinical investigation community is going to lose access to genetic testing and clinical trial options. I recently co-founded a company called Strata Oncology, which aims to potentially perform an NCI-MATCH-like function. We’re focusing on driving clinical trial participation in regional networks outside of academic medical centers, which allows patients to stay in their community and creates a much more efficient process for matching them to clinical trials of targeted therapies.
Certainly this addresses one of the bigger issues of identifying patients for biomarker-driven studies, which is critical. How has NCI-MATCH created the infrastructure in smaller community settings to make it easier to put a patient on a study and/or get a sponsor to use a small hospital that may only bring in one or two patients?
Providing small hospitals with the genomic tests to identify biomarkers is pretty straightforward and a good place to start. Creating the necessary clinical trial infrastructure piece is doable. It just requires stripping out some of the bells and whistles. Part of this is reducing the amount of data that these hospitals are required to collect for trials. With fewer resources, community centers can only do so much, so studies have to be structured in a way that allows them to capture registration-quality data, which isn’t feasible if they’re being asked for 1,000 data points per patient.
As you look ahead of the next 5 years, in terms of a change to the model and how we conduct clinical trials, do you believe we’ll see more biomarker-driven trials being offered in communities?
I do believe that some version of democratizing clinical trial access will happen. I think it has to start with a coalition of sponsors who are looking for sparsely distributed, genetically defined patients in order to make it reasonably efficient. Together, we need to figure out a geographically smart way to get these clinical trials to where patients are, and streamline what we’re asking for in these community settings. This could easily double the percentage of patients who enroll in trials nationwide.
For the benefit of the millions of people with cancer who are or will be treated in a community hospital, I hope Dr. Flaherty is right.
April 5, 2017
Clinical Research as a Care Option (CRAACO) Recap
The Conference Forum presented an afternoon program on April 4th dedicated to Clinical Research as a Care Option (CRAACO). How can CRAACO become a reality? To find out, let’s take a look at the highlights from CRAACO: Keynote Speaker Panel Explores Bridging Healthcare to Life Science The CRAACO portion of the CTC conference launched with […]
The Conference Forum presented an afternoon program on April 4th dedicated to Clinical Research as a Care Option (CRAACO).
How can CRAACO become a reality? To find out, let’s take a look at the highlights from CRAACO:
- Keynote Speaker Panel Explores Bridging Healthcare to Life Science
The CRAACO portion of the CTC conference launched with a keynote speaker discussion about how to bridge healthcare to life science.
Panel discussion participants included:
Jennifer Byrne, Founder, Greater Gift Initiative
John McConnell, MD, CEO, Wake Forest University Medical Center
Tom Pike, Life Science Advisor, Former CEO, Quintiles
According to McConnell, it is paramount for healthcare organizations to think about all aspects of the healthcare system relative to CRAACO. By doing so, these organizations can identify clinical trial problems and address such issues before they escalate.
“We need to think about making that whole system of clinical trials as a care option work,” McConnell said.
In addition, effective data management and education are key tenets to link healthcare to life science, McConnell stated.
“We need more data,” he noted. “More education and support are needed to make clinical trial a valuable experience for organizations and patients.”
- Healthcare Experts Discuss Accountable Care Organization (ACO) and Clinical Research As a Counter Measure
Healthcare is shifting toward a value-based system where quality, cost and experience are transparent to the patient. As such, the link between clinical research and population health and value is becoming increasingly important to healthcare organizations and patients alike.
Several healthcare leaders discussed how organizations are using clinical research in conjunction with their ACO to drive value during a CRAACO panel discussion that featured insights from:
Jeff James, CEO, Wilmington Health
Kenneth Bilger, CEO, Christie Clinic
Robert Matthews, President and CEO, Medisync
Matthews defined value as “the amount a group is paid for medical services and/or number of patients that can be gained with access to care.” He also indicated the value-payment model offers enhanced measurement and transparency – both of which are exceedingly valuable for patients and healthcare organizations.
Data may transform the way that healthcare organizations analyze value as well, Matthews stated. If healthcare organizations embrace data management and discover ways to get doctors to engage on data, these organizations may be able to optimize the value of their clinical research efforts.
- Leadership Panels Analyzes Value-Based Healthcare Delivery
What is value-based healthcare, and how can it help deliver improved patient outcomes? Healthcare experts explored these topics as part of a CRAACO panel discussion that included insights from:
Meredith Alger, Healthcare Researcher, Program Manager, Harvard Business School
Christina Akerman, MD, President, International Consortium of Health Outcome Measurements (ICHOM)
Toyin Okanlawon, MD, Senior Researcher, Harvard Business School, Institute for Strategy & Competitiveness
How value-based healthcare can be delivered often is debated, according to Okanlawon. But healthcare organizations cannot debate the importance of healthcare quality and the accountability factors associated with it.
“Value is not synonymous with quality,” Okanlawon said. “Value embeds itself with accountability. … At the end of the day, we’re all going to disagree on how to measure costs. But we can’t really disagree on whether someone is dead or alive.”
Furthermore, healthcare organizations must prioritize value-based outcomes over costs, Akerman stated. This approach will enable healthcare organizations to define patient standards and ensure both organizations and patients can optimize the value of healthcare treatments.
- Healthcare Leaders Discuss Data Science for Clinical Research and Care Delivery
The final CRAACO leadership panel discussion examined opportunities for life science organizations to create value from data science and align incentives to help physicians conduct clinical research, improve data quality and preserve patient safety.
Discussion participants included:
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer
William Crown, PhD, Chief Science Officer, Optum Labs
Kenneth Mandl, MD, Director, Computational Health Informatics Program/Professor, Boston Children’s Hospital/Harvard Medical School
Kyu Rhee, MD, Chief Health Officer, IBM
Data and analytics together drive healthcare enablement. These technologies empower healthcare organizations with insights into patient behaviors and trends and can help these organizations uncover meaningful insights to drive CRAACO.
“There are many hooks into data and analytics, and there is also a decision support network developing from it,” Mandl said.
The role of technology in advancing key healthcare insights continues to expand, Rhee indicated.
Cloud, content and cognitive technologies help healthcare organizations gain insights from a large assortment of data. Yet collaborations may have the greatest impact on healthcare organizations because they allow these organizations to look beyond the healthcare setting and find innovative ways to engage all stakeholders, Rhee said.
Thank you to everyone who made the CRAACO event possible, especially Eli Lilly and Company and PMG Research, Inc.
April 3, 2017
Congratulations to Conference Forum Speakers Dr Robert Califf, Craig Lipset, and Marc Boutin on their Leadership Roles in the Newly Formed People-Centered Research Foundation
Source: Healthcare Informatics March 27, 2017 by David Raths Robert Califf, M.D., who stepped down as commissioner of the U.S. Food and Drug Administration in January, has been named chair of a new nonprofit organization, the People-Centered Research Foundation, which has been created to sustain and expand a national network for clinical research that originated […]
March 27, 2017
by David Raths
Robert Califf, M.D., who stepped down as commissioner of the U.S. Food and Drug Administration in January, has been named chair of a new nonprofit organization, the People-Centered Research Foundation, which has been created to sustain and expand a national network for clinical research that originated with funding from the Patient-Centered Outcomes Research Institute (PCORI) and studies conducted by the national Patient-Centered Clinical Research Network (PCORnet).
The PCORI web site said its board of governors has agreed to provide up to $25.4 million in additional infrastructure-building funds to support the long-term sustainability of PCORnet through PCRF, which was formed by PCORnet investigators to advance and support the network’s sustainability.
On its web site, PCRF said it would provide retrospective observational research using its data network, prospective research that collects new data from patients, and high-impact clinical trials. “Each study will deeply engage patients and clinicians in its design, conduct, and dissemination. A balanced mix of support from government, foundations, and industry will sponsor the studies. All projects will be aligned with the foundation’s mission of centering projects around the needs of people and their health.”
Califf also has returned to the Duke Clinical Research Institute, which he founded in 2006, as the Donald F. Fortin professor of cardiology. In a letter on the nonprofit’s web site, he said that PCRF would integrate people into all phases of research and the learning health system. “Patients, participants, patient advocates, and caregivers will constitute a meaningful percentage of our board; be involved in leadership roles in all committees; and participate in the development and execution of the research.”
He added that PCRF has a robust business plan in place, with seven members of what could grow to be a 13-member board, and plans to build a program management office that will be led by an executive director.
The other board members are:
- Richard Bankowitz, MD, MBA, FACP, Executive Vice President, Clinical Affairs, America’s Health Insurance Plans (AHIP)
- Josephine P. Briggs, MD, Director, National Center for Complementary and Integrative Health (NCCIH)
- Marc M. Boutin, JD, Chief Executive Officer, National Health Council (NHC)
- Donna Cryer, President & CEO of the Global Liver Institute
- Craig Lipset, MBA, Head of Clinical Innovation, Worldwide Research & Development, Pfizer Inc.
- Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson
Dr Robert Califf recently spoke at the R&D Leadership Summit and spoke at the Clinical Trial Collaborations conference. Marc Boutin also recently spoke at the R&D Leadership Summit and is a lead advisor and speaker at the Patients as Partners US conference. Craig Lipset is the co-chair of the DPharm: Disruptive Innovations to Advance Clinical Trials conference and spoke at the inaugural Clinical Research as a Care Option program.