All posts by julie.schulman@duke.edu

PCORnet, PCORI’s Health Data Initiative, Commits to Advance White House Cancer Moonshot

WASHINGTON, DC (June 29, 2016) – The Patient-Centered Outcomes Research Institute (PCORI) today announced its support of Vice President Joe Biden’s Cancer Moonshot program to accelerate progress in cancer research and care through a series of commitments by PCORnet, PCORI’s ambitious effort to harness health data and patient partnerships to accelerate the pace and power of clinical research.

PCORnet, the National Patient-Centered Clinical Research Network, is a unique collaboration involving 33 individual partner networks working to help the nation conduct clinical research faster, more efficiently, and at lower cost by incorporating patient health information and other data. PCORnet launched with PCORI funding in 2013 and expanded in 2015.

“We and our PCORnet colleagues are delighted to work with the White House Cancer Moonshot Task Force, federal agencies, and private sector partners to support the Moonshot’s mission to advance the vital research needed to offer people with cancer and their families more effective care options,” said PCORI Executive Director Joe Selby, MD, MPH. “This exciting commitment by PCORnet is a natural extension of PCORI’s mission to fund research designed to show which care choices work best for whom under what circumstances, based on outcomes important to patients.”

To support the Cancer Moonshot, PCORnet commits to:

  1. Enhancing its highly representative national clinical research network—which includes data from more than 110 million patients and supports a learning healthcare system—to allow cancer and other large-scale research to be conducted with greater quality and efficiency.
  1. Creating data tables that include descriptive characteristics of patient cohorts treated for the most common types of cancer—including breast, colorectal, prostate, lung, and melanoma—within the 130 healthcare systems affiliated with PCORnet’s partner networks.
  1. Planning a Cancer Collaborative Research Group (CRG) within PCORnet that will convene patients, clinicians and investigators to: 1) identify and prioritize top research questions; 2) develop approaches for using real-world electronic data to address unmet research needs in cancer prevention, diagnosis, and treatment; and 3) reduce disparities in cancer care and outcomes.

PCORnet, through its partner networks, has already made substantial progress in supporting high-quality, patient-centered cancer research. Researchers involved with PCORnet’s partner networks have built observational data sets based on large cohorts of patients with colorectal, breast, hereditary ovarian and breast cancer, as well as pediatric cancers. The vast scale of PCORnet also supports research in rare cancers.

Among PCORnet partner networks with major investments in cancer research is the American BRCA Outcomes and Utilization of Testing Patient-Powered Research Network (ABOUT PPRN), a patient-driven network focused on hereditary breast and ovarian cancer. In addition, the Patient Outcomes Research to Advance Learning network (PORTAL) has developed a colorectal cancer cohort with detailed clinical data from more than 16,000 patients. The Greater Plains Collaborative network, which includes eight National Cancer Institute-designated cancer centers, has built a large breast cancer cohort. And PEDSnet, which encompasses eight pediatric health systems, provides resources on pediatric cancers.

The PCORnet Cancer CRG planning committee, presently led by patients, clinicians, and investigators from the PORTAL, GPC and the ABOUT networks, will survey the landscape of potential additional partners, both inside and outside of PCORnet, and create work plans for the research group. The Cancer CRG will build on PCORnet’s experience and resources of standardized EHR, clinical and patient-reported data. The planning group will seek funding from PCORI to establish the research group by October of 2016.

In addition to its support of patient-centered cancer research via PCORnet, PCORI has awarded nearly $157 million to support comparative clinical effectiveness (CER) studies related to cancer. These patient-centered studies, such as the WISDOM Trial and COMET Trial, compare two or more available options for cancer care with the goal of determining which works best for which patients given their needs and preferences. Among them are studies focusing on cancer survivors’ needs as well as on prevention, screening, and treatment.

Those interested in collaborating with PCORnet on the Cancer CRG may contact pmo@pcornet.org. To view PCORnet’s full commitment to the White House Cancer Moonshot Website, submitted on Friday, May 27, click here.

 

ABOUT PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research. More information is available at www.pcornet.org.

ABOUT PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

PCORnet Blog

Patient Involvement in Research: Innovative, Patient-Powered, Welcoming

Date: June 13, 2016

Author: Cherie C. Binns, RN BS MSCN, Research Committee Member for Multiple Sclerosis PPRN

Cherie Binns, received her nursing degree from Albany Medical Center, her degree in Gerontology from the University of Rhode Island, and is one of fewer than a thousand nurses worldwide to be certified in multiple sclerosis nursing. Cherie is a frequent presenter for patient education programs for multiple sclerosis and is a “Resource Finder” for many who find themselves “falling through the cracks.” Read more about Cherie Binns.


I’m a patient helping to change the culture of research and I am excited! It feels great to be empowered, encouraged, and a part of something larger than myself. I get to be a part of things I could only imagine someone else doing and do things I never really thought I could achieve. How did all this happen? I became part of a Patient-Powered Research Network (PPRN) that has a national and international membership. It is the brainchild of the Accelerated Cure Project for multiple sclerosis (MS) and is called, appropriately, iConquerMS™. I was asked if I would help out on a committee for a larger network, PCORnet, the National Patient-Centered Clinical Research Network, which is made up of 20 PPRNs and 13 CDRNs (Clinical Data Research Networks). This initiative of the Patient-Centered Outcomes Research Institute (PCORI) is designed to conduct health research faster, more efficiently, and at lower cost than ever before, and to do it with patients and other stakeholders as collaborators.

Whoa! I never saw myself in the research arena even as a test subject. I hated statistics classes in college. But then, between jobs, I was asked to lend my nursing expertise to coordinate a small clinical trial to try and find some sort of marker that showed that a drug was working in people with a chronic illness. That led to another project that put me in a conference center with more than a hundred other people who were committed to bringing a drug to market that would help people with gait problems walk more easily. I had been bitten by a bug of curiosity and excitement and felt intellectually stimulated and valuable for perhaps the first time in my life, or certainly for the first time in ages.

You see, for years I had been experiencing myriad symptoms that did not make sense: bone-crushing fatigue, visual disruptions, trouble walking, difficulty finding a word when trying to explain something (and more). It had sidelined my career as a home care case management nurse. Subsequently, these symptoms led to a diagnosis of MS, a disease that affects nearly half a million people in the United States and well over a million worldwide. Multiple sclerosis (MS) has no cure, but around the time of my diagnosis, a medication came on the market to help manage it. Today, there are twelve FDA-approved therapies available and more coming out in the next few years. Although I spent the better part of several years homebound, scooter dependent, and legally blind, proper management of my condition, change in lifestyle patterns, and education saw me improving considerably.

In the summer of 2014, I was approached by someone who had found me on LinkedIn when searching for people who might be a good fit for a research committee as part of a PPRN. This network was created to address research projects that had a direct impact on the MS population and would reach out to that particular group of people to ask what research was REALLY important to them and not just those in the research community. People wanted to know how to choose a therapy from the available choices. That information, to date, is not available but hopefully soon will be. “Why do women get MS at a rate almost three times that of men?” is another question being considered.

Today, there are PPRNs all over the country that are disease-specific, including some focused on rare diseases for which there are not yet any therapies. And hospitals, universities, clinics, and researchers are banding together to form CDRNs with combined resources to move the process more efficiently and with greater cost effectiveness. These CDRNs and PPRNs are working together within PCORnet, a “network of networks,” with energy, enthusiasm, cooperation, and resource-sharing to answer questions that will lead to greater access and uniformity in healthcare. They will lower costs and create faster, more efficient processes and protocols for doing research that gives us answers we need to live higher quality, healthier, and more productive lives.

You can be involved in patient-powered research as a person with a condition or a genetic likelihood of developing a specific illness, or as a caregiver, patient advocate, clinician, or researcher. All are welcome and encouraged to contribute thoughts, ideas, and skills to this amazing network that has come to include some of the most motivated, innovative, skilled, and empowered people in this country under the umbrella of PCORnet.

For more information go to www.PCORnet.org. To add your ideas and information to help find a cure for multiple sclerosis, go to www.iConquerMS.org.

Drawing on Mental Health “Experts-by-Experience”

Two leaders, Drs. Andrew Nierenberg and Roberta Tovey, of PCORnet’s Patient-Powered Research Network (PPRN), MoodNetwork, share their thoughts and excitement in a PCORI Guest Blog about the purpose, history, and impact of MoodNetwork, which is committed to changing how mood disorders are understood and treated in our society.

When it comes to depression and bipolar disorder, doctors and therapists have little evidence to predict which treatments will work for which people. And patients’ wealth of experience about their own disorders has often been overlooked. MoodNetwork, formed by researchers, patients, and other stakeholders, is a group of thousands of people with the disorders who can learn from each other and help clinicians figure out the best treatments for individuals.

PCORnet Leaders Participate in Policy Roundtable to Advance the Use of Real-World Evidence

Update 24 June 2016:  The Bipartisan Policy Center has issued the findings from the below Roundtable in a new report entitled Using Real World Evidence to Accelerate Safe and Effective Cures.


On May 25th 2016, PCORnet leaders Adrian Hernandez and Russell Rothman were invited to participate in a Bipartisan Policy Center roundtable focused on advancing the generation and use of real-world evidence.  The event was moderated by Andrew von Eschenbach, MD, former Commissioner of the Food and Drug Administration (FDA), and current President of the Samaritan Health Initiatives, Inc. The roundtable welcomed thought leaders from across industry and academia, including Amgen, Pfizer, Robert Wood Johnson Medical Group, and Duke, Columbia, and Yale Universities. Information generated from the roundtable and other activities, including interviews will multiple other members of PCORnet, will inform a final set of policy recommendations to be released by the Bipartisan Policy Center in late June. The roundtable is part of an effort led by the BPC on “FDA: Advancing Medical Innovation”, co-chaired by Former Senate Majority Leader Bill Frist (R-TN) and Former Congressman Bart Gordon (D-TN).

Goals of the effort include:

  • Improve the medical product development process
  • Increase regulatory clarity
  • Strengthen FDA’s ability to carry out its mission
  • Increase investment in medical products to address unmet and public health needs

To date, the policy center has issued a report and letter to guide the generation and use of real-world evidence, with additional recommendations planned.  PCORnet is excited to be involved in shaping these recommendations as we establish our ‘network of networks’ and leverage real-world data from the more than 110 million lives captured in PCORnet to support a learning U.S. healthcare system and enhance the quality and efficiency of large-scale clinical research.

Stay tuned for a public meeting on June 23 when the Bipartisan Policy Center will release findings from this roundtable.

Update 09 June 2016:  Register to attend the public follow-up meeting, entitled Using Real World Evidence to Accelerate Safe and Effective Cures, on June 23rd,  where Dr. Adrian Hernandez will be speaking.