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2021 SPAIG Award Honors Two Collaborations

1 October 2021 805 views No Comment
Michelle Shardell, University of Maryland School of Medicine; Willis Jensen, WL Gore and Associates;
John Kolassa, Rutgers University; and Rene Ellis, US Census Bureau

The annual Statistical Partnerships Among Academe, Industry, and Government (SPAIG) Award recognizes outstanding partnerships among academe, industry, and government organizations and aims to promote new cross-sector collaborations. This distinct ASA award emphasizes recognition of outstanding collaborations between organizations, while also recognizing key individual contributors.

Two SPAIG awards were announced as part of the 2021 Joint Statistical Meetings. The two winning collaborations both demonstrated impactful partnerships between two or more sectors. One SPAIG Award honors the collaboration between Dana-Farber Cancer Institute, Duke University, International Drug Development Institute, and multiple other institutions representing academe, government, and industry that contributed to the Intermediate Clinical Endpoints of Prostate Cancer (ICECaP) initiative.

Another SPAIG Award recognizes the joint collaboration between eight partners, spanning all three sectors, spearheaded by the Delphi research group at Carnegie Mellon University and including the US Centers for Disease Control and Prevention (CDC), Google, Facebook, Amazon, Change Healthcare, Optum, and Quidel Inc. These partners collaborated on the COVIDcast project.

We had the opportunity to learn more about the winning collaborations from individual contributors of each project. Susan Halabi—with input from Marc Buyse, Chris Sweeney, and Meredith Regan—responded to questions about the Intermediate Clinical Endpoints of Prostate Cancer (ICECaP) Initiative while Roni Rosenfeld and Ryan Tibshirani responded to questions about the COVIDcast Project.

Can you briefly describe how the collaboration started?

Prostate cancer is the second-leading cause of cancer death in men worldwide, many of whom present with curable high-risk localized prostate cancer. The main barrier to decreasing relapse and prostate cancer death has been the long time it takes to assess new therapies in randomized clinical trials using overall survival as the primary endpoint and the lack of validated surrogate endpoints of mortality. The initial project, conceived in 2012, focused on men with high-risk localized prostate cancer.

Chris Sweeney and Phillip Kantoff, medical oncologists from Dana-Farber Cancer Institute, submitted a proposal to the Prostate Cancer Foundation (PCF) and Howard Soule and Jonathan Simons from PCF prioritized its funding, which became the ICECaP initiative.

The result is a collaboration among 30 academic institutions, eight cooperative clinical trials groups, three corporations, and two government agencies, with investment from eight pharmaceutical companies (Astellas/Pfizer, Janssen, Takeda, Sotio, Sanofi, Bayer, and Dendreon) and two foundations [PCF (USA) and Prostate Cancer (UK)].

What are the major benefits coming from the collaboration that would not have otherwise happened?

The team exemplifies durable and robust collaboration that developed around globally relevant clinical issues. Specifically, this diverse team of statisticians and clinicians provided strong evidence for valid surrogate endpoints that would likely make a significant impact on future clinical trials in prostate cancer. The ICECaP collaboration has been significant in terms of depth and breadth and reflects transdisciplinary leadership, which includes statisticians and clinicians.

Among the results of this fruitful exchange are multiple ongoing projects aimed at identifying intermediate clinical endpoints of overall survival in men with high-risk and hormone-sensitive prostate cancer and developing prognostic models of clinical outcomes, harmonize endpoints, performing health economic analyses, and collecting tissues to understand biological aspects of prostate cancer.

Additionally, several articles have been published in high-tier medical journals, including statistical guidelines for reporting results of surrogate endpoint analysis published in the Journal of the National Cancer Institute (JNCI) Cancer Spectrum.

What have been the most rewarding and most challenging aspects of the collaboration?

One of the first papers emerging from this collaboration was the statistical analysis plan published in JNCI to support initiatives for pre-specification and transparency in research.

Another critical publication demonstrated that metastasis-free survival (MFS) is a strong surrogate of overall survival. This paper’s impact on decision-making has been noted by both the US Food and Drug Administration and European Medicines Agency, which now allows MFS as a primary endpoint in phase III clinical trials in men with high-risk prostate cancer.

Another rewarding aspect of this collaboration is the opportunities it provided for training, mentoring, and career development for master’s-level and postdoctoral statisticians and clinical fellows.

A key challenge was obtaining individual patient data from clinical trials. While researchers want to share data, resources are inadequate to support the efforts required to prepare data for sharing while meeting all regulatory patient privacy requirements.

What advice would you give to individuals and organizations looking to be more collaborative?

Statisticians are integral to advancing science and building partnerships with investigators from different disciplines. The partnership between statisticians and clinicians is synergistic and bridges gaps in scientific knowledge. Our experience has shown that this partnership has long-range impacts on clinical trials design and informs regulatory agencies. Moreover, statisticians contribute unique expertise and play a critical role in answering key and innovative questions. In summary, the whole collaborative team is much more effective than when individual scientists work in silos.

Can you briefly describe how the collaboration started?

Tibshirani: Some of these relationships were developed years before based on our group’s flu tracking and forecasting work (beginning in 2012). For many years, we’ve had a close relationship with the CDC through this work, which was solidified in 2019 when we became one of two national Centers of Excellence for Influenza Forecasting. We also had relationships with Quidel (medical device company and manufacturer of rapid flu and now COVID tests) and Optum (health information technology group operating under UnitedHealth Group).

Our relationships with Facebook and Google began in March 2020 through “cold” emails. We reached out to each separately to see if they would consider helping us run massive-scale, daily surveys asking people if they had COVID-related symptoms so we could compute real-time leading indicators of COVID-like illness. To our delight, they agreed, and the relationships grew.

The same was true of our relationship with Change Healthcare, except we asked them for help computing indicators of COVID activity based on deidentified medical insurance claims.

I would like to note that the collaboration with Google extended well beyond the initial surveys, which we ended in summer 2020 to focus on the surveys in partnership with Facebook. Most notably, they sent us 13 full-time people (engineers, PMs, and UX designers/researchers) to work with us pro-bono for six months through a Google.org fellowship.

What are the major benefits coming from the collaboration that would not have otherwise happened?

Tibshirani: There have been enormous benefits, so large it’s hard to describe succinctly. The survey we’re running with Facebook has received more than 20 million responses since April 2020 (around 50,000 per day). As far as we can tell, this is the largest US survey ever run outside of the census. This has been an extremely useful instrument well beyond COVID tracking and situational awareness because it sheds light on how the pandemic is affecting people in ways that have never been measured before. Without Facebook’s reach, this never would have been possible.

The Google.org fellowship was an amazing boost for us, and more valuable than any monetary gift they could have given. Not only did we accomplish more with them in that six-month period than we could have without them, but they also taught us so many important things. They made us “more professional” in the way we approach planning and executing work, which will continue to remain with us indefinitely.

Change Healthcare provided us with a wealth of electronic health record data that may be the most unique and most valuable of all. To give you a sense of scale, they process about half the US medical insurance claims! We are just at the tip of the iceberg here, and there are tons of important challenges remaining—not just for our COVID work, but for our group’s long-term goal of making epidemic tracking and forecasting (in general) as widely used and trusted as weather forecasting is today.

What have been the most rewarding and most challenging aspects of the collaboration?

Rosenfeld: The most rewarding aspect of the pandemic year collaborations, for me, was the feeling that everyone is aligned toward, and focused on, the same goal—fighting the pandemic. In many ways, it felt like war time. Now, wars are obviously bad (as are pandemics), but they unify the population in a way that is not possible in normal times. That is exactly what happened here: Obstacles were removed, creative solutions were found, and good will was lavished all around. Negotiations that would normally take years were concluded within days or weeks. This was very uplifting.

The most challenging aspects of the collaborations were that, because of the rapidly changing nature of the pandemic, the needs of our various users were continuously changing. So, on many occasions, we worked frantically with our partners to create a certain capability in record time only to find out it wasn’t fast enough and that by the time we deployed, our users’ needs had changed drastically.

One example of that is a system we developed to forecast the number of hospital beds needed in a given location on any day in the next 30 days by a cohort of COVID cases that were just diagnosed. This was critical to anticipating when hospital capacity would be exhausted and more drastic measures would need to be put into place (like opening emergency field hospitals, which take some time to set up). In the month or so it took us to develop and deliver our working solution, the surge in hospitalization abated and the focus of public health agencies moved to vaccine distribution and administration. My take-home lesson from this experience is that these partnerships and workstreams need to be maintained during “peacetime,” so we have working systems already in place when The Next One hits (as it no doubt will).

What advice would you give to individuals and organizations looking to be more collaborative?

Rosenfeld: I would relay something first heard from my wife (and later found out was attributed to Harry Truman): “It is amazing what you can accomplish if you do not care who gets the credit.” In war time, people tend to care more about getting things done than about getting credit for it. This unleashes amazing productivity.

Full List of ICECaP Collaborators (including medical doctors, with statistical roles highlighted, in alphabetical order)

Ove Andren, John Armstrong, Donald Berry, Michel Bolla, Marc Buyse (external statistical adviser), Simon Chowdhury, Noel Clarke, Joseph Chin; Laurence Collette, Matthew Cooperberg, Ian Davis, Jim Denham, James Denham, James Dignam, Savino Mauro Di Stasi, Mario Eisenberger, Karim Fizazi, Boris Freidlin, Silke Gillessen, Martin Gleave, Muriel Habibian, Susan Halabi (external statistical adviser), Anis Hamid, Nick James, Jonathan Jarow, Nancy Keating, Philip Kantoff, Gary Kelloff, Laurence Klotz, Andrew Kneebone, Himu Lukka, Malcolm Mason, Nicolas Mottet; Andrea Miyahira, Mari Nakabayashi, Wendy Parulekar, Meredith Regan (statistician), Howard Sandler, Oliver Sartor, Peter Scardino, Howard Scher, Richard Simon, Jonathan Simons, Eric Small, Howard Soule, Daniel Spratt, Srikala Sridhar, Allison Steigler, Martin Stockler, Christopher Sweeney (Overall PI), Matthew Sydes, Catherine Tangen, Ian Thompson, Bertrand Tombal, Anders Widmark, Thomas Wiegel, Manfred Wirth; Scott Williams, Eric Yeoh; Wanling Xie (statistician), Almudena Zapatero

Full List of COVIDcast Project Collaborators

Roni Rosenfeld, Ryan Tibshirani, and the Carnegie Mellon Delphi Group; Carrie Reed, Matt Biggerstaff, Michael Johansson, Rachel Slayton, Velma Lopez, Jo Walker and the CDC COVID-19 Modeling Team; Hal Varian, Brett Slatkin, the Google Surveys Team and Google.org’s CMU-Delphi Fellows; Kang-Xing Jin, Curtiss Cobb and the Demography and Survey Science, Data for Good and Health teams at Facebook; Swami Sivasubramanian, Alex Smola and Amazon AI at Amazon Web Services (AWS); Tim Suther, Craig Midgett, Andrew Harris, Mina Atia, Anil Konda and Jaydeep Kulkarni at Change Healthcare; John Santelli, Paul Nielsen, Danita Kiser and the Optum data team at Optum and John Tamerius, Jhobe Steadman and Torsten Auhorn at Quidel, Inc.

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