Abstract
The CEO Roundtable on Cancer's Project Data Sphere aims to accelerate cancer research by establishing a neutral platform for publicly sharing clinical trial data from industry and academia.
Industry-driven collaboration will round out access to comparative-arm data
“When patients enter clinical trials, they truly believe their information will be used to its best possibilities to advance cancer research,” says Charles Hugh-Jones, MD, vice president for medical affairs for North America at SanofiOncology in Bridgewater, NJ. “The reality is that it's not—it's often being used for a single trial for perhaps a single submission, and beyond that, it sits in a warehouse, collecting dust.”
Project Data Sphere, launched by the CEO Roundtable on Cancer's Life Sciences Consortium (LSC) and outlined by Hugh-Jones at an Institute of Medicine meeting in October, aims to accelerate cancer research by aggregating clinical trial data—overcoming the traditional barriers of intellectual property rights, patient rights and privacy concerns, cost concerns, and technology challenges.
Designed to establish a neutral platform for publicly sharing clinical trial data from industry and academia, Data Sphere was scheduled to start informally in November by publishing comparator-arm data from 2 Sanofiphase III trials, one for cabazitaxel as a treatment for metastatic prostate cancer and the other for iniparib for treatment of breast cancer. Both pharmaceutical companies and academic institutions are preparing other donations of trial data. Hugh-Jones hopes that 6 data sets will be available when the project officially kicks off in April 2013, and 30 by the end of 2013.
“Data sharing is an obvious and relatively straightforward way of giving us a head start in improving oncology outcomes,” says Hugh-Jones. “Project Data Sphere will allow all of us—academia, industry, and patients—to work together and learn how to aggregate clinical data sets, learn from past successes and mistakes, and prevent some of the duplication that goes on in research.”
“We're at a tipping point, where people are starting to realize that data sharing can be a precompetitive activity,” says Amy Abernethy, MD, associate professor of medicine at Duke University School of Medicine in Durham, NC. “Data Sphere is an important stepping stone in showing the value of sharing the data.”
Abernethy, one of the academic collaborators on Data Sphere, gives an example of a phase III cancer trial in which she was involved that was shut down surprisingly and perhaps prematurely because “we didn't know the natural history of the disease well enough; nobody knew how long patients survived. The pharmaceutical company just didn't have the data to design the trial well.”
Expanding the Collection
The first contributions to Data Sphere will be comparator-arm patient level data, but Hugh-Jones hopes to expand these resources. “Once people get comfortable with sharing comparative-arm data, I don't think it's a big step to get them thinking about sharing active-arm data as well,” he suggests.
“The biggest challenge for Project Data Sphere will be to encourage or educate people around why data sharing is acceptable and practical—provided that you adequately de-identify patient data in a secure environment, it's a perfectly reasonable thing to do,” Hugh-Jones says.
“Researchers get very proprietary about their data, but whose data really is it?” adds Abernethy. “The primary owners of the data are the patients themselves.”
“Patients want to maximize their contributions, so they will be interested in learning about data sharing,” comments Cindy Geoghegan, a long-term cancer survivor, patient advocate, and principal of the Patient and Partners consultancy in New York, NY. While patients are rightly concerned about protecting their privacy, “when you explain to them why and how they can help, you can get just about anything from them,” she says.
“Data Sphere has done a lot of work to ensure that de-identifying patients is done correctly,” adds Geoghegan, an advisor to the project. The project has developed a new patient data algorithm that is estimated to be 100 times safer than Safe Harbor record standards in protecting patient identity, while retaining critical aspects for cancer research analysis such as time-dependent endpoints.
“There is a fundamental inflection point going on,” declares Stephen Friend, MD, PhD, founder of Sage Bionetworks in Seattle, WA. “The research problems have become much bigger and the data more expensive, and industry now has passed academia in accepting a culture of sharing.”
“Both in academia and industry, cancer researchers are under so much pressure today,” sums up Hugh-Jones. “The environment is changing fundamentally, and we all have to look at new ways of working together.” —Eric Bender
Like Project Data Sphere, Transcelerate BioPharma is a recent initiative to accelerate clinical research through sharing of resources and precompetitive data.
Announced in September and based in Philadelphia, PA, the nonprofit initiative brings together Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Genentech, GlaxoSmithKline, Johnson & Johnson, Pfizer, and Sanofito collaboratively address industry-wide challenges in drug development.
The effort will focus first on 5 projects to improve clinical trial processes: a shared user interface for investigator site portals, mutual recognition of study-site qualification and training, a risk-based site monitoring approach, clinical data standards, and a drug-supply model.
“This collaborative approach in the precompetitive arena, utilizing the collective experience and resources of 10 leading drug companies and others to follow, has the promise to lead to new paradigms and cost savings in drug development,” comments Janet Woodcock, MD, director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research.
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