“Secondary analysis of patient-level data is valuable,” said Bill Louv, President of PDS. “Analyzing the combined datasets increases statistical power to learn more about standard-of-care outcomes, rare adverse events, treatment effects in patient subsets, and reproducibility of results. That’s not possible with single datasets.”
Louv said less than 1 percent of data is reused in this manner despite the existence of multiple sites offering inventories, metadata, and controlled access to the majority of clinical trials sponsored by the pharmaceutical industry.
The mission of Project Data Sphere (www.projectdatasphere.org) is to improve outcomes for cancer patients by openly sharing data, convening world class experts, and collaborating across industry and regulators to catalyze new scientific insights that accelerate delivery of effective treatments to patients.
In the six years since it launched, the PDS platform has grown from nine datasets to more than 150 and has been accessed by more than 3,000 scientists making more than 26,000 downloads of information. The data covers more than 160,000 patient lives in clinical trials studying prostate, breast, colorectal, non-small cell lung, Merkel cell, and pancreatic cancers.
New data types are being added and they include real world data, images, and genomics information. There also is curated data, including some from RTI International that is enhanced with social, economic, and health care-related data from the national Medical Expenditure Panel Survey (MEPS). At least two publications have focused on this analytically enhanced data that enable researchers to assess the impact of socioeconomic factors on cancer survival and related outcomes.
The PDS platform is home to the world’s largest curated prostate cancer dataset, which yielded more than 25 publications in peer-reviewed journals. The Prostate Cancer DREAM Challenge, which generated the comprehensive dataset, attracted 50 international teams to help predict survival for prostate cancer patients and treatment discontinuation for those treated with docetaxel. The Challenge produced a model that accurately predicts patient outcomes that could lead to improved clinical trial design and treatment options.
Three years ago, the platform amassed enough data to build a portfolio of research programs. Those programs focus on innovative trial designs, automating lesion annotation, streamlining adverse event reporting and management of patients on immunotherapy, and multi-institutional registry-building and common data models.
The steering committee of each research program includes an observer from the FDA Oncology Center of Excellence. This activity is governed by a Public-Private Partnership between FDA and PDS. The senior sponsor of the PPP is Paul Kluetz, Associate Director of the FDA Oncology Center of Excellence.
FDA and PDS also have worked together to convene experts from academia, industry, and government to address the latest issues in oncology research. The tenth symposium in the series will be held Sept. 23 and the focus is on defining a pathway to greater reuse of trial data. Learn more here: https://www.projectdatasphere.org/events-symposia/symposium/symposium-x-data-sharing
About Project Data Sphere
PDS is an independent initiative of the CEO Roundtable on Cancer, is a 501(c)(3) nonprofit corporation founded by President George H.W. Bush in 2001 to develop and implement initiatives that reduce the risk of cancer, enable early diagnosis, facilitate access to the best available treatments, and hasten the discovery of novel and more effective anti-cancer therapies.
For more information, visit ProjectDataSphere.org.
SOURCE Project Data Sphere
