For Data Providers: Share Data
In just the past five years, there has been dramatic progress in sharing clinical trial data beyond an organization’s virtual walls. Project Data Sphere® has a unique place in the data-sharing ecosystem based on our specific focus on cancer, our strong ties to executives across the biopharmaceutical industry, FDA and NCI, and our primary focus on enabling research that impacts outcomes for cancer patients.
Today, the Project Data Sphere® platform provides researchers with data representing more than 120,000 patients and spanning more than twenty tumor types. This data has already led to at least 86 published peer-reviewed manuscripts, with more in development. But more data is needed – traditional clinical trial data that spans more tumor types and treatments and increases the depth of our data reserves, as well as imaging and genomic data that will increase the breadth of how we can support researchers.
New hypotheses are being tested every day based upon the data currently available within the platform, and new insights to improve cancer patient outcomes are on the horizon. Additional data can lead to improved outcomes for cancer patients around the world.
Project Data Sphere encourages all organizations that share data sets as part of this vital initiative to communicate this news to their internal and external communities through social media and more traditional communication channels. Through this outreach, we strongly believe that the data sharing community (including those who still struggle with the idea of sharing clinical trial data) will continue to grow more confident regarding data sharing in general, and data sharing via the Project Data Sphere cancer research platform in particular.
Many organizations have developed their own policies regarding data de-identification and/or anonymization. For those organizations seeking guidance, the following paper may prove to be a valuable resource: De-identification Guidance.
As the concept of data sharing matures across the clinical research community, organizational data sharing processes continue to evolve. To that end, the team at Project Data Sphere stands ready to work with your organization to streamline the delivery of data sets to the Project Data Sphere® cancer research platform. Critical steps along the way include:
- Legal review of the Project Data Sphere Data Sharing Agreement. Authorized users can download the template agreement here, or a copy of the agreement can be shared via email. The Project Data Share Data Sharing Agreement has been developed collaboratively with leading industry and academic research organizations, and all data available within the platform has been shared based upon the same Data Sharing Agreement.
- Identifying who within your organization is responsible for agreeing to share data to the Project Data Sphere cancer research platform.
- Applying to become a registered user of the Project Data Sphere cancer research platform
- Preparing data for sharing. This can include identifying the required supporting documents (protocol, case report form and data dictionary), determining which specific data (which data tables and/or which treatment arms) will be shared, and then de-identifying and/or anonymizing the data in accordance with your organization’s policies.
- Completing an online form that provides information about the data to be shared
- Completing and signing the Data Sharing Agreement
- Uploading data to the Project Data Sphere® platform