Until recently, first line therapy for extensive stage small cell lung cancer has remained unchanged for over a decade. That translates to thousands of patients who volunteered for dozens of clinical trials that did not lead to a new treatment. Nearly half of those patients were randomized to receive standard-of-care therapy – ostensibly the same treatment they would have received if they had not enrolled on the trial. Open sharing of these clinical trial data sets through the Project Data Sphere® (PDS) platform has allowed us to see that standard-of-care treatment outcomes remained stable as well.

By receiving de-identified, patient-level data from several clinical trials using the same standard-of-care therapy, our analytics team (led by Professor Lorenzo Trippa, Dana-Farber Cancer Institute) combined the control arms from those trials into a larger, aggregated external data set. The method used to construct this External Control Arm will be published in 2020 and shared through the PDS platform.

Now that the External Control Arm has been developed, we will demonstrate applications of this tool in clinical trial interpretation and to benchmark real world data. In collaboration with our colleagues at the U.S. Food and Drug Administration, we will push the limits of the use of this type of data to understand how such external data can be productively used to improve clinical trials.

Gains made in this program can translate into smaller clinical trials with more patients receiving promising new therapies, accelerated trial timelines, and a potential reduction in the overall cost of bringing a new cancer therapy to market.

When the External Control Arm program launched at FDA-PDS Symposium VI in August 2018, there were big expectations but only a little data to support this research program.

Working from a list of studies developed from www.clinicaltrials.gov, stakeholders within the oncology clinical research community were contacted, resulting in data from three additional studies (to date) being provided to the Project Data Sphere platform. Data from these three studies, plus the data already available within the platform, provided the critical data mass to support true progress in the development of the first external control arm.

Armed with a Letter of Support from FDA encouraging organizations to provide SCLC datasets in support of this research program, Project Data Sphere has additionally projected that data from six more studies should become available for this research program in the near future.

Task Force Chair

Researchers

Progress