Case Study

Turning RWD into RWE: External Control Arm for Label Expansion

Situation

A large global pharmaceutical company aimed to use real world data as an external control arm in their ongoing studies. They required access to a number of data sources as well as technological capabilities to generate data for their rapidly approaching regulatory filing deadline. Specifically, they sought to supplement studies with comparator cohorts in hematological malignancy. The required cohorts were highly segmented based on the inclusion criteria and data parameters defined

Challenge

Team was unable to access the required data for several months due to the common challenges of accessing global real world data: identifying relevant cohorts, understanding and managing regulatory requirements and having data available in one trusted research environment. Being able to access high quality patient data is key as real world data has to satisfy stringent data qualifications for use as External Control Arm (ECA). The patient data required for this research question was predominantly available across Europe as the drug was already on the market used as part of the standard of care. Handling data access in compliance with GDPR requires both an advanced privacy and technology solution.

Actions

Data Feasibility

BC Platforms leveraged its extended Global Data Partner network, with >16m high quality patient lives including longitudinal EMR data, to meet the data needs of this company.

Secure Patient Level Access

Within a few weeks BC Platforms was able to confirm the availability of data and proceeded with making the data available which included steps such as contracting data partners, ethics approval process and due to extensiveness of the data model, additional data processing steps such as harmonization and chart abstraction. Harmonized data from five data partners was brought into a single instance of BCP’s proprietary research environment for drug developer to conduct its analysis. The first release of data took place 8 weeks after receiving the research protocol.

Impact

Fast track access: This collaboration vastly accelerated research, surmounting typical data access challenges and enabling additional partnerships to continually meet data needs. The drug developer was able to access relevant data, generate insights and maintain the regulatory filing deadline. Ongoing collaboration: With this partnership, the pharma company has opened the door to collaborating with data partners, so researchers can keep adding to the final patient count in their selected cohorts.