Forte’s mission to better connect Sites and Sponsors is embodied in the Trial Data Exchange (formerly known as DIRECT). Our goal is to standardize and automate the data exchange between stakeholders rather than relying on per protocol solutions, manual data entry and manual report compilation. While the Trial Data Exchange will be able to exchange multiple categories of data, today I’m going to focus on Case Report Form (CRF) data generally captured as eSource in a site’s existing systems. By inverting the focus from per protocol solutions to holistic site-wide solutions that utilize industry standards, we can revolutionize the use of eSource in clinical trials.
Challenges with Today’s Solutions
There are a myriad of eSource projects, pilots and solutions in the industry today. Many of them focus on per protocol or per sponsor solutions which can cause challenges for sites.
Example 1 – Sponsors provide an eSource tool to sites
When a trial sponsor provides an eSource tool to be used on a specific study, it is really replacing the external electronic data capture (EDC) system with another data collection system for the site staff to manage. Many large research organizations have electronic health record (EHR) systems and Clinical Trial Management Systems (CTMS), where they are already tracking study data. By adding an eSource tool to the mix, sites are forced to adopt sponsor-specific or protocol-specific systems for collecting study data, in addition to their existing systems. There is often overlap between the eSource systems and their existing systems, continuing the cycle of duplicate data entry we see when sites must enter data into their EHR and sponsor-provided EDC systems.
Provisioning eSource systems for sites is a financial investment for the sponsor and also raises the question of eSource control. US and European regulations require that sites maintain control of their source data. If the eSource tool is provided by a sponsor, then data control, access and long-term availability must be addressed to ensure that sites truly do control their source.
Finally, when sites work with multiple sponsors on many trials, they are faced with multiple eSource tools in the same way they must work in multiple EDC systems today. Sites still face the challenge of multiple accounts in multiple systems in order to complete their work.
Example 2 – Sponsors request data directly from site EHR systems
To avoid the concerns noted above with protocol-specific eSource systems, many sponsors and industry groups have focused on direct access to EHR systems for study data. This is a positive move, in that it eliminates protocol-specific systems; however, there are concerns specific to this approach that must be acknowledged:
Not all source data is in the EHR
While there is a wealth of data in EHR systems, sites have other systems, such as imaging and LIMs systems. Some information, such as relatedness of AEs to the protocol study treatment, is not stored in any electronic system and must be collected via site source paper worksheets, added to an existing eSource system, or entered directly into the EDC system as direct data capture.
Sites need to limit sponsor access to only protocol-specified data
The EHR contains protected health information (PHI) and other non-protocol specific information, so sites need to ensure that sponsors are only able to retrieve protocol-required data while protecting confidential patient information. This security challenge has not yet been adequately addressed in an automated fashion. Many sites rely on manual extracts and reporting out of their EHR systems when providing eSource to sponsors. This manual process can result in delays in data delivery.
Sponsors face technical challenges and overhead in connecting to a variety of site systems
Different EHR systems, firewalls and security procedures at sites result in a lot of overhead and customization for sponsors to connect to source systems at different study sites.
A Site-Centric Approach is the Answer
Sites need to maintain control of and consolidate their eSource for sponsor access, while Sponsors need a consistent method for retrieving eSource from sites.
Forte is working with sites to integrate their various systems and provide a standard endpoint to sponsors for data access. Sites will pull protocol-specific data into a central area and provide secure access to sponsors. Sites will also be able to use this tool to capture protocol-specific elements, such as AE relatedness to study treatment.
Using this approach, sites benefit by utilizing their existing systems to reduce manual data entry and aggregate protocol-specific data for sponsor consumption, while sponsors no longer involve themselves in site eSource and instead rely on standard endpoints across protocols to gain access to protocol-specific data. Sites and Sponsors are truly better together!
Learn More at Onsemble
I’m very excited about Forte’s vision to better connect Sites and Sponsors as well as the progress that the EDC team is making. If you’d like to learn more, consider joining me at the Spring Onsemble Conference, where the Forte Leadership and Product teams will provide an update on our advancements in helping trial teams transform the clinical research industry.