When your vision is to detect cancer in its earliest, most treatable stages, running large-scale clinical trials is paramount. For Freenome, a pioneering biotech developing next-generation blood tests for early cancer detection – this translates into hundreds of sites, thousands of participants, and endless data.
However, capturing data while managing patient-reported outcomes (PROs) and consent in large-scale trials can be risky. Additional risk arises with:
- Patient safety
- Data collection and management
- Data quality
- Coordination and collaboration with sites.
To achieve scale without compromising patient centricity or study performance, Freenome chose Medrio. With Medrio CDMS/EDC, eCOA/ePRO, and eConsent solutions, Freenome facilitates quality, compliant data collection for its three clinical trials, involving over 60,000 participants across more than 200 sites.
In this article, we explore five ways Medrio empowers Freenome to deliver data quality and compliance for large-scale trials through:
- Onboarding Multiple Sites at Pace
- Ensuring Site Adoption and Compliance
- Promoting Patient Centricity
- Driving Trial Efficiency
- Maintaining Control
Onboarding Multiple Sites at Pace
Freenome needed an user-friendly interface for managing their over 200 sites, which are organized differently and have various trial schedules. They also needed the ability to configure studies while adding new sites and deploying them rapidly for ongoing studies. Medrio makes configuration easy. As Yontao Lu, Ph.D., Freenome’s Director of Clinical Informatics & Data Science, explains, “When working with so many sites, it’s important to ensure setting up user roles, and access is quick and efficient. Site staff requires different privileges depending on roles, like entering data, raising queries, or generating reports to complete tasks.”
Yontao continues, “ Medrio EDC gives us a very flexible way to configure different roles and assign one or multiple roles to users – helping us to set up sites quickly and effectively ready for activation.”
Ensuring Site Adoption and Compliance
Setting up and configuring sites is one challenge, while ensuring site adoption and compliance is another. According to Yontao, successfully influencing site behavior comes down to two things:
- Training and support
- Clear guidelines and expectations
Yontao comments, “The training documents from Medrio, as well as clear guidelines and expectations for data entry and management, ensure a smooth transition for new users and promote data quality. Having a cost-effective solution and robust 24/7 customer support from Medrio means we can resolve unexpected issues as they arise.”
Implementing regular monitoring and auditing processes is another way Freenome influences site behavior to ensure data quality.
Yontao continues, “Close monitoring and auditing of sites helps us identify any issues or discrepancies in the data and allows for timely corrective actions to be taken.”
Promoting Patient Centricity
With ambitious enrollment targets, patient-centricity is key. ePRO and eConsent allow participants to complete patient-reported outcome (PRO) questionnaires and provide consent remotely from their own devices.
Freenome’s Senior Clinical Data Scientist, Aijing Gao, explains, “We implemented several solutions and strategies to ensure our trials were patient-centric, including introducing hybrid workflows using Medrio eConsent and ePRO.”
“Medrio eConsent sends automated emails or text notifications about new consent documents for participants to review and sign remotely. Site staff can launch consent documents for participants consenting on-site during face-to-face consultations. Medrio enables us to collect responses to the Medical History Questionnaire from participants remotely, which delivers enhanced convenience value for participants. Our engagement and retention rate is high because we’re providing a better experience to participants via Medrio technology,” continues Aijing.
Driving Trial Efficiency
Collaborating with Medrio during the protocol review process helped Freenome visualize key objectives. Aijing explains,“We wanted to remove site burden and promote quality data. Collaborating with Medrio early meant we identified barriers to efficiency and could implement processes to ease workloads by removing manual data transcription, for example.”
Medrio drives efficiency for Freenome by:
- Boosting participant understanding and engagement
- Improving data collection and management
- Lowing risk of data errors
- Reducing costs of data collection and monitoring
Medrio’s design is user-friendly with interactive multimedia content. This design helps participants complete consent processes and ePRO forms at their own pace while boosting understanding and engagement.
These benefits aren’t just good news for participants, as Aijing explains, “Utilizing these solutions and workflows delivers benefits to all stakeholders. Data collection and management are easier and more robust. The risk of data errors and missing data is much lower, as we’ve cut secondary data entry by removing the need for sites to transcribe paper PROs into the study database.”
Alijing continues, “Medrio solutions help minimize the risk of errors from multiple data points too. As far as cost savings are concerned, Medrio is reducing the cost of data collection and monitoring, which represents significant savings given the scale of the trials.”
More participants and sites mean more queries to manage. Luckily Medrio’s sophisticated functionality and suite of automated features empower Freenome to manage queries with speed, ease, and precision.
Yontao comments: “Medrio’s EDC automatically generates queries based on our predefined rules, which ensures nothing slips through the net. We take a continuous improvement approach to this, implementing new checks and auto queries learned as we progress. Data validation checks also help us to identify potential issues or discrepancies in the data in real time.”
“Once corrections are made and verified, the EDC system automatically closes queries, reducing site and monitor workload by eliminating manual query resolution. Source data verification is much quicker too, thanks to the EDC’s user-friendly design,” exclaims Yontao. With data collection happening remotely and in-clinic, monitoring study progress is vital to maintaining appropriate visibility and control.
Aijing explains, “We use several methods to monitor study progress, from data audit reports, form status reports, and approval events reports. Access to real-time visibility at our fingertips ensures we remain in complete control and prevent any small issues from becoming something bigger.”
Medrio’s API solutions provide additional benefits by enabling Freenome to generate customized reports to deliver enhanced oversight. Aijing comments, “Medrio’s Import API, Export API, and the EDC’s Data View API combine to provide us with in-depth, real-time understanding of performance, helping us champion enhanced data quality and compliance.”
Empowering Large-Scale Clinical Trials
Freenome’s mission to detect cancer in its earliest and most treatable stages through large-scale clinical trials is a monumental undertaking. With hundreds of sites, thousands of participants, and an immense volume of data, the challenges are substantial.
However, Freenome found a robust partner in Medrio, helping them deliver data quality and compliance for large-scale oncology trials.