Building clinical trial data return from the inside out

New feature provides participant-level clinical trial data directly from Teckro’s digital platform into the patient’s hands

Teckro's existing clinical trials platform, provides role-based access to the crucial stakeholders in a clinical trial—sponsors, CROs, sites and patients. The addition of Patient Data Return allows patient-participants to digitally access their trial data and share with their healthcare provider.

Nigel Hughes, co-founder of Teckro, explained the impetus behind the new feature: "Transparency in clinical trials is no longer optional—it's an expectation. Patients should have easy access to their data, and sponsors need better visibility into how participants engage with trials. Our new feature simplifies both, helping sites and sponsors provide a better patient experience while ensuring compliance with evolving regulations and best practices."

Professor Brendan Buckley, chief medical officer of Teckro, added in an interview with Clinical Insider, "Participants in a clinical trial should generally be facilitated, if they wish, to access their own data captured in the trial. This bears on our basic personal right to access important data about ourselves, as well as contributing to the completeness of medical records."

Through Teckro's secure platform, they can log in, view their study-related documents, and export their data to share with their healthcare professional of choice.

Buckley said, "From a pragmatic point of view, trial participants are more likely to engage with more commitment if they feel true partnership in the study, and easy data access is a key part of this."

Patient engagement

Teckro was started 10 years ago to address the issues of the clinical trial process being fundamentally inefficient, based on the fact that most indicators of performance were largely offline. The platform was intentionally built as digital-first to support sponsors in how they improve digital engagement in their clinical trials, which is measurable and actionable.

The initial focus was on the digital protocol and making sure sites are engaged as that is a driver for better recruitment. The company has been expanding from this engagement for the last number of years.

In line with industry and participant needs, the platform evolved to take the same approach to patient engagement as site engagement. Participant data return sits within the Teckro for patient part of the app as is the first step toward offering participant functionality to sponsors to measure and track participant engagement, as noted, a key role in recruitment and retention.

Compliant foundation

While communicating trial results to participants is encouraged, the form that takes is widely variable.

For example, page 6 of the ICH E6 (R3) states: “The transparency of clinical trials includes timely registration on publicly accessible and recognised databases and the public posting of clinical trial results. Communicating trial results to participants should be considered. Such communication should be objective and non-promotional.” But clinical trial results on an individual level are not addressed in that document.

The organizations that represent the bulk of global pharmaceutical companies—EFPIA and PhRMA—released their guidelines in 2023 on how to responsibly share clinical trial data, including with patients who participate in clinical trials.

TransCelerate Biopharma also offers its “Return Participant Data” framework to further guide sponsors on how to provide this service.

And that’s another place where Teckro believes it can add value to the process based on their already regulatory and legally compliant platform. "Compliance is built into everything we do," Buckley explains. "Giving participants their data back has to be completely compliant with GDPR in Europe and HIPAA and so forth. And those local regulations in 78 countries around the world."

Beyond regulatory compliance, Teckro has focused on creating an intuitive, user-friendly interface that mirrors the simplicity of everyday apps. This approach helps toward widespread adoption and use of the feature. As Hughes points out, "If you have to train somebody on a system, you're creating a barrier straight away."

The early results of this initiative are promising. Teckro reports that multiple pilot participants have already logged in to access their information through the portal, enabling them to export and share their data.

For sponsors and sites, the integrated data return process offers real-time insights into patient engagement, improving trial efficiency and data integrity. This level of oversight allows for better management of the trial process and potentially leads to improved outcomes.

Hughes highlights the broader impact: "We just fundamentally believe it's the right thing to do. It's bringing that trusted partnership message even closer, and it makes an awful lot of sense for us."

Learn more about global clinical data disclosure at one of our upcoming events.

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