As more clinical trials shift toward decentralized models, utilizing methods that enable remote monitoring and self-reported patient data are allowing for a patient-centric drug development process that does not require in-person clinical visits. Nevertheless, many challenges persist in ensuring not only that patients’ report their own data reliably, but that after doing so it is secured and protected for the benefit of both patients and trial outcomes. In particular, technology plays a key role in conducting and improving the vital communications at the core of clinical trials on a remote basis. Now, a first-of-its kind eClinical platform is leveraging blockchain to secure patient data to an immutable digital ledger, ensuring that accurate records are developed in real time and with secured authenticity. As technological innovation continues to transform the ways in which we capture and collect patient data, expanding the language coverage of clinical trial documents through medical translations is necessary to ensure that this data accurately reflects the growing linguistic and cultural diversity of patients participating in clinical trials.
As Clinical Trial Area reports, companies Crucial Data Solutions and Triall have collaborated to create the first ever end-to-end blockchain-based eClinical platform that establishes a completely trackable and immutable ledger of all data self-reported or collected during clinical trials. Specifically, this eClinical platform has been designed to enhance the reliability and transparency of data collected during decentralized clinical trials while also enabling interoperability with other clinical trial software systems that could be used to remotely collect and management data. Broadly, this blockchain-based platform encompasses all clinical trial functions, including documents that patients use to self-report outcomes and documents that sponsors and Contract Research Organizations (CROs) may use for regulatory compliance. Prior to their work on this project, Triall developed the first ever blockchain-based electronic Trial Master File (eTMF) application which uses blockchain timestamping to generate a verifiable collection of documents and data throughout the course of a clinical trial. While integrating innovative technology like blockchain into decentralized clinical trial models is emerging as an important solution to securing patient data, not addressing issues of data integrity and security has direct implications on patient recruitment and retention and even compliance with Good Clinical Principles (GCP) guidelines.
Patients taking part in clinical trials want assurance that their data is protected, and sponsors need accurate and consistent results in order to successfully bring products to new markets and address leading health challenges. While the balance of maintaining a decentralized model and upholding patient data protections and integrity is essential for reaching patients on a global scale, meaningful data cannot be collected without translations for clinical trial documents. For instance, TMFs are a repository of documents assembled over the course of trial and ensuring that patients who speak different languages can accurately report their data and interpret documents is crucial for ensuring the TMF complies with GCP guidelines and can be assessed by regulators. Moreover, translations in a time when clinical trials are becoming increasingly digitized mean that employing software localization is important for upholding the functionality and usability of documents across digital clinical trial applications and platforms. Patient recruitment and retention is also directly centered around patient rights and medical ethics and creating an environment where patients are understanding these rights is foundational to conducting a patient-centered clinical trial. To help meet the needs of ensuring accurate health can be collected globally, language service providers like CSOFT Health Sciences provide translations for documents essential to all phases of the clinical trial process. Learn more at lifesciences.csoftintl.com.