By Clinical Research Team  

March 27, 2025 | Digital Health Measurement Collaborative Community by the Digital Medicine Society released a suite of resources designed to effectively demonstrate the value of using digital endpoints in clinical trials; The Pistoia Alliance launched the next phase of its project to measure and reduce the carbon footprint of clinical trials; and more.

Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) released a suite of resources designed to help clinical trial sponsors and digital health technology (DHT) developers effectively demonstrate the value of using digital endpoints in clinical trials. DATAcc’s new resources are intended to guide stakeholders in leveraging data to make the business case for greater adoption of digital endpoints in clinical trials. The new resources include: the Digital Endpoints Value Framework, the Digital Endpoints ROI Calculator, the Digital Endpoints Business Case Template, and the Case Study Catalog. Press release.

Splash Clinical and C2N Diagnostics announced a partnership to improve recruitment efficiency for Alzheimer's disease clinical trials throughout the United States and globally. Under the partnership, Splash Clinical will provide a new clinical trial recruitment program that combines Splash's proprietary recruitment infrastructure with C2N's PrecivityAD2 blood tests. The partnership also includes a specialized patient concierge service that guides participants through the pre-screening process and coordinates PrecivityAD2 testing and trial participation, ensuring a smooth experience for both patients and sites while reducing time and resource demands. Press release.

The Pistoia Alliance launched the next phase of its project to measure and reduce the carbon footprint of clinical trials. The initiative will assess the environmental impact of digital trial delivery methods (e.g. eConsent and decentralized clinical trials) and digital health solutions (e.g. devices and apps), compared to traditional, paper-based approaches. By closing a critical gap in the understanding of whether digital technologies are more sustainable, the project will establish a standardized methodology for evaluating the use of digital tools in clinical trials. The Pistoia Alliance was recently named a winner of the Innovative Practices Award at Bio-IT World 2025 for their FAIR Maturity Matrix. Press release. 

Evinova announced an agreement with Quantum Leap Healthcare Collaborative to incorporate Evinova’s remote patient monitoring (RPM) solution into I-SPY 2.2. I-SPY 2.2 is the largest and longest-running 'platform' trial that provides a framework to study multiple novel therapeutic treatment arms for women with newly diagnosed, locally advanced breast cancer. Evinova’s RPM module will be used to alert healthcare professionals to early symptoms of interstitial lung disease, a potential adverse event for one treatment arm in the study. Press release.

Flatiron Health announced a collaboration with NRG Oncology (NRG) to deploy Flatiron Clinical Pipe in a multicenter NRG clinical trial. Flatiron Clinical Pipe is an electronic health record (EHR) to electronic data capture (EDC) connector that improves efficiency and reduces time and effort of clinical study data entry. This collaboration broadens Flatiron Clinical Pipe use cases to include NCTN-sponsored studies, applying Flatiron’s EHR-to-EDC technology to reduce the burden on NRG clinical trial site teams, streamline data management, and accelerate study timelines. Additionally, NRG and Flatiron will conduct a correlative study to assess the efficiency of Flatiron Clinical Pipe use compared to traditional data entry methods. Press release.

neuropacs Corp announced the results of a prospective multicenter study that evaluated neuropacs AI technology for diagnosing Parkinson’s disease and atypical parkinsonism. The study was published in JAMA Neurology (DOI: 10.1001/jamaneurol.2025.0112) and funded by grant U01NS119562 from the National Institutes of Health (National Institute of Neurological Disorders and Stroke). Press release.

The Center for Open Science (COS) has announced the launch of an innovative challenge aimed at advancing automated methods for evaluating research credibility. Supported by the Robert Wood Johnson Foundation, the Predicting Replicability Challenge seeks to accelerate the development of methods that could dramatically reduce the time and resources needed to assess research credibility. The challenge invites teams to develop algorithmic approaches that predict the likelihood of research claims being successfully replicated and encourages innovation and interdisciplinary collaboration, including partnerships between AI/ML experts and domain specialists in social-behavioral sciences. Press release.

Researchers at Washington University (WashU) in St. Louis has developed a foundation AI model that uses clinical notes from surgical patients to predict complications like pneumonia, blood clots, and infections. The new model could help reduce the rate of postoperative complications that affect roughly 10% of patients, which can lead to longer intensive care unit stays, higher mortality rates, and higher costs. An important capability of the model is its ability to identify risks of multiple complications. As complications often share underlying risk factors, a unified model can leverage these correlations to make more accurate predictions across various surgical outcomes. Press release.

Beckman Coulter Life Sciences, in partnership with Rarity Bioscience AB, offers a new approach to oncology research by extending the capabilities of flow cytometry to clinical molecular research. Under a co-exclusive distribution agreement, Beckman Coulter Life Sciences will market and distribute the Rarity Bioscience AB superRCA technology assays. This expands the global reach of this pioneering new solution which accelerates the detection of mutations by using flow cytometry with logarithmically higher sensitivity compared to current gold standard digital PCR (dPCR) method. Press release. 

Researchers at the University of Texas at Arlington are enrolling volunteers for the Arlington Study of Healthy Aging (ASHA), which will use advanced imaging, genetics, exercise science, neuroscience, and remote monitoring to investigate age-related health decline. The goal is to help individuals and health care practitioners better prevent the impact of disease on older adults. The team aims to enroll 600 volunteers between the ages of 50 and 80 to participate in the program. The study also emphasizes community engagement and will take four years to enroll and evaluate all volunteers. Press release.

TransCelerate BioPharma announced the release of 13 tools designed to assist pharma R&D sponsors and their ecosystem partners in adapting to the newly issued ICH E6(R3) Good Clinical Practice (GCP) guidelines. The array of tools covers six focus areas: risk proportionality, monitoring, trial design, risk management, investigators, and data governance. As a critical part of this initiative, TransCelerate partnered with the Association of Clinical Research Organizations (ACRO) to co-develop the tools related to risk management and data governance. This collaboration highlights the importance of leveraging shared expertise in addressing key challenges and optimizing clinical trial operations. Press release.