Translational Bytes

Sep23 Are We Missing the Risk? Rethinking Restraint-Based Cardiovascular Monitoring in Nonclinical Toxicology Studies

Identifying cardiovascular (CV) risks early in drug development is essential, especially for detecting arrhythmias and hemodynamic changes. Despite this, many nonclinical toxicology studies still rely on brief, restraint-based ECG and blood pressure measurements that often miss the timing of peak d...

Large language models (LLMs), like ChatGPT, are no longer just tech-world curiosities; they’re increasingly making their way into drug discovery and clinical development. In this new Clinical and Translational Science primer article , the authors walk through how LLM models work, what makes them...

Aug28 Pursuit of Standardized Data!

Liquid biopsies are tests for detecting a cancer-associated signal in a body fluid sample to improve outcomes for patients with cancer. BLOODPAC is a not for profit consortium that works to accelerate the development, validation and accessibility of liquid biopsies. More than 40 BLOODPAC members ha...

Data integrity remains a major challenge in decentralized clinical trials. Especially during eligibility assessment, ensuring comprehensive participant characterization is paramount in remote settings. To address this, our team conducted a randomized, open-label, single-center, fully remote trial i...

Chronic pain is a widespread issue that presents significant treatment challenges. There are a variety of pharmacotherapy options, with opioids among them. The two most widely prescribed opioids are hydrocodone and tramadol; however, their effectiveness is associated with CYP2D6 function, given the...

There is no accepted method to evaluate the quality of clinical trial protocol documents holistically. The Protocol Quality Rating Tool (PQRT) has been developed to assess comprehensiveness, organization, and consistency of clinical trial protocol documents. It has been tested on a library of sampl...

Digital Health Technologies (DHTs: comprising mobile applications, wearables, smart internet-connected devices) have the potential to inform patients’ functioning through remotely collected measurements and transform clinical trials with decentralized operations. Despite the strong potential, the e...

There remains a critical need to develop therapies for many diseases that currently lack treatments. This need is underscored by an appreciation that drug development, in general, has a high attrition rate, rising costs, and increased delay in bringing treatments to market. Investigator-sponsored c...

While machine learning (ML)-based predictions for in vitro ADME assays (absorption, distribution, metabolism, excretion) and noncompartmental analysis (NCA) based pharmacokinetics (PK) parameters are well established to prioritize compounds, the prediction of full plasma concentration time profil...

There is growing interest in using large language models (LLMs) to support clinical research. In particular, research on clinical trial registries has traditionally required considerable manual curation of data, which has hindered timely and up-to-date investigations on various topics. We hypothesi...

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