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Jul22 The Protocol Quality Rating Tool (PQRT): A New Instrument for Evaluating Clinical Trial Protocols

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...

Intranasal insulin may have a use as a neuroprotective treatment for a multitude of diseases ranging from cardiac arrest to traumatic brain injury to Alzheimer’s disease. Animal data suggests that high doses of insulin may be required for neuroprotective effects. Current neuroprotective treatments ...

The use of cannabis has rapidly increased over the past decade. Understanding how the body processes cannabinoids like THC and CBD is critical for optimizing their safety and medical use. Both compounds undergo first-pass metabolism, primarily through cytochrome P450 (CYP) enzymes and UDP-glucurono...

Identification and stratification of patients with under-recognized metabolic disease is critical in addressing the Nonalcoholic Fatty Liver Disease (NAFLD)* public health crisis. Reliance on frontline healthcare recognition alone may contribute to delays in treatment, monitoring, and referrals for...

Early detection has been instrumental in reducing cancer mortality rates. With that, there has been a surge in the development of single-cancer detection (SCD) and multi-cancer detection (MCD) testing technology. In a rapidly evolving field, ensuring that all stakeholders are using consistent langu...

What is a digital twin? Imagine having a digital mechanistic model-based replica of a patient, enabling you to simulate various treatments and predict their outcomes – your “digital twin.” This powerful concept allows for personalized medicine by mirroring the patient's unique biology and ch...

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