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Leading the Way in Effective Drug Development

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Mar 02, 2023

Artificial Intelligence and Machine Learning Accelerate Rapidly in FDA Submissions

People working in clinical trials are sometimes criticized as late adopters of technology. However the reality is more complex. The Gartner 2019 CIO Agenda survey clearly outlined the biggest barriers to adoption of AI and machine learning (ML) as staff skills, understanding benefits and uses of AI/ML technologies, as well as data scope and quality.

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Feb 24, 2023

Adherence Is Much More Than One Data Point

Knowing a patient achieved an above average medication adherence rate can be a promising sign. It can also be a deceptive one.

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Nov 05, 2022

Parkinson’s Patient Advocate Sees Hope in Digital Biomarkers

Three years come to mind when patient advocate Cathy Molohan is discussing Parkinson's disease -- 1961, 2011, and 2020. The year 1961 is when Levodopa was first shown to have a "miraculous" effect in patients with Parkinson's disease (PD). Today, more than 6 decades later, Levodopa remains the most potent medication for PD.

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Oct 13, 2022

Breaking the Cycle: How Achieving Consistency in Global Privacy Legislation Will Bolster Patient Trust

Patient privacy and trust are two of the most critical aspects of any clinical trial’s success – patients must understand and feel confident in the protocols designed to protect their sensitive health information. Because patient privacy is such an incredibly important issue, governments across states and countries have differing ideas on how to best protect it.

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Sep 13, 2022

Understanding and Predicting Medication Adherence in Clinical Trials

Clinical trials often suffer from unplanned loss of statistical power due to low medication adherence. Non-adherence can range from failing to take a pill at a specified time to deliberately skipping the investigational therapy or even feigning pill ingestion (sometimes common in underlying conditions like Schizophrenia).

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Jul 26, 2022

Driving Data-driven Medicine to Advance Personalized Care

Clinical trials are often designed with the participant’s everyday life in mind – trying to gather as much clinically-relevant data in a controlled manner as possible while allowing individuals to live their regular lives. However, it is true that trials are artificial environments, and participants are actively monitored to ensure their safety and to determine the efficacy of a drug in development.