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Articles

Trials that address multiple questions simultaneously using a master protocol can be operationally complicated. These complexities can be managed, even in studies used to support a marketing application.

How to Address—and Overcome—Operational Challenges in Master Protocol Studies

87% of people surveyed said they had no concerns about a decentralized approach to clinical trials. 

Recent Data Shows Positive Attitudes for Decentralized Trials in Rare Disease Patients

A novel adaptive-block method of randomization to maximize the efficiency of overall treatment group balance, while maintaining balance at investigational centers in smaller sized studies, is proposed.

An Adaptive-Block Randomization Method when Stratifying by Investigator in Small-to Medium-Sized Studies

Recognizing pre-pandemic pain points, such as patient engagement and protocol development, could lead to post-pandemic trial success. 

Addressing the Needs of Clinical Trial Sites in a Post-COVID-19 World

Sponsors are beginning to make their study protocols public as pressure for a COVID-19 vaccine rises.

COVID Advances Clinical Trial Transparency

While not all clinical trial assessments can be done virtually, there are many that can be adapted for virtual use. 

What Clinical Trial Assessments Can Be Done Virtually?

This article highlights how C2N Diagnostics and Firma Clinical Research teamed up to create a successful Alzheimer's diagnostic clinical trial while allowing participants to remain in their homes.

Key Points to Success in Decentralized Alzheimer’s Diagnostic Clinical Trial

Vice President of Global Technology and Product Management, Chris Dailey, and Enterprise Architect at Cenduit LLC, Chris Driver, encourage all sponsors and CROs to take a strategic view of how to make an eClinical ecosystem function at its highest level.

Re-Imagining Integration for Quality Clinical Trials

Forming strategic alliances and collaborating to optimize study design can significantly improve pediatric drug development.

A United Front for Better Pediatric Clinical Trials

With technology’s increasing ability to gather and analyze previously unmanageable data sets, and medicine’s forays into genomics and targeted therapies, the time of the master protocol may be at hand.

Protocol Design