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Using venture philanthropy to get promising drug candidates past “the valley of death”-and supported by advanced scientific technology-rare disease patient organizations have moved beyond being just hopeful influencers, to now becoming powerful forces for change. 

Rare Patient Advocacy Groups Reach Tipping Point of Influence

A recent survey shows that 40% of pediatric trials conducted between 2008 and 2011 were never finished or published. One of the main challenges is the need to collect multiple sequential blood samples. Which, mircosampling, could be the answer to. 

DIY Blood Sampling for Pediatric Clinical Trials—The Patients Perspective

Chris Barker, an Independent Statistical Consultant, discusses the differences and biases in summaries obtained from a database called PDQ vs. CTG. 

Biases in Characterization of Oncology Trials for Policy Decisions

How to account and adjust for covariates in clinical trial randomization-and be confident about uncertainty. 

The Well-Adjusted Statistician: Analysis of Covariance Explained

Using data analytics to introduce parallel processes to optimize and accelerate clinical trials.

Analytics and Metrics Help Pinpoint Costs of Study Startup

Exploring that pivotal question for clinical investigators, sponsors, and global CROs.

To Sign or Not to Sign FDA Form 1572?

Certified principal investigator certification as a predictor of major and critical protocol deviations in clinical trials.

Does PI Certification Make a Difference?

There are several pharmacokinetic factors and peculiarities that should be considered carefully when designing and running first-in-human (FIH) studies for monoclonal antibodies.

Monoclonal Antibodies: Clinical Pharmacology Knowledge in Support of FIH and Early Development

Cancer immunotherapies require different standards for evaluating their safety and effectiveness. Understanding these standards-and the other major challenges of immuno-oncology studies-is critical to drug development success.


Maximizing Immuno-Oncology Clinical Trial Success

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.

Peer-Reviewed Articles