Topic

Comprehensive Research Associates, Houston, TX, USA

Articles

Study Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.

Oversight Method Identifies Critical Errors Missed by Traditional Monitoring Approaches

Clinical trials must rely on internet surveys to incorporate the needs of industry and patients, but how can results be improved?

Anticipating Careless Responders in Survey Design and Analysis

Senior Vice President, Customer Success, CluePoints

Jonathan Rowe, PhD, MS, MA, has worked in the pharmaceutical industry across clinical, quality and corporate teams for over 25 years. He currently leads ZS’s clinical development quality, operations and risk management functions from the New York office.

How optimizing RBQM risk detection reduces the efforts caused by false signals.

The Eradication of False Signals in Monitoring

Survey among readers evaluates the trajectory of RWD and how it can be more widely adopted.

Current and Future Use  of Real-World Data 

Digital twins, defined as a typical demographic patient profile in a specific population, have the potential to help clinical trial design.

A Digital Twin on KRAS G12C NSCLC Patients with SCA Measured by PFS

Fully-integrated, component-based CDMS offers flexibility, customization, and efficiency.

Accelerating Clinical Trial Design and Operations 

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. 

Peer-Reviewed Articles