Trial Design Articles

Evolution of Value for Oncology Therapies

Sep 08, 2015

By Thomas F. Goss, Nicole Sweeney, Michael F Murphy, MD, PhD

In recent years, the United States has witnessed significant progress in the fight against cancer, with survival rates increasing from 49% in the mid-1970s to 68% today.

Designing Alzheimer’s Disease Clinical Trials For Success

Sep 08, 2015

By Jillian Scaife, Nick Simmons-Stern

Alzheimer’s disease is and will remain one of the most unyielding public health crises of the 21st century.

Quintiles' Phase I Unit Tackles Trial 'Shopping'

Aug 14, 2015

By Moe Alsumidaie

Clinical trial recruitment and enrollment has presented its challenges in many ways.

Human Challenge Studies in Early Phase Antiviral Development

Jul 08, 2015

By Adrian Wildfire, Bruno Speder

The concept of the human challenge model (HCM) originated from early societal attempts to halt the spread of acute diseases within their own communities

TransCelerate’s Placebo and SOC Data Sharing Initiative

May 05, 2015

By Moe Alsumidaie

TransCelerate recently launched the Placebo and Standard of Care Data Sharing Initiative in order to foster a data sharing infrastructure between TransCelerate member companies.

Trial Design News

Japan’s New Agency Selects Certara Solution

AMED is expected to employ Phoenix WinNonlin to create PK profiles, and assess bioavailability for new drug candidates in its preclinical program to discover which hold the most therapeutic potential and should be progressed into clinical trials.

CTI Analyzes TB Natural History Database

The analysis compared various manifestations between genotypes and to determine if correlations exist between TSC symptoms and the TSC gene mutation.

Certara, Paidion Research Form Pediatric Drug Partnership

Certara® and Paidion Research, announced a new partnership to address the challenges inherent in pediatric drug development.

Chinese Biopharma Adopts Medidata Cloud in Pediatric Vaccine Program

Medidata, a global provider of cloud-based solutions for clinical research in life sciences, announced that its Clinical Cloud platform has been adopted by Walvax Biotechnology.

Transparency Life Sciences’ Trial to Assess Decentralized Data Collection

The first patient has been enrolled in an innovative ulcerative colitis clinical trial designed to assess the feasibility of replacing most conventional patient site visits with data collected using a combination of decentralized methods, including digital measurements, telemonitoring, remote video visits with clinical trial staff and blood collections by visiting nurses.

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