Trial Design Articles

Rare Diseases: Meeting the Unique Challenges of Orphan Drug Development

Jan 21, 2016

By Michael F. Murphy, M.D., Ph.D

This article explores the many challenges to creating a pharmaceutical development program for the treatment of a rare disease.

EMA Agrees to Autism Biomarkers

Jan 21, 2016

By Applied Clinical Trials Editors

The EU-AIMS Longitudinal European Autism Project (LEAP) is combining genetic testing, neuroimaging, cognitive testing and clinical assessments to identify biological risk markers associated with subtypes of autism.

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.

Trial Design News

Anti-Clotting Drug Faces Questions Due to Device Issues

An investigation published by the BMJ this week has raised new concerns about the validity of a trial that was used to gain approval for Xarelto from the U.S. and European regulators.

Cancer MoonShot 2020 Targets Drug Development Inefficiencies

Amgen, Celgene, Independence Blue Cross, Bank of America and many more collaborate to deliver immunotherapies more quickly to cancer patients through historic drug development alliance.

inVentiv Health Launches Phase I Services to the U.S.

New Phase I clinical in Miami offers gateway location to Latin America.

Bracket Releases Rater Station 4.0 eCOA Solution

The Rater Station℠ platform has been used extensively in Central Nervous System clinical trials, and version 4.0 is currently being used in two clinical trials that are actively recruiting.

CRF Health Selected for Oncology Trials

The sponsors will use CRF Health's TrialMax® platform to support data capture for quality of life issues during the post-progression phase.

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