Peer-Reviewed Articles

The Current Status of Risk-Based Monitoring

By Linda B. Sullivan

A comprehensive survey by Metrics Champion Consortium

De-identifying Clinical Trials Data

By Khaled El Emam, Kald Abdallah

Whether we are referring to CSRs or to IPD, the personal information of trial participants needs to be de-identified prior to release. This article will describe the available methods for de-identifying clinical trial data, and the relative strengths and weaknesses of each.

Evaluating the Effects of Therapy Masking

By Barbara A Ricker, Katherine M Seymour, Alexander R Arslan, April Slee, Ruth McBride, Jeffrey L Probstfield, MD

An important criterion for a well-conducted clinical trial is minimization of bias in endpoint assessment.

Technology’s Role in Clinical Trials

By Rick Morrison

How the use of eSource, eTMF, and other cloud-based solutions are changing clinical trials.

Blogs

Patient Perspective Plays Important Role in Development of New Diabetes Treatment

By Matthew Reaney

Trulicity® (dulaglutide), approved by the EMA in November 2014 for the treatment of Type 2 diabetes in adults, is the first diabetes drug to have a Patient Reported Outcome.

Hamburg Era Ends at FDA

By Jill Wechsler

FDA commissioner Margaret Hamburg has received praise and plaudits as she exits the Food and Drug Administration this week after six years on the job.

Patient Safety Considerations for Follow-On Non-Biologic Complex Drugs

By Scott Kolodny

Biologic drugs and non-biologic complex drugs have revolutionized the treatment of many difficult-to-treat diseases including cancer, multiple sclerosis, and chronic iron deficiency.

Data Analysis

Sponsor Preference of CRO Experience in Orphan Drug Trials

By 2020, orphan drug sales are expected to make up 19% of prescription drug sales, excluding generics.

PwC Data Analysis Highlights Our New Health Economy

PwC Health recently did some studies on the New Health Economy that encompasses our society today.

Five-Year Disease Prevalence Only One Driver of R&D Investment

The five-year figure doesn't always determine which cancer types are most commonly being studied in late-phase trials.

Noteworthy

eDiary System’s Importance in a Clinical Trial for Female Sexual Dysfunction

By Sheila Rocchio

Palatin Technologies is a biotech company focused on developing targeted, receptor-specific, peptide therapeutics for the treatment of diseases with significant, unmet medical needs and commercial potential.

Business and People March 2015

By Miraj Barodia, Applied Clinical Trials Editorial Staff

New faces among the Pharma Industry rise the ranks.

Case Study: Using RBM to Evaluate and Predict Site Engagement

By Moe Alsumidaie, Artem Andrianov, PhD

Clinical trial site engagement has been advocated as a critical component relating to a study’s performance and success, however, a minimum amount of data supports this connection.

Events

Partnerships in Clinical Trials

April 22 - 24, 2015
Boston Convention and Exhibition Center, Boston, MA, USA

eSource Data in Clinical Investigations Conference 2015

May 05, 2015
Wyndham Philadelphia Historic District, Philadelphia, PA, USA

2015 AAHRPP Conference

May 19, 2015
Hilton, Chicago, IL, USA