Peer-Reviewed Articles

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.

Acquiring Medical Guidance in Clinical Trials: Monitoring Team Perspective

By Mohamed El Malt, Vijayanand Rajendran

A critical part of clinical trial conduct is providing medical guidance by the responsible medical monitor to investigative sites and various operations team members, including, but not limited to, clinical research associates and clinical study managers.

Blogs

eSource: Not New But Not in Full Force?

By Lisa Henderson

eSource is not a new term. But eSource does seem to be getting a lot of attention lately.

Improving Orphan Drug Patient Recruitment

By Andrew Schafer

Despite the substantial difficulties associated with orphan drug trial recruitment, this segment of the drug development market is booming.

What You Need to Know About Apple ResearchKit

By Lisa Henderson

Last week, Apple unveiled ResearchKit, an open source software framework for medical and health research, to much interest among Apple watchers, health tech and clinical research experts.

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

Clinical Enterprise Architecture and Data Governance

March 25 - 26, 2015
Philadelphia, PA, USA

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