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Peer-Reviewed Articles

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.

Increased Data Transparency Unveils Terminology in Disarray

By René Allard, Frank Biedermann, Elke Ufer, Michael Schmitz, Kai Spielmann

Subject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.

Satisfaction of Healthy Subjects Participating in Phase I Clinical Trials

By John Sramek, Kurt Hauptmann, Hong Ding, Keith Fern, Neal R. Cutler, MD, Sherilyn Adcock, PhD

Assessing the satisfaction of healthy volunteers is important because of the vital role they play in the drug development process via assessment of safety of dose administration and pharmacokinetic characterization of the absorption, metabolism, and distribution of compounds in the body.

Forecast Enrollment Rate in Clinical Trials

By Gen Li

Instinctively, when there are more investigators/sites being deployed for a trial with a defined number of patients needed, we should expect shortened enrollment cycle time. This sounds right, but is it really?

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Blogs

ERT's Acquisition of PHT

By Lisa Henderson

ERT’s announcement of its intention to acquire PHT makes more than sense. And when speaking with the companies’ CEOs, Jim Corrigan and Philip Lee respectively, the potential for success is greater than any challenges the current clinical trials market could throw their way.

Changing the Context of European Pharma

By Peter O'Donnell

It seems only yesterday that the future for European pharma was personalized medicine. The European Union first gave the term official status in a formal paper in 2008, entitled a Renewed Vision for the Pharmaceutical Sector, in which the Commission included a section on ‘Towards more personalized medicines’.

An Alternative to Risk-Based Monitoring May Prove to be Beneficial

By Courtney McBean

That's because the discussion shifted away from one focused on changing monitoring methods and doing reduced source document verification (SDV) to 'intelligent monitoring.'

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Data Analysis

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.

Time for Another CRF Migration

Medidata took a look at how eCRF design complexity correlates with the number of migrations performed while a study is actively collecting subject data.

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