Peer-Reviewed Articles

eSource Records in Clinical Research: Keeping it Simple

By Jules T. Mitchel, Jonathan Helfgott, Tom Haag, Silvana Cappi, Imogene McCanless, Yong Joong Kim, Joonhyuk Choi, Timothy Cho, Dean A. Gittleman

There has been a recent thrust within the pharmaceutical industry to promote the transformation of the clinical trial process.

Determining Participation in Ukraine

By Nataliia Vietchinkina

Survey shows what keeps Ukrainians away from clinical trials.

Designing Quality Improvement Registries

By Michelle Leavy, Daniel M. Campion

Focusing on efficiency and sustainability from the start improves the likelihood of success.

The Current Status of Risk-Based Monitoring

By Linda B. Sullivan

A comprehensive survey by Metrics Champion Consortium

Blogs

Revised 'Cures' Proposal Seeks to Simplify Clinical Trials, Speed Approvals

By Jill Wechsler

Among the multiple proposals for stimulating drug development and revising regulatory processes, the 21st Century Cures initiative includes several provisions designed to streamline clinical research and the amount of data required to gain FDA approval of certain indications.

FDA Highlights Clinical Trial Demographics Through “Drug Snapshots” Listings

By Jill Wechsler

Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER).

Endpoints in Cancer Trials: Putting Patients First

By Brad Thompson PhD

In the debate over patient-centric considerations in cancer care, one main focus has been the choice of proper endpoints for clinical trials.

Data Analysis

Examining the Stats: The “One Time” Investigator

Do 50% of US investigators only conduct one clinical trial? Much of the misunderstanding behind this “one time” claim, which first surfaced in the 1990s, rests on a misunderstanding of the BMIS.

Adaptive Trial Designs Gaining Momentum

Faster go/no-go decisions is the primary driver of adaptive-design adoption by sponsors.

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.

Noteworthy

Having a Brain Wave? The Potential of Consumer Brain Monitoring Devices in Clinical Trials

By Bill Byrom, PhD

Aspects of brain health include the way we think, feel, play, work, recall information and sleep. Exercise, healthy eating and positive social interactions are already known to improve these aspects of brain health, as are continually exercising the cognitive abilities of our brains.

Business and People April 2015

By Miraj Barodia

New faces among the Pharma Industry rise the ranks.

eSource: RbM Evolution is Coupled with SDV Elimination

By Moe Alsumidaie

The emergence of risk-based monitoring (RbM) is creating a revolution in the way biopharmaceutical sponsors and CROs manage clinical trial quality.

eBooks


Real World Evidence in a Clinical Trials World

With a growing need for post-marketing safety databases, and increased need to collect qualitative information from patients in the pre- and post-market of a drug the evidence gathering from clinical trials onward is expanding. 


 

Risk-Based Monitoring in Clinical Trials

As acceptance for risk-based monitoring grows, this e-Book examines next steps for sponsors and CROs. This e-Book offers case studies, practical tips, and applications to enhance the effectiveness of a risk-based monitoring strategy.


 

Clinical Trials Data Sharing and Disclosure

This e-Book features information from a recent conference of global thought-leaders in clinical data disclosure and transparency, which address current practices, potential challenges and solutions for pharmaceutical companies complying with the regulatory, ethical and legal issues around clinical trial data sharing.

 

.

Events

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