Peer-Reviewed Articles

Layperson Summary in the EU: Analysis of the Debate and Personal Remarks

By M. Zaninelli, E. Ornago, E. Sala, PhD, A. Ferrari, MD, PhD

Outlining considerations on layperson summary writing of clinical trial results in Europe, and proposing a "reader-centered" approach to constructing these summaries.

The ‘Pre’ Clinical Conversation: Dialogue Strategies Uncovered

By Lauren Walter

Audio study analyzes the communicative exchange factors between doctors and patients before enrollment—to better inform recruitment tactics.

Engaging Patients & Clinicians: Lessons from the PALM Registry

By Vincent Miller

Case study evaluates the use of a mobile device tool for simplifying clinical trial patient enrollment and data collection.

Comply with ICH E6 (R2)

The ICH E6 (R2) GCP Guideline became final in November 2016. As noted in the Guideline, since the original ICH E6 (R1) was released, clinical trials were performed in a largely paper-based process. E6 (R2) was developed to address the increased scale, complexity, and cost of clinical trials, and to include the advances that have been made in electronic data recording and reporting technologies, as well as the implementation of other approaches and, in fact, encourages the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
 

The articles can help ensure your GCP is up to par in the areas included in the ICH E6 (R2).
 

Read more.

Data Analysis

Pinpointing Phase III Trials in Emerging Countries

Most clinical trial activity for Phase III trials takes place in the traditional North American and European markets.

How Important is Big Data?

Survey collects thoughts from industry professionals on the current and future impact of big data in clinical trials.

Measuring the Added Time of Complicated Phase III Studies

This analysis uses a large dataset to forecast the study completion time costs of specific protocol designs and execution plans.

ACT TV

Events

Transformative Trial Models & Engagement

August 22 - 23, 2017
Wyndham Historic District, Philadelphia, Pennslyvania

Global Risk-Based Monitoring

September 14 - 15, 2017
Occidental Atenea Mar, Barcelona, Spain

Interactive Response Technologies in Clinical Trials 2017

October 26 - 27, 2017
Philadelphia, Pennsylvania

Blogs

Calling More Clinical Trial Participants

By Jill Wechsler

Jill Wechsler discusses the importance of clinical trial participants and the challenges FDA faces in expanding patient engagement.

Brexit Challenges Still Failing to Convince the UK of Grim Realities

By Peter O'Donnell

Peter O'Donnell discusses Brexit challenges and how the life sciences industry is affected.

The Success of Cell Therapies Will Depend on Automation

By Rolf Ehrhardt

In this article, MedCision executive discusses cell therapies.

Noteworthy

Latest Business and People News

By Applied Clinical Trials Editors

Updated employee announcements, business news, awards and recognition in the industry today.

High Quality ECG Recording Assurance

By Luc Dekie

This article discusses the importance of good patient preparation, lead hook-up, and the quality checks that can be performed to ascertain that an ECG is of good quality.

Six Steps to Ensuring Successful Clinical Trial Imaging

By Amit Vasanji, PhD and Brett A. Hoover

Amit Vasanji, PhD and Brett A Hoover from ERT discuss technology and the steps to successful clinical trials.

E-Books

Preclinical and Early Stage Research
Translational medicine; bench-to-bedside; agile development. All these terms use updated processes, new technologies and data to inform decisions earlier in clinical development. Supported by expedited regulatory pathways, which require extensive safety monitoring to accompany these earlier approvals, has made the gaps between preclinical and clinical a looming reality.

 

Cancer’s R&D Convergence
Cancer's R&D Convergence will highlight the changing landscape for clinical trials in this therapeutic area based on the promise of the Cancer MoonShot initiative, along with new oncology immunotherapies.

 

 

Risk-Based Monitoring in Clinical Trials

Have the roles of the monitor advanced? How are CRAs accepting the change? How is pharma implementing RBM—is it more remote, centralized or a combination? How important is eSource to RBM? This eBook will highlight articles that answer these question.

 

 

 

View all e-books

 

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