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

Real-World Evidence Forum

September 27 - 28, 2017
Philadelphia, PA

Blogs

ICH E6 R2 Roundtable Review

By Patrick Hughes

The release of the ICH E6 R2 guidance, which outlines a new approach to clinical trials operations, will have a major impact on the industry, writes Patrick Hughes.

J&J Propels Data Clinical Trial Data Sharing

By Moe Alsumidaie

In this interview, we speak to Dr. Joanne Waldstreicher, Chief Medical Officer of J&J’s Office of the Chief Medical Officer (OCMO), to discuss its data sharing program via the Yale University Open Data Access (YODA) Project.

Connecting Patients to Cutting-Edge Care

By Susan Weidner

How can manufacturers ensure their clinical trial methods are evolving along with their product portfolio? It starts by taking a patient-focused approach to trial design, writes Susan Weidner.

Noteworthy

The Case for Vendor Oversight for Small Sponsors

By Dawn Edgerton, Gerald L. Klein, Peter C. Johnson

Executives from Edgerton Data Consulting and MedSurgPI discuss biopharmaceutical and medical device companies outsourcing one or more aspects of their clinical trials.

The Value of Empowered CRAs in Rare Disease Studies

By Paul Bishop and Lyle Camblos

Executives from Atlantic Research Group discuss the importance of CRAs in rare disease clinical trials.

Afib Detection: True or False Due to Bad Quality Recordings

By Luc Dekie

This article discusses atrial fibrillation (Afib) detection and ECG recordings of the arrhythmia.

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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