Peer-Reviewed Articles

How Do iComply? Regulatory Topics Surrounding mHealth in Clinical Trials

By Philip Coran

Outlining several critical areas of regulatory oversight that clinical trial researchers need to consider when using mHealth technologies.

The Growing Availability of Wearable Devices: A Perspective on Current Applications in Clinical Trials

By Niklas Morton, David Blackman

Pilot study evaluates the feasibility of using wearable devices in clinical data collection, including the training requirements for appropriate use of the mHealth technologies and the impact of the model on data quality and patient engagement.

Engagement Shift: Informed Consent in the Digital Era

By Jeffrey Litwin, MD

The argument for electronic informed consent as a vital cog in supporting today’s patient-centric push in clinical trials.

Data Analysis

Phase II-III Market Dynamics

Report shines light on the current state of the Phase II/III clinical trial market and its anticipated direction into 2020.

A Different Look at Protocol Procedure Complexity

A substantial increase in procedure complexity should be reflected in increasing per patient costs of Phase III clinical trials,which is not true from these data.

Competitive Pressure for First-in-Class Drugs is Intensifying

Study shows sharp reduction in market exclusivity periods for first-in-class treatment entrants.

Events

 

Publication & Clinical Trial Disclosure
June 22, 2016 - June 23, 2016 / Barcelona, Spain

DIA 2016 52nd Annual Meeting
June 26, 2016 - June 30, 2016 / Philadelphia, PA

Pharmacovigilance Final Rule Summit on IND Safety Reporting
August 16, 2016 - August 17, 2016 / Alexandria, VA

Central Labs and Sample Logistics Conference
August 24, 2016 - August 25, 2016 / Philadelphia, PA

World Drug Safety Congress Europe
September 14, 2016 - September 15, 2016 / Nice, France

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Blogs

Q&A: Research Data Promise vs. Reality

By Michael Christel

Today’s convergence of health data and technology is fun to watch unfold, but a focused vision on system and process integration—and the framework for continuous enrichment—will be key to future lasting gains for clinical research.

Preparing for the ICH E6 (R2) Addendum: A 3-Part Series

By Nick Neri

This 3-part series provides insight into ensuring compliance with the ICH E6 (R2) Addendum to take effect later this year. Part 3 covers the value of embracing a centralized, technology driven approach to risk based monitoring.

Cluster Randomized Trials – a HeadPost Study [SPONSORED]

By George Clinical

A study underway comparing the effects of head position post-stroke provides a potential model for obtaining informed consent in cluster randomized trials, where groupings of large numbers of patients often make the task very difficult.

Noteworthy

Future Directions of Cancer Immunotherapy in Clinical Trials

By Joseph Pierro, MD, Donald Cooper

Progress and innovation within oncology has accelerated to a paradigm that includes immunotherapy and bio-genomics. Collaborative approaches in the future will continue to transform treatments in hopes of improving patient quality of life.

Latest Business and People News

By Applied Clinical Trials Editors

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

EMA’s New Tool: PRIME

By Emma Beausang, PhD

In response to the debate over allowing patients timely access to new therapies and ensuring safety, the EMA launched the PRIority MEdicines (PRIME) scheme in March. The aim of this initiative is to build upon existing regulations in Europe to support product development in cases of unmet medical need.

E-Books

Oncology Clinical Trials

Oncology remains the therapeutic area with the most drug failures, the lowest numbers of patients enrolled and the highest with the number of drugs in clinical trials. Many trends in oncology clinical trials seek to address these challenges and include the use of biomarkers, immunotherapies, and adaptive designs.

 

Cardiac Safety Assessment Update

This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT--a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments—offers expert view on this regulatory change.

 

Clinical Trial Management

Clinical trials have increased in number and complexity for numerous reasons—global trials, outsourcing, protocol requirements, and multiple regulatory issues. Factor this with the increased need to bring efficiencies and lower prices to the clinical trial process, and the need to stay on top of trials only becomes more crucial. This eBook will include articles on logistics of clinical trials supplies, negotiating with investigative sites, use of e-signatures and more.

 

 

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