Peer-Reviewed Articles

Researchers Conduct NH Studies for Rare Diseases and Drug Development

By Thomas Ogorka

The use of Natural History studies in order to examine a rare disease that will help facilitate drug development programs.

Monitoring Temperature Control Throughout IMP Supply Journey

By Richard Segiel

How a single-source temperature management strategy can support a drug’s quality and integrity in transit—a process as important as the destination.

The Enrollment Rescue Dilemma: How Sponsors and Sites Can Make the Most of a Tough Situation

By Pete Fronte, Beth Harper

Survey uncovers key best practices that sponsors, CROs, and sites should consider when faced with patient enrollment challenges.

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

Rare Diseases & Orphan Products Breakthrough Summit

October 16 - 17, 2017
Washington Marriott Wardman Park, Washington, D.C.

Rare Diseases & Orphan Products Breakthrough Summit

October 16 - 17, 2017
Washington Marriott Wardman Park, Washington, D.C.

Speed to IND for Biologics

October 19 - 20, 2017
San Francisco, CA

Blogs

FDA Seeks Patient Input on Strategies to Increase Trial Enrollment & Improve Study Design

By Jill Wechsler

FDA advisory committee made up of patients comes together to improve clinical trials and product development through better study design and greater participation.

Clinical Trials Confusing—Even to Doctors

By Jill Wechsler

Most physicians and many specialists have limited understanding of clinical trial data and research findings presented in prescription drug promotional materials for professional audiences.

New mHealth Action Plan Released

By Moe Alsumidaie

The Duke Margolis Center for Health Policy (DMCHP) recently collaborated with the FDA to release an mHealth action plan entitled "Mobilizing mHealth Innovation for Real-World Evidence Generation."

Noteworthy

Latest Business and People News

By Applied Clinical Trials Editors

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

Vaccine-Induced Specific Immune Response Offers an Avenue to Potentiate Responses to Immune Checkpoint Inhibitor Therapy

By Nina Baluja, M.D.

Cancer vaccine-based immunotherapy may help overcome the resistance of certain tumors to immune checkpoint inhibitors, while immune checkpoint inhibitors may enhance the efficacy of cancer vaccine therapies.

Clinical Trials in Kazakhstan: Open For Business

By Vlad Bogin, MD, FACP, Andrey Tarakanov, MD

This brief overview of Kazakhstan presented by Vlad Bogin will help you get acquainted with this emerging clinical trial location.

eBooks

Clinical Trials for Rare Diseases

This eBook will focus on advancing research, drug development, and trial management in rare diseases. Articles cover considerations from virtual trials and eCOA to the case for highly-skilled CRAs.

View all eBooks

 

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