Peer-Reviewed Articles

Monoclonal Antibodies: Clinical Pharmacology Knowledge in Support of FIH and Early Development

By Narine Baririan, Pharm. D

There are several pharmacokinetic factors and peculiarities that should be considered carefully when designing and running first-in-human (FIH) studies for monoclonal antibodies.

Maximizing Immuno-Oncology Clinical Trial Success

By Luke S. Gill

Cancer immunotherapies require different standards for evaluating their safety and effectiveness. Understanding these standards—and the other major challenges of immuno-oncology studies—is critical to drug development success.

Master Protocols in Oncology: A Review of the Landscape

By Bradley Smith, PhD, Kathy Giusti, MBA, Richard Hamermesh, DBA, Dixie-Lee W. Esseltine, MD

With technology’s increasing ability to gather and analyze previously unmanageable data sets, and medicine’s forays into genomics and targeted therapies, the time of the master protocol may be at hand.

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.

CISCRP Corner

Patient Perspectives on Seeing Trial Results

The third in a series of results from the Center for Information and Study on Clinical Research Participation’s (CISCRP) landmark 2017 Perceptions & Insights Study.

Patient Input into Leveraging the Healthcare Professional’s Role

The second series of findings from CISCRP's 2017 Perceptions & Insights Study.

Public Clinical Research Literacy: New Insights

The first series of results from CISCRP's 2017 Perceptions & Insights Study.

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Events

BIO International Convention

June 04 - 07, 2018
Boston, MA

American Biomanufacturing Summit 2018

June 14 - August 15, 2018
Hyatt Regency San Francisco Airport, San Francisco, CA

7th Annual Publication and Clinical Trial Transparency

June 20 - 21, 2018
Amsterdam, The Netherlands

Blogs

Gene Therapy in Rare Diseases: Home and Dosing Site Considerations

By Mariah Baltezegar

With the rise in gene therapies entering clinical trials, it is important to address the operational challenges associated with these types of trials.

Clinical Trial mHealth Update: an EU Perspective

By Moe Alsumidaie

The biopharmaceutical industry continues to explore how mHealth can change clinical trials, as the discussion continued at Hanson Wade’s mHealth for Clinical Trials EU Summit in London.

What's the EMA Worth?

By Peter O'Donnell

On Europe Day, the agency itself is right now keener than ever to assess its worth and the value of its services to Europe and to Europeans.

Noteworthy

Risk Based Budgeting

By Artem Andrianov, PhD, Igor Stefanov

Adoption of the concept of Risk-Based Budgeting could help maintain the trial budget or even save the whole clinical trial.

Why Cash (and Checks) Aren’t King in Phase I Trials

By Dave Espenshade

The adoption of automated payment methods for phase I trials will allow for more effective clinical trials.

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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