Peer-Reviewed Articles

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.

How Social Media is Transforming Pharma and Healthcare

By Nimita Limaye, PhD, Awani Saraogi

Outlining the growing attention and pursuits around social media in adverse event reporting and advancing patient-centric initiatives in clinical trials.   

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

Understanding the Investigator Usage of Individual Pharmaceutical Companies; the Pfizer Case

With Open Payments it is possible for Pfizer to better understand its own investigator usage pattern and how that pattern may differ from the practices of other pharmaceutical companies.

Investigator Detail in Open Payments

With Open Payments US investigator names and experience will become public knowledge.

The US and the Location of Clinical Sites

More recent ClinicalTrials.gov data indicate that the United States remains the central location for clinical trial activity.

ACT TV

Events

FDA Advisory Committee Master Class

April 26 - 27, 2018
Washington, DC

4th Annual Endpoint Adjudication

May 01 - 02, 2018
Philadelphia, PA

Clinical Trial Budgeting and Forecasting

May 02 - 03, 2018
Philadelphia, PA

Blogs

Agile in Life Sciences R&D

By Christina Corera, Jeffrey S. Handen, Ph.D

Agile Product Development Methodology holds great promise for use in Adaptive Clinical Study Development.

Bridging Clinical Research and Clinical Healthcare “Who Owns A Patient’s Data?”

By Lisa Henderson

Lisa Henderson talks about the topic of "who owns a patient's data" as discussed at the Bridging Clinical and Healthcare Conference 2018.

How Does GDPR Affect Clinical Trials?

By Greg Gogates

The EU General Data Protection Regulation is the most important change in data privacy regulation in 20 years.

Noteworthy

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.

Selecting Study-Appropriate Clinical Sites in 3 Steps

By Anais Silva

These three steps should take place in order to ensure an optimal site selection.

Special Populations Underrepresented in Oncology Research: Challenges and Solutions to Engage the Hispanic Population

By Carlos M. Naranjo, MD

Despite the evidence that the Hispanic population is increasing at a formidable rate, they not only face disadvantages in health care access, but are significantly underrepresented as participants in biomedical research.

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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