Peer-Reviewed Articles
Monoclonal Antibodies: Clinical Pharmacology Knowledge in Support of FIH and Early Development
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).
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.
ACT TV
Events
American Biomanufacturing Summit 2018
June 14 - August 15, 2018
Hyatt Regency San Francisco Airport, San Francisco, CA
Blogs
New “Right-to-Try” Law Challenges FDA Oversight
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
Novartis Researches Novel Digital Biomarkers
John Reites, THREAD’s Chief Product Officer, will discuss eDROs and the FocalView App in this interview.
CRA Skills Lacking in Critical Areas
A global CRO’s data gathered using an objective monitoring simulation administered by CRA Assessments, LLC reveals that CRAs are consistently underperforming regardless of the level of experience or training.
Noteworthy
Setting up a Central Lab for a Clinical Trial
When less is more. Using three referral labs vs. one central lab.
EMA’s Demands for Plain-Language Summaries for Clinical Trial Results that can be Understood by Anyone Could Create new Challenges for Sponsors
By Pooja Phogat, Vidhi Vashisht
From 2019, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014, life sciences firms will be expected to prepare plain-language summaries for all Phase I through IV interventional trials, which can be understood by patients, the general public, and experts.
Clinical Trials Don't Have to Cost Too Much or Take Too Long
By Stephen Arlington, PhD, Paul Chew, MD, Annalisa Jenkins, MBBS, FRCP, Gen Li, PhD, MBA
A discussion of the cost and time put into 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.
Webcasts
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