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).
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
Blogs
FDA Examines Eligibility Criteria in Clinical Trial Design and Product Development
Recent legislation authorizes further assessment of FDA eligibility policies and of NIH research standards.
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?”
Lisa Henderson talks about the topic of "who owns a patient's data" as discussed at the Bridging Clinical and Healthcare Conference 2018.
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
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.
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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