ICH E6 Amendment Emphasizes Risk Based Approaches in Clinical Trials
In November 2016, ICH E6 was amended to reflect current industry needs and practices. The risk management processes included in the recent addendum focus on oversight activities and quality management of the clinical trial. There is no “out of the box” solution to implementing a risk based monitoring program and quality management system. In developing these programs, the sponsor should include applicable stakeholders, take into consideration associated risks for each phase of a clinical trial, and coordinate the responsibilities of managing identified risks.
Understanding the Final Revisions to the Common Rule and the Implications for Informed Consent
Originally promulgated in 1991, the Federal Policy for the Protection of Human Subjects (the Common Rule) codified the ethical framework for the conduct of research involving human participants that is conducted or supported by the federal government. Throughout the years technology and clinical research landscapes have modernized, making it essential for the Common Rule to reflect these advances. In the TRIbune Winter 2017 edition, we discussed proposed updates to the Common Rule as outlined in the Notice of Proposed Rulemaking (NPRM)”.
Selecting Study-Appropriate Clinical Sites in 3 Steps
In the industry we often hear staggering statistics about the number of trials that are delayed or fail to meet their goals. For example, you may have heard 45% of clinical trials are completed late, 70% of trials experience study start-up delays, and approximately 80% of trials fail to meet their initial target enrollment on time. Part of a major risk mitigation strategy to avoid some of these challenges is selecting clinical sites that fit the unique needs of the study – because when it comes to clinical research one size does not fit all.
What is New in the Chemical Safety Law?
Many of us working in the clinical trial and global public health arenas are familiar with the stringent United States (U.S.) and international drug safety laws and regulations ensure patient safety. But we might not often think about chemicals people are exposed to everyday that are not covered under those laws and regulations because they are not drugs, cosmetics, or food. In the past, these industrial chemicals, found in everything from fragrances to tires, have been regulated much less rigorously.
Going Global? Points to Consider When Planning International Trials
Trials conducted in non-U.S. countries, sometimes known in the Contract Research Organization (CRO) industry as Rest-of-World (ROW), must take into consideration several factors that may pose greater challenges than for trials limited to the U.S. This article offers practical advice based on TRI’s experience with global trials for managing country assessment and site selection, regulatory matters, safety reporting, clinical supplies, laboratory management, and most importantly, communication.
Proposed Updates to the Common Rule: Addressing a Changing Research Landscape and Its Effect on the Process of Informed Consent
The “Common Rule,” also known as the Federal Policy for the Protection of Human Subjects is the basic policy that governs all federally-supported research conducted today. Twenty-five years have passed since the Common Rule was codified, and since that time, much has changed, particularly when it comes to technological advancements that make areas like research genomics, bio-imaging, and informatics possible.
Saving Time in Clinical Operations through Data Visualization
Data visualization tools are used in a number of professional fields such as network engineering and finance to easily view how some data points relate to others. Did you know that these tools can also be used in clinical research? Data visualization tools can enable researchers to identify trends and observe interaction between specific factors within data sets. Data visualization tools provide insight that typical data management software cannot offer.