Clinical Guest Contributors
Age Diversity In Clinical Trials: Why It Matters
Clinical trials are essential for evaluating the safety and efficacy of new treatments before they are approved for use by patients. However, a new report from the International Longevity Centre (ILC), in collaboration with RBW Consulting, highlights a significant problem in the clinical trial process: the underrepresentation of older adults.
Considerations For Compliance With CTIS Submissions Under The EU-CTR
This article outlines the process for sponsors in transitioning from an EU-CTD to an EU-CTR CTIS submission process. It provides guidance on redacting both personal data and confidential commercial information (CCI) appropriately, with detailed advice on how to identify and assess CCI for redaction, as well as strategies for minimizing the risk.
How Predictive Can Regulatory Drug Abuse Potential Investigations Be in Animals?
Is addiction attributed to “the animal or the human within us” or is substance abuse unique to humans? This question has intrigued me since the EMA guidance on Non-clinical Investigation of the Dependence Potential of Medicinal Products in 2006 and the FDA guidance on Assessment of Abuse Potential of Drugs in 2010 have requested the performance of dedicated studies in animals. Let's take a closer look at the matter.
Leveraging Genetics To Inform Clinical Trials And Drug Development In Alzheimer’s Disease
At the Eisai Center for Genetics Guided Dementia Discovery (G2D2), the discovery process starts with human genetics as it aims to better understand the genesis of dementia, including Alzheimer’s disease (AD). Because genetics lend greater insight into what causes disease versus how the body changes in response to a disease, Eisai has more confidence in selecting targets for therapeutic modulation based on genetic evidence.
What If We Could Do Clinical Trials Before We Do Clinical Trials?
New techniques are not only proving to be more effective than animal testing but will herald a completely new way of investigating novel treatments. Using these techniques, like human chip models, medical researchers will be able to actually run “clinical trials” before testing a drug in live humans.
De-Risking Cell And Gene Therapy Clinical Trials
Ohio State University Gene Therapy Institute's Dr. Russell Lonser explains five major reasons for the early failures in direct delivery gene therapy trials, methods and technologies to increase the efficacy of direct drug delivery, and more.
Becoming A PI: The Power of Physician-To-Physician Recruitment
Principal investigators (PI) can be in short supply. So, what's the best way to encourage more physicians to become PIs? By enlisting the help of other physicians. Here, Dr. Katie Smentek shares her experience of becoming her clinic's first PI and how she encourages fellow doctors to become investigators in clinical trials.
Clinical Trial Diversity, Flexibility Championed By The Food And Drug Omnibus Reform Act
The Food and Drug Omnibus Reform Act, signed into law by President Biden on Dec. 29, 2022, includes provisions intended to modernize clinical trials and are broadly divided into two categories: encouraging the enrollment of diverse populations and facilitating novel clinical trial designs.
Remote Candidate Fraud In Clinical Research: A Cautionary Tale For Interviewers
You interviewed a remote candidate for a technical role who nailed it. The interview panel unanimously agreed to move forward, and the candidate skated through the new hire screening. You set them up on a project that fits their skillset perfectly, and you were excited for their first day. But when the candidate started, things seemed… off.
Reflecting On The Syneos Health Acquisition: The Due Diligence Imperative
Syneos Health made headlines when it announced it may soon be acquired by a private equity consortium for approximately $7.1 billion. This transaction represents an exciting opportunity for both parties, but it also underscores the importance of thorough due diligence to ensure that the acquiring party maximizes value from the target entity.