Central Laboratories Featured Articles
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Patients Need Faster Access To Approved FDA Vaccines. What Can We Do?
8/17/2023
There are times when a significant lag between the FDA approval of vaccines and the Centers for Disease Control and Prevention (CDC) recommendation of those vaccines throws any newly approved vaccines into patient access purgatory. What can vaccine developers do during the clinical trial phase, and what can other stakeholders do, to help influence a shorter lag?
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AI's Potential To Improve Clinical Operations, Trial Matching
8/11/2023
Microsoft's Dr. Hoifung Poon explains how AI (specifically, large language models) can be used to improve patient care and clinical workflows by making it easier to match patients to trials.
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How Blockchain Can Empower Patients And Improve Clinical Trials
8/4/2023
Blockchain is far bigger than cryptocurrency. It's a data encryption technology that can not only strengthen existing clinical systems, but also (and most importantly) empower patients by giving them more control and ownership of their clinical data.
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How Can Non-randomized RWE Studies Complement RCTs?
8/4/2023
While RWE can provide deep insights into the drug development process, inform regulatory decisions, and supplement clinical research, it does have its limitations. Researchers with the RCT-DUPLICATE Initiative have emerged with key learnings to further inform the industry on the capabilities of RWE.
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Designing Quality Into Your TMF: ICH E6(R3) And Advancing Trial Efficiency
7/17/2023
The May release of the International Council for Harmonization (ICH) draft guidance E6(R3) for public review and comment has inspired optimism that its implementation could lead to more efficient trials. Could implementation also improve trial master file (TMF) quality in support of greater efficiency?
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No More XPT? Piloting New Dataset-JSON For FDA Submissions
7/12/2023
CDISC has developed Dataset-JSON, a new dataset exchange format, to replace XPT. Working with the FDA and industry participants, CDISC and PHUSE are leading a new pilot project to test Dataset-JSON for use in regulatory submissions as well as other dataset exchange scenarios.
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Key Takeaways From The EU MDR Expert Panels’ First Published Scientific Opinions
7/10/2023
The EU's Medical Device Regulation, which entered into force in 2021, introduced new requirements for clinical and post-market data for medical devices in Europe. As an additional level of scrutiny for specific devices, the Clinical Evaluation Consultation Procedure ensures that notified bodies correctly assess the clinical data. Let's look at what we can learn from the expert panels' first published scientific opinions.
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Shared Knowledge & Shared Data Is Crucial To Developing Innovative Therapies For SCIs
7/7/2023
In this Q&A, Chief Science Officer Marco Baptista, Ph.D., discusses the Christopher & Dana Reeve Foundation's focus on and approach to data and knowledge sharing, as well as patient engagement, as it works to advocate for and fund the development of spinal cord injury (SCI) therapeutics.
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Using RWD For Rapid Signal Assessment: Current Gaps And Opportunities
6/23/2023
One of the chief benefits of applying RWD for rapid signal assessment is that it can provide a more accurate view of outcomes that should be expected within a given clinical scenario. However, before RWD’s maximum potential for rapid signal assessment can be reached, the industry must overcome some sizable challenges. Amgen's Vaishali Patadia explains.
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Safety-centric Monitoring: Measuring Safety Data In A Consistent And Standardized Manner
6/19/2023
Today, we have access to more data than ever before, and in an ever-advancing technological landscape, it is increasingly important to adopt a safety-centric monitoring approach that ensures we can measure safety data in real time and in a standardized manner across the industry. The challenge now is how to extract and leverage the quality data from the large volume that we have access to.