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Building 66, located at the FDA White Oak Campus in Silver Spring, Maryland, is a pivotal facility for the U.S. Food and Drug Administration (FDA). It houses explicitly the Center for Devices and Radiological Health (CDRH). This building is part of a larger campus that embodies the FDA’s commitment to operational excellence and scientific advancement in public health.

The Clinical Data Interchange Standards Consortium (CDISC) is a global nonprofit organization that is pivotal in standardizing clinical research data. Founded in 1997, CDISC aims to develop and promote data standards that enhance the efficiency of clinical trial data collection, analysis, and submission. This comprehensive post will delve into CDISC’s structure, standards, and impact on clinical research, regulatory submissions, and the broader healthcare landscape.

In today’s competitive clinical trial landscape, CROs are indispensable. They help sponsors manage the complexities of trial protocols, patient recruitment, and stringent safety standards. Several CROs have emerged as leaders, with the global clinical trials market growing rapidly. Below, we explore the 10 largest CROs, highlighting their strengths, global reach, and contributions to clinical research. 

Don't miss out on a fantastic chance to participate in the hybrid 2023 International Conference on Pharmacoepidemiology. Esteemed specialists in the field will delve into the realm of Advancing Pharmacoepidemiology and Real-World Evidence for the Global Community.

Inclusion criteria are important in clinical trials because they define the specific characteristics and eligibility requirements that potential participants must meet to be included in the study. This helps to ensure the safety of participants, the validity of study results, and the ethical conduct of the trial.

In a clinical trial, a composite endpoint combines two or more individual endpoints (also known as component endpoints) into a single, combined outcome measure. The purpose of creating a composite endpoint is to provide a more comprehensive assessment of the treatment effect and to capture multiple clinically relevant events that may occur during the study. Composite endpoints can also play essential roles in providing statistical power to the study.

A Data Safety Monitoring Board (DSMB), also known as a Data Monitoring Committee (DMC) or Independent Data Monitoring Committee (IDMC), is an independent group of experts responsible for monitoring the safety and efficacy of a clinical trial while it is ongoing. The primary role of the DSMB is to ensure the well-being of study participants and to maintain the scientific integrity of the trial.

In the rapidly evolving field of medical devices, software plays a critical role in enhancing their functionality and performance. As the demand for innovative healthcare solutions continues to rise, regulatory bodies such as the U.S. Food and Drug Administration (FDA) have established guidelines to ensure the safety and effectiveness of medical device software. In this blog post, we will explore the content of premarket submissions for device software functions, shedding light on the essential aspects Companies must consider when seeking regulatory clearance.

Clinical trials are relevant to demonstrate the safety and performance of Medical Devices, and the design of a clinical study can be [statistical] art on its own. Not only is it essential that the trial will be viable, but there is also often the uncertainty of it being accepted as sufficient by the regulatory authorities.

A proposed FDA regulation has been published, requesting public comments, to modify the existing requirements of the Quality System (QS) regulation (21 CFR Part 820) for medical device quality management to incorporate the international standard AND address the needs of medical devices manufacturers. The proposed regulation, if approved, would help to harmonize the U.S. requirements for QMS with the requirements of the International Organization for Standardization (ISO).

In this article, Biomedical Statistical Consulting's (BSC) Biostatistician Brendan Keenan and co-authors confirmed a previously unreported gene affecting sleep duration in mouse models.

In this article, Biomedical Statistical Consulting's (BSC) Statistical Analyst Alex Ginev and co-authors investigated the effect of a transition in EHR on the patient experience through an instrument examining interactions with nurses and providers.

BSC's Principal Statistician and UPenn Professor Greg Maislin coauthored two recent studies!

The first, the authors find evidence supporting strong heritability of spindles although not all spindle characteristics are equally heritable. The second Analysis of t

A recent paper by Brendan Keenan was published in G3: Genes | Genomes | Genetics highlighting that fat-distributions are heritable in eight founder strains mouse models. The study used magnetic resonance imaging (MRI) protocols and dimension reduction through principal component analysis (PCA).

The March 2021 publication of the Journal of Orthopaedic Trauma includes a rich set of information regarding the use of Real-World Data (RWD) focused on the Bioventus Observational Noninterventional EXOGEN Studies (BONES) Program.

BSC team members David Maislin and Brendan Keenan supported Dr. Victoria Pak (Emory University) in two abstracts examining the impact of CPAP on inflammatory biomarkers and whether obesity modifies the effect.

Does sleep apnea affect heart rate variability during wakefulness?

Obstructive sleep apnea (OSA) is a common sleep disorder associated with increased cardiovascular disease risk. However, the relationship between OSA severity and multiple heart rate variability (HRV) metrics during wakefulness remains an open question.

We are happy to announce that another article has been published by two of our BSC team. Well done, David and Brendan, and UPenn collaborators.

The article shows the effect of Obstructive Sleep Apnea and Positive Airway Pressure Therapy on cardiac remodeling in Nonobese and Obese Adults.

Do you know that many aspects of sleep and circadian behavior are heritable both in humans and mice?

In this new article, Brendan Keenan in collaboration with the School of Medicine, University of Pennsylvania has published an article on high-throughput phenotyping strategies for sleep and circadian behavior in mice, including examinations of robustness, reliability, and heritability among Diversity Outbred (DO) mice in the Sleep Research Society.

This was an excellent Continuing Medical Education (CME) presentation given by Allan Pack and & Greg Maislin at the Behavioral Sleep Medicine Seminar Series provided by the University of Arizona College of Medicine Tucson.

One of the areas of our expertise is Obstructive Sleep Apnea (OSA). Brendan Keenan was lead author on this article evaluating a diagnostic code-based algorithm for identifying cases of diagnosed OSA.

In the article, the authors propose that Propensity Score designs are the optimal approach to address the impact of continuous positive airway pressure (CPAP) on cardiovascular events.

BSC Founder and University of Pennsylvania professor Greg Maislin participated in the 25th Congress of the European Sleep Research Society (ESRS) 2020.

BSC Associate Statistician David Maislin co-authored a paper in Quantitative Imaging in Medicine and Surgery on “Implant placement accuracy in total knee arthroplasty; validation of CT-based measurement technique.” The researchers found that the measurement technique they studied can be used in applications where measurement errors of up to 0.9 mm in translations and up to 0.6° in rotations in component placement are acceptable.

BSC Founder Greg Maslin was invited to share his thoughts about medical devices, Bayesian analysis and the FDA on the Pod of Asclepius, a healthcare technology podcast named for the Greek god of medicine and doctors. He joined the FDA’s Martin Ho and host Glen Wright Colopy to talk about issues important to the American Statistical Association’s Section on Medical Devices and Diagnostics.

BSC Founder Greg Maislin participated in three of the FDA’s last three orthopedic panels, which reviewed the Barricaid annular closure device, the Cartiva Synthetic Cartilage Implant, and the Vertiflex Superion Implant.