In this issue of the journal, Jonathan Seltzer presents an important review of the rationale and best practices for event adjudication in medical device clinical trials. The concepts presented in this work are well aligned with Food and Drug Administration's (FDA's) expectations for an adjudication process that enhances clinical study quality.
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What You'll LearnMost Recent Flipbooks
The Most Important Voice Is Missing: The Case For Including Patient Insights In Protocol Design
Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk
Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk
The Power to Pivot: Decoding CNS Trials with Data Analytics
In this interview, Jesse Kooker, MPH, VP of Clinical Data Sciences at WCG's MedAvante-ProPhase, looks at the clinical development industry through the lens of data analytics.
Site-specific, Patient-centered and Whip-smart: Enrollment Assistants Adapt to a Shifting Landscape
In this paper, 17 WCG thought-leaders provide insights on what they anticipate in 2019 in clinical trial technology, regulatory changes, and scientific developments.
Addressing Suggestibility as a Psychological Phenomenon in Clinical Trials
It is important to understand patient perspectives and to anticipate how subjects in research studies may be impacted by the presence of digital tools, devices, and mobile health applications
Finding New Solutions to a Current Unsustainable Model of Clinical Trial Contracts & Budgets
Genetic Counselors at the Forefront of Helping Researchers Brace for the "Silver Tsunami" of CNS Disorders
An aging population is triggering a “silver tsunami” of neurodegenerative diseases like Alzheimer’s and Parkinson. At the same time, precision medicine holds great promise for many CNS disorders.
Precision Medicine: A Glossary of Terms
As genetic testing becomes an integral part of clinical development programs, understanding the key terms and definitions is essential for all members of research and clinical development teams.
Studies show clinical trial participants want to know what was learned from their involvement. Many sponsors are implementing plans to deliver plain language summaries to trial participants.
Written Procedures for IRBs: What Does the New Final Guidance from FDA and OHRP Mean to You?