Industry Insights
-
$100m In Government Funding Helps, But What Can Really Be Done About Trial Diversity?
4/18/2024
Monique Gary, medical director of the Grand View Health cancer program, lists three steps to take right now to improve clinical trial patient diversity.
-
Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024
4/17/2024
This article outlines key FDA regulatory developments from the past few months relevant to sponsors seeking approval of cell and gene therapies in the U.S.
-
How To Determine Country Feasibility For Cell And Gene Therapy Clinical Trials
4/17/2024
Learn how to choose the right location — globally — for your next cell and gene therapy clinical trial.
-
Shorter, Faster, Cheaper: Powerful New Data On Digital Endpoints
4/16/2024
The idea of leveraging novel, sensor-based measures to gather data for clinical trials is not new, but relevant evidence of their usefulness is. Here, DiMe experts discuss the impact of digital endpoints on trial success.
-
Should You Bring Your Trial Master File In-House?
4/15/2024
The decision to bring the TMF in-house or contract with a CRO depends on the specific needs and resources of the sponsor, and it is important to carefully consider the implications before making a decision.
-
FDA’s Updated Draft Guidance On Reporting Of Diversity Data
4/15/2024
To ensure the safety and effectiveness of medical products for different populations, learn how the FDA is standardizing data collection and reporting for all new clinical trials and studies.
-
Next Generation Of Clinical Monitoring | Part 2: Detecting Clinical Trial Fraud & Misconduct
4/15/2024
Discover how modern data and surveillance technologies revolutionize the detection of clinical trial fraud and misconduct in the evolving landscape of clinical monitoring.
-
Looking Back & Moving Forward With J&J’s Global Development Leader For Immunology
4/15/2024
In this Q&A, David Gordon, M.B., Ch.B. recounts lessons learned from past clinical trial challenges and shares current-day strategies, like figuring out how to run a study that’s both scientifically sound and actually doable for patients and doctors.
-
Mission: Remission — Patient Need For Durable Treatment Informs J&J’s Ulcerative Colitis Trial
4/15/2024
J&J Global Therapeutic Area Head, Immunology, David M. Lee, MD, Ph.D., talks about the progression from treating PsO and PsA to UC, the importance of integrating patient needs into the trial’s design, and the quest for a durable treatment that lends itself to total remission.
-
EMA’S eCTD 4.0 Workshop Seeks To Gear Industry For Implementation
4/12/2024
As the EU prepares to implement the new eCTD 4.0 standard for regulatory submissions, the European Medicines Agency (EMA) is taking steps to ensure a smooth transition for industry.