Clinical Guest Contributors
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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.
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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.
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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.
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FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions
4/11/2024
The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
4/9/2024
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
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ICH E6(R3) And Defining What Is Critical To TMF Quality
4/9/2024
By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).
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AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance
4/8/2024
The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.
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You’ve Chosen Your Vendor(s), But Have You Thought About Their Oversight?
4/8/2024
Vendor management has become an even more complex task involving multiple stakeholders, and it may often be overlooked, especially in the oversight of subcontracted vendors.
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New FDA Draft Guidance: Data Monitoring Committees In Clinical Trials
4/1/2024
In a new draft guidance, the FDA describes expectations of data monitoring committees in clinical trials. The public comment period ends April 15, 2024.
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FDA, MHRA, Health Canada Joint GCP Symposium Focuses On 3 Key Topics
3/27/2024
The FDA, the U.K. MHRA, and Health Canada recently came together for a symposium on GCP with focus on the ICH E6 harmonized guideline and two other key topics.