Clinical Guest Contributors
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Trends In FDA FY2023 Inspection-Based Warning Letters
2/13/2024
The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.
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Addressing Underrepresentation In Cancer Trials: A Q&A With Stand Up To Cancer & Triage Cancer
2/13/2024
Clinical Leader heard from both sides of the collaboration — SU2C researcher Dr. Chanita Hughes-Halbert, Ph.D., and grant recipient Triage Cancer co-founder and COO Monica Fawzy Bryant, Esq. — to explore each’s efforts to together bring health equity to those diagnosed with cancer.
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Strategies For Seeking Multiregional Regulatory Approval
2/12/2024
Consultant Peter Embley discusses the importance of developing a regulatory strategy (RS) that intends to support both U.S. and EU regulatory approval.
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FDA Guidance On Standardizing Diversity And Inclusion Terminology And Collection
2/9/2024
Last week, the FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.
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9 Ways Unified Clinical Data Cloud Platforms Solve Data Challenges In Rare Disease
2/8/2024
A unified clinical data cloud platform is a data and analytics platform that contains a data hub to aggregate clinical data from multiple data sources and in multiple formats — and it could be the cure for disordered rare disease data.
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Transforming Clinical Trials For Women In 2024
2/7/2024
Change is long overdue, and it begins with a fundamental shift in how we design clinical trials, placing women's perspectives and needs at the core of planning and implementation.
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3 Areas Where AI Could Revolutionize Patient Recruitment And Retention
2/6/2024
Explore three ways in which AI can make a positive impact on patient recruitment and retention, as identified by life sciences consultant Ross Jackson.
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Why Pharmas/Biotechs Should Champion Non-Pharmaceutical Interventions For MDR Pathogens
2/5/2024
Multi-drug resistant (MDR) pathogens are an escalating concern. While the primary focus of MDR pathogen treatment strategies has revolved around the creation of innovative therapeutics, diagnostic tools, and antibiotic stewardship, there has been a limited emphasis on implementing non-pharmaceutical interventions (NPIs). Regardless of what indication your drug's clinical trial is investigating, implementing NPIs will actually help your trial be more successful.
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Incorporating SOGI Data In Clinical Research And Impacts On Enhancing Cancer Treatment Outcomes
2/2/2024
Collecting and measuring SOGI information in cancer care and clinical trials is critical to ensuring equitable and effective care for all individuals.
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4 Things I’m Looking Forward To At SCOPE 2024
2/1/2024
The Summit for Clinical Ops Executives (SCOPE) begins Feb. 11. Discover four things Executive Editor Abby Proch is looking forward to at the annual event.