GUEST COLUMNISTS

• Why Sponsors Should Obsess Over Clinical Trial Oversight

  Just in Time GCP Founder and CEO Donna Dorozinsky explores the importance of clinical trial oversight and what to expect for the future of clinical trial oversight.

• What Clinical Trial Information Do VCs And Investors Actually Want?

  To prepare for conversations with investors, biotechs should know the “who,” the “why,” and the “when” of their clinical trial setup. Experts from LongeVC explain.

• How Clinical Research Can Be A Path To Clinical Care For Minority Health

  BJEConsultants Chief Quality Officer Courtney Shihabuddin, DNP discusses how clinical research can be a pathway to clinical care for minority populations, specifically exploring care for minority women with breast cancer.

• Correct But Misleading: AI Hallucinations In Complex Decision-Making

  Managing risks associated with AI hallucinations requires "explainability," a process that identifies patterns or behaviors in AI models that are inconsistent with training data or logical expectations. Regulators are mandating transparency in AI models used for drug testing and development.

• Unveiling The Importance Of Negative Results In Clinical Trials

  BJEConsultants Chief Scientific Officer Bashar S. Shihabuddin, MD discusses negative clinical trial results and how they play a role in enhancing the generalizability of research findings.

• Clinical Trial Recruitment: Who Are You Paying And What Are You Saying?

  Who and what you pay — and what you say — matters for the success of a clinical program and from a compliance perspective.

• How Doubly Labeled Water Can Improve Data In Metabolic Disease Research

  Energy imbalance is at the root of metabolic disease, yet it isn’t being measured. The DLW method offers assesses total energy expenditure, energy intake, and body composition for clinical and research evaluations. 

• The Pros And Cons Of Synthetic Control Arms In Clinical Trials

  Harriet Gray Stephens, MFPM, medical director in the clinical and medical affairs team at Boyds, explores how synthetic control arms (SCAs) are being used in clinical trials, the views of regulators, and the advantages and limitations of SCAs in practice.