Dan Schell articles

31. Can Better Data Management Save Clinical Trials? 11/25/2024

    In this summary of our 10/31/24 Clinical Leader Live, we talk about the current ICH M11 guideline, which focuses on a clinical electronic harmonized protocol, as well as the need for data standardization and the benefits of the resulting automation. Our panelists include Jessica Jolly, a data science expert with 25 years of experience, and Hassan Kahlid, senior engineer, machine learning and data science at AstraZeneca.

32. PI Insights From A Heart Failure Trial: Part 2 11/19/2024

    This is part 2 of Dan Schell’s interview with Jennifer Cowger, MD, the co-principal investigator of the Abbott TEAM-HF clinical trial. Here, she elaborates more on some of her tasks specific to this heart failure trial. 

33. PI Insights From A Heart Failure Trial: Part 1 11/14/2024

    Jennifer Cowger, MD, the co-principal investigator of the Abbott TEAM-HF clinical trial, talks about her role as a PI including trial design and meetings with the FDA.

34. Not A Bad First Year 11/11/2024

    Dan Schell, chief Editor or Clinical Leader, summarizes his first year in this role and highlights some of his key takeaways and lists some of the people who have helped him better understand the clinical trials ecosystem. 

35. We Are All Project Managers, But We Need Help 11/1/2024

    Jess Thompson is a champion of project managers. Not only is she working to validate their role in the clinical trial ecosystem, she wants to spread the word that we all perform PM-types of duties. Also, if we could get better as an industry at incorporating some of those basic tenants of project management, perhaps we could see more drugs succeed — and quicker. 

36. Plodding Toward Better Data Integration & SSO 10/23/2024

    Laura Hilty, a principal at HealthX Ventures, talks about the need to better integrate data platforms and improve/enable single sign-on (SSO) solutions so sites can lessen their administrative burden.

37. A New Barometer For Clinical Outsourcing Performance 10/16/2024

    Interested in how some of the top publicly traded clinical development outsourcing companies are doing in the market? Andrew Schafer may be able to help with his Schafer Clinical Development Index (SCDI).

38. Want To Improve Study Startup? Get More Efficient 10/3/2024

    John McAdory, VP of ClinOPs at CG Oncology, recognizes that today’s clinical trial designs tend to be very complex, which complicates study startup. He says the key to improving this challenge is to find small ways to be more efficient throughout the process.  

39. AI Can't Help Bad ClinOps/Health Equity Data 9/25/2024

    Brian Johnson, Ph.D., VP, R&D Technology at Takeda discusses the huge opportunity of connecting disparate ClinOps data and leveraging generative AI to reduce costs and labor during the clinical process. 

40. Key Takeaways From Clinical Trial Diversity Discussion 9/24/2024

    During the Clinical Leader Live, The Diversity Mandate: Effective Strategies in Clinical Trials”, we discussed everything from the guidance, to diversity action plans, to the need for better data on race, ethnicity, and identity. In this article, we also share 25 questions audience members had regarding this hot topic.