Protocol Design Featured Articles

  1. How Did Clinical Researchers Actually Use AI In 2024? 12/5/2024

    Looking ahead to 2025, Clinical Leader seeks to understand how clinical research professionals are incorporating AI into their work. So we asked them, “Simply put: Are you using any iteration of AI in your role within clinical research? If so, how and why?”

  2. Top 4 Trends For Neuropsychiatric Disease Research In 2025 12/3/2024

    Arrivo BioVentures' Kelly Abernathy and Joel Raskin, MD identify what they think will be the top four trends in neuropsychiatric disease research in the new year.

  3. 2024: Familiar Problems & Encouraging Progress 11/27/2024

    For part 1 of my 2024 recap, I asked various industry experts what stood out to them this year regarding the clinical trials industry. They mentioned significant challenges related to site capacity, enrollment, workforce changes, and trial complexity, but they also seemed encouraged with some of the efforts and emerging solutions that will address these issues.

  4. UCB Emphasizes Importance Of Patient-Centric Protocols 11/19/2024

    UCB Global Medical Head of Immunology John Ioannou emphasizes the need to partner with the healthcare community, supporting medical and patient organizations, but most importantly, patients to advance the design and execution of patient-centric clinical trials.

  5. 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. 

  6. 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.

  7. Scaling Gene Therapy Clinical Trials Through The Lens Of Ophthalmology 11/14/2024

    Ocugen CMO Huma Qamar, MD, MPH, CMI discusses scaling gene therapy clinical trials with special attention paid to logistical planning, collaboration with specialized centers, and managing future manufacturing needs.

  8. The One-And-Done Investigator: A Clinical Trial Story 11/13/2024

    There are too many one-and-done principal investigators in clinical research — at least that's the common refrain. But Paul Ivsin isn't convinced. Here, Ivsin looks into and discusses the supposed one-and-done PI crisis.

  9. Call To Include More Pregnant And Breastfeeding Women In Research 11/12/2024

    In this Q&A, UCB Global Head, Women of Childbearing Age Program Marie Teil reiterates the importance of including women of childbearing age, including pregnant and breastfeding women, in clinical research and explains why it’s a priority for UCB.

  10. 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.