Dan Schell articles

1. Should You Choose An FSP Model? It Depends… 1/10/2025

   Small biotechs are often drawn to an FSP model because they believe it’s a less expensive option as compared to an FSO. But that’s not always the case, says Réne Stephens of Danforth Advisors, who gives some examples of what to consider before making your choice of outsourcing solution.

2. Should We Be Scared Of PE Firms Investing In Sites? 12/16/2024

   It seems lately there's been a lot of vilification of private equity (PE) firms that are purchasing site networks. I'm sure this sentiment has increased during the past few years, but is it justified? 

3. Let's Fix The Tax Burden On Clinical Trial Participants 12/10/2024

   We all know that patient retention is lowered once a participant realizes the tax implications of being in a clinical trial. But taxes should be the last thing they have to worry about, so why can’t we get some changes made? 

4. Were There Any Surprises In Clinical Trials In 2024? 12/4/2024

   Is it any surprise that when I asked a group of clinical trial industry experts to summarize some of the things that stood out to them in 2024, that AI would be mentioned more than once? Probably not. Resistance to DCTs, increasing regulatory scrutiny, and a slowdown in CRO M&As also made their lists — but I’m guessing none of that surprises you, either.

5. 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.

6. 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.

7. 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. 

8. 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.

9. 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. 

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.