Not A Bad First Year

By Dan Schell, Chief Editor, Clinical Leader

I've been lucky.

A year ago I accepted the role of Chief Editor of Clinical Leader. I have not worked at a pharma company, CRO, or a clinical trial site. My exposure to the clinical trial industry was limited to what topics and articles we covered during the past 14 years in our sister publication Life Science Leader.

As I dove into learning everything I could about the clinical trials world, I was immediately drowned in a tidal wave of acronyms. I remember discovering Dan Sfera's podcast, and while listening to episodes, I would take notes about terms and acronyms that I would have to look up later to decipher. Slowly, I started to identify some of the key issues and hot topics people were talking about. LinkedIn also proved especially useful, and it was there that my luck started. Namely, I started requesting connections from the people I had seen commenting on posts and from various experts I listened to on numerous podcasts. And, they started accepting my connection requests. 

I continued to build my network at conferences such as Save Our Sites and SCOPE. I also tapped into the wealth of expertise that our Clinical Leader editorial board offered. Here are a few of the things I’ve learned over this past year:

• DCTs really upset some people at first. And now, not so much. They’ve just become one way of conducting trials, and they no longer are considered the bane of all sites.
• Everyone was on the DE&I bandwagon and had formed special groups/committees/departments to address this problem. Today, some of those groups have disappeared, and despite a lot of efforts to solve this age-old problem, it still dominates industry conversations. I’m confident, though, that the FDA’s new Guidance and the implementation of DAPs will start to move the needle on this problem.
• The fact that it typically takes sites months to get paid and the process is often mired in obfuscation is confounding to me — as I’m sure it is to sites. It’s another one of those, “well, it’s always been this way” situations that has to improve; it’s a serious threat to the advancement of this industry.  
• Integration is a big buzzword. Vendors need to integrate their platforms! Data needs to integrate so we can avoid silos! Consequently, we need to standardize! I love the enthusiasm, but I’m skeptical — especially of the vendor part. 
• CVS had already bailed, but Walgreens, Kroger, and Walmart were all touting their focus on clinical trials and how their giant swaths of neighborhood “sites” will revolutionize recruitment and drastically improve patient satisfaction. Any semblance of a revolution has yet to happen, although Walgreens is making strides with its BARDA contract.

Who Helped? I Mean … Who Hasn’t!

Below is a list of just a few of the people I have been fortunate to have worked with, and of whom, have made a big impact on myself and Clinical Leader during the past 12 months. There are tons of others, and I’m appreciative of you all. 

Tiffany Ashton — One of my earliest interviews, Tiffany set me straight on CRAs, CRCs, and CTMs — and how difficult their jobs can be. That interview was really pivotal for me in understanding what goes on at sites.

Denise Bronner — When I first met Denise she was still working at J&J, and she was contributing some great articles about diversity in clinical trials. Eventually she would leave Big Pharma to start her own consulting firm, and she eventually became a panelist along with Stacey Bledsoe at Gilead and Garo Kiledjian of the SGM Alliance for a Clinical Leader Live focused on diversity and clinical trials.

Vincent Cafiso — When Vin’s  “20 Things Never to Say to an FDA Investigator,” post blew up on LinkedIn, I reached out and asked him for an interview. The result was me learning a heck of a lot more about FDA inspections, which culminated in the article “Easy Mistakes To Make During An FDA Inspection.”

Dr. Daniel Fox — Dr. Fox is one of those guys who I could send a message to today with a stupid question, and he would quickly reply back with an answer that would make everything clear to me. He was a panelist on one of my Clinical Leader Lives this year, and he is a strong advocate for not only diversity with his DiversiTrials company but getting sites paid, and paid quicker, with his company CRPN.

Ross Jackson — Like a lot of people on this list, I first encountered Ross thanks to his LinkedIn posts where he's often wearing a tie in his video posts. He continues to be one of our regular contributors of content regarding patient recruitment and retention, and his articles consistently garner a lot of attention.

Lindsay Kehoe — As the senior project manager at Clinical Trials Transformation Initiative (CTTI), Lindsey does her fair share of attending conferences and being a speaker. So I was psyched to have her agree to be a panelist for my Clinical Leader Live on DCTs.

Micah Lieberman — The man behind the SCOPE conference, Micah helped connect me with a number of presenters at the 2024 Summit. One of those folks was Tom Dougherty of Pfizer who spoke about tokenization in clinical trials, which is still one of the most-read articles on our site.

Craig Lipset — Craig is a long-time supporter of Clinical Leader having worked with my predecessor Ed Miseta for many years and continues to serve our editorial board. With his focus on the DTRA, Craig has become my go-to resource for all things DCT-related.

Nicole Palmer — It's the bow ties. That's what first grabs your attention about Nicole, although if you watch any of her videos on LinkedIn, you'll see that her expertise lies in the TMF, and she was very patient with me in explaining the ins and outs of dealing with this important document.

Samir Shah — Having worked for CROs for 24 years, Samir has some strong opinions on how they are run and what the future is for their business model. He's been a great sounding board for me when it comes to questions regarding the FSP model, and we look forward to having him on our editorial board.

Jess Thompson — In recent months I've got to know Jess a little better thanks to two separate interviews I did with her. But I had met her at the SOS conference and followed her on LinkedIn all year. She's super knowledgeable, insightful, and fun — traits that you don't always find in a subject matter expert.

Ted Trafford — When Ted messaged me that he was disappointed we didn’t have a site voice on our Clinical Leader Live panel about feasibility, I decided to ask him to be a guinea pig on our first LinkedIn live, which was a follow up to the feasibility event. Since then, I’ve learned a lot from him by listening to his “Innovating Clinical Trials” podcast that he cohosts with Liam Eves.

I’d be remiss if I didn’t also thank my colleague and Clinical Leader Executive Editor Abby Proch for all her help and guidance this past year. Abby manages all the contributed content to our site, and as such, is the reason why you can always find such a plethora of new articles featuring insights from impressive experts throughout the clinical trials industry.

In 2025, I’m looking forward to meeting more of you in person, over a Teams call, on LinkedIn, or during one of our many Clinical Leader Live events. Please reach out and connect — and thank you for everything you do to contribute to the success of clinical trials.