Articles By Dan Schell, Chief Editor
DAN SCHELL ARTICLES
Do We Still Need To "Save" Our Sites?
Budget negotiations, sponsor expectations, operational pressures, and burnout all remained front-and-center concerns at this year's Save Our Sites (SOS) conference. In this recap, I share key takeaways from the sessions I attended — including practical budgeting advice, sponsor “turn-offs,” and a few unbelievable (but true) sponsor horror stories — along with why gatherings like SOS still matter for the site community.
Continue Reading..
Why Africa Could Be The Next Frontier For Clinical Trials
Africa hosts only about 3% of global clinical trials despite representing roughly 20% of the world’s population. Tariro Makadzange, founder and CEO of the Africa Clinical Research Network (ACRN), explains how the organization aims to build a continent-wide clinical trial platform and increase that share to 15% over the next decade.
Continue Reading..
How Keenova Reignited A Stalled Trial
When a difficult-to-enroll Phase 3 study stalled, Keenova found momentum not through new technology but through relationships, collaboration, and fair site support. By listening to site feedback, rethinking communication, empowering peer learning, and revisiting compensation, the team transformed engagement and enrollment.
Continue Reading..
Tekton's CEO On The Growing Power Of Site Networks
Site networks continue to gain momentum as organizations emphasize operational consistency, shared infrastructure, and scale. Tekton Research CEO Corey Collins discusses how collaboration, sponsor dialogue, and real-world pressures like recruitment challenges and study delays are shaping the model — while it remains too early to know whether network-scale approaches will deliver meaningful efficiencies for sponsors.
Continue Reading..
Say It Loud: Clinical Research Needs New Voices
At SCOPE, I caught up with Denali Rose, co-host of the Note to File podcast, to talk about why clinical research still struggles to communicate — and why that has to change. She’s pushing for more honest conversations and new voices across sponsors, sites, and vendors, and while progress is slow, she sees signs the silos are finally starting to crack.
Continue Reading..
Site-Centric First, Patient-Centric Always
At the 2026 SCOPE Summit, Boehringer Ingelheim’s Wouter Daniels argued that true patient centricity begins with site centricity. Daniels shared how Boehringer’s engagement efforts have accelerated studies by months and saved millions — proof that patient focus delivers measurable business and operational value.
Continue Reading..
Clinical Trials Need Fewer Barriers And More Humans
At the SCOPE Summit, Tina Karunaratne and Elizabeth Tabor discussed the gaps that still limit clinical trial access — from patient navigation and education to the need for real human support alongside AI tools. They also highlighted the importance of networking, professional visibility, and moving beyond conference talking points to actionable solutions that connect both patients and the people who make research possible.
Continue Reading..
Forget More Clinical Tech, We Need More Adoption
At SCOPE Summit, Craig Lipset shared a blunt assessment of clinical trial innovation: the tools exist, regulators are engaged, and digital approaches offer clear quality advantages — yet adoption remains the industry’s biggest hurdle. From evolving FDA inspection expectations to the normalization (and lingering misconceptions) of decentralized trials, Lipset argues progress will depend less on new technology and more on scaling what...
Continue Reading..
Joe Dustin: Sites Are Driving Clinical Tech Evolution
At SCOPE Summit 2026, Joe Dustin shared why clinical trial sites are emerging as the next drivers of innovation. As sites digitize operations and push back against the burden of sponsor-mandated systems, new models like “bring your own technology” and seamless digital data flow aim to reduce duplication, speed startup, and improve both coordinator and patient experiences.
Continue Reading..
AI Trial Matching Comes Of Age At City Of Hope
City of Hope has embedded an internally trained AI platform into oncology care and research workflows, helping clinicians summarize complex patient histories and match patients to clinical trials in real time. By reducing manual review and accelerating feasibility assessments across its national network, the system is improving trial access, easing clinician workload, and shifting more time back to patient care.
Continue Reading..
SCOPE Takeaways On Inclusion And Real Patient-Centricity
At SCOPE 2026, two panels made the same point from different angles: the industry understands the barriers to broader recruitment. The real challenge is execution. From embedding inclusion into protocol governance to rethinking recruitability and retention, the message was clear — access will only accelerate innovation if inclusion is built into the system from day one.
Continue Reading..
My SCOPE Groundhog Day Experience
From feasibility inefficiencies to overdesigned trials and overloaded investigative sites, the conversations at SCOPE were thoughtful and candid. The problem isn’t ignorance. It’s execution. Until simplification shows up in shorter timelines, leaner protocols, and measurable relief for sites, we may continue gathering each year to discuss the same issues — with the same data.
Continue Reading..
Informed Consent Isn't Broken — But It's Barely Working
Former FDA Commissioner Dr. Robert Califf has been blunt about what’s wrong with informed consent in clinical trials. In this article, we offer a high-level look at his three-part Substack series, exploring how consent became more about legal protection than patient understanding — and what needs to change.
Continue Reading..
Why Dr. Robert Califf Isn't Pulling His Punches Anymore
In this exclusive video interview, former FDA commissioner Robert Califf, MD reflects on quality, risk aversion, misinformation, and why clinical trials need sharper focus — not more data.
Continue Reading..
Choosing Clinical Research … On Purpose
Most clinical research careers begin by accident. Rutgers University is trying to change that with formal training programs designed for today’s academic and industry trial environments. Barbara Tafuto, Ph.D., interim program director of the Master’s in Clinical Research Management program at Rutgers University, explains the program’s genesis and potential impact on the industry.
Continue Reading..
When Clinical Trials Don't Stop For War
When war halted clinical trials in Ukraine, sites adapted instead of shutting down. Dr. Anna Titkova explains how patients, investigators, and sponsors kept research moving when conditions were anything but stable.
Continue Reading..
The Case For Research-Naive PIs
Carrie Lewis, executive director, clinical program optimization, at Keenova (formerly Endo) explains why research-naive PIs may improve trial quality, challenge assumptions about ROI, and help fix a shrinking investigator pipeline.
Continue Reading..
The Hidden Work That Keeps AMC Trials Moving
After a chance LinkedIn connection led to a conversation with Paul Antaby of MD Anderson, I got an inside look at how clinical trials really operate inside a major academic medical center. From material transfer agreements and data governance to recruitment, scale, and CRC burnout, this interview reveals the hidden work that keeps AMC trials moving — and why they operate so differently from community sites.
Continue Reading..
2 Expectations & 2 Warnings For The Year Ahead
Just when I thought I was done with 2026 predictions for the clinical trial industry, three members of my editorial board emailed me some great ones, hence, part 3 of this series. What’s interesting is that two of these submissions, coincidentally, are focused on optimism for AI. In contrast, Denise Bronner’s forecast for the coming year is much more … well, dire.
Continue Reading..
More 2026 Clinical Predictions
Part 2 of this 2026 forecast series dives deeper into the operational friction points the clinical trials industry still hasn’t resolved. Industry leaders weigh in on sponsor–site partnerships under strain, the growing tech burden on sites, consolidation across site networks and platforms, the limits of AI hype, and why human connection may end up being the most important “innovation” of all.
Continue Reading..
2026 Forecasts From People Smarter Than Me – Part 1
In Part 1 of this forecast series, leaders from TransCelerate, Genentech, Clinical Performance Partners, Marketcap Consulting, and others weigh in on what’s coming next — from regulatory pressure and RBQM mandates to BYOT momentum, AI reality checks, and the financial rebound many CROs are betting on.
Continue Reading..
Why HEOR Keeps Arriving Too Late — And How ClinOps Can Fix It
Rob Abbott, CEO of ISPOR, breaks down why HEOR timing keeps clashing with ClinOps timelines and offers practical ways to integrate value, evidence, and payer expectations much earlier in development.
Continue Reading..
Why Feasibility Still Feels Broken
During an interview with Dresden Whitehead of Avacare Clinical Research Network, her take on feasibility mirrored concerns raised during a 2024 Clinical Leader Live (CLL) webinar. She highlighted repetitive questionnaires, unclear sponsor expectations, and the challenges new investigators face. Combined with insights from the CLL discussion, the article explains why feasibility remains a persistent industry pain point.
Continue Reading..
Site Payments Are Still a Mess, But Takeda Is Trying To Help
In this article, Heidi Barham, Takeda’s associate director of clinical study site payments, explains how the company is replacing opaque CRO-driven processes with real-time transparency, streamlined startup payments, and a dedicated sponsor-side team that sites can actually reach.
Continue Reading..
Turning Site-Centric From Slogan To Reality
SCRS’s Collaborate Forward initiative aims to move “site-centricity” from industry buzzword to operational reality. By documenting how sponsors, CROs, and technology providers are improving feasibility, budgeting, contracting, and patient recruitment through measurable collaboration practices, SCRS is working to provide the industry with a playbook for better site relationships and trial execution.
Continue Reading..
Two Former FDA Chiefs, Two Very Different Warnings
Former FDA Commissioners Scott Gottlieb and Robert Califf are sounding alarms from opposite ends of the industry. Gottlieb warns that a leaner, under-resourced FDA will make life harder for clinical operations, while Califf argues the deeper failure lies in a healthcare system that’s forgotten how to learn from itself. Together, they paint a sobering picture of what’s really broken in clinical research — and why fixing it will...
Continue Reading..
Funding Diversity Where It Starts — At The Site
After crossing paths with retired family physician and researcher Dr. Bryce Palchick at two conferences, I learned about ACRO’s new Diversity & Inclusion Site Resource Grants Program — an effort funding community sites like Bryce’s to make trial diversity more than a buzzword by supporting real, grassroots engagement.
Continue Reading..
FDA Vs. MHRA Vs. EMA: Differences In Externally Controlled Trials
As the FDA, MHRA, and EMA release draft frameworks on externally controlled trials, sponsors face differing expectations. The U.K. leans pragmatic, the U.S. remains cautious, and Europe’s guidance is still evolving — leaving global trial planners to navigate regulatory gray zones.
Continue Reading..
Clinical Trials At A Crossroads
At DPHARM 2025, McKinsey’s Gaurav Agrawal warned that while clinical science is accelerating, trial operations aren’t keeping pace. He outlined a vision for 2035 built on scaling AI, expanding site ecosystems, and bringing trials closer to everyday patient care.
Continue Reading..
Inside A Micro-CRO's Evolution
A new generation of micro-CROs is emerging—lean, virtual, and built by experienced ClinOps leaders. Instead of owning infrastructure, they’re renting it, showing that credibility and connections can rival size in today’s contract research market.
Continue Reading..
Dan Schell
Click here to e-mail Dan
Since 2024, Dan Schell has been Chief Editor of Clinical Leader, a website focused on topics related to clinical trial operations. He also hosts multiple Clinical Leader Live webinars each year on topics such as AI use in clinical trials, regulatory shifts in clinical research, and diversity in patient recruitment. Previously, he served as the Editorial Director of Life Science Leader magazine, another Life Science Connect community, for 14 years. He has experience as a technology writer and worked for 10 years in hospital business development and communications.