Innovating Clinical Trials

In Part 2 of this three-part conversation, Liam and Ted continue their discussion with Duncan, President at DTS Language Services about patient trust, consistency, and the operational realities of translating clinical trial content. 

Duncan explains how small issues, from inconsistent terminology to differences in date formats, can undermine a patient’s confidence in a study and even lead to missed visits. Trust comes from consistency, fewer handoffs, and an approach that fits the purpose of the content, and describes the “quilt factor” that builds up when previous translations, multiple CROs, and competing terminology databases pile on top of each ot...

In Part 1 of this three-part conversation, Liam and Ted sit down with Duncan, President at DTS Language Services, to talk about the good, the bad, and the ugly of clinical trial translation. Drawing on experience in both pharmaceutical and language services, Duncan explains why translation is far more than converting words from one language to another, and why a mistranslation in a clinical study isn’t just a typo but a potential risk to a patient, a trial, or a regulatory submission.

Duncan explains why the real work of translation starts before the translation itself: understanding who is...

In this episode, Ted introduces the “ENROLL Corporation” (Everyone Needed for Recruitment Optimization Leadership and Logistics) an imaginary joint venture owned by the sponsor, the CRO, every site, and every vendor. He explains why most recruitment providers solve one small piece of the problem, much like a wildlife photographer so focused through a 500mm lens that an animal wanders past unnoticed. 

Liam adds a river analogy about who “eats their own cooking,” and together they look at the 80-plus factors that affect recruitment, the holes in the enrollment funnel that nobody measures, and how adding complexity to a protoco...

In Part 2, Robin Piazza, Liam and Ted get specific about what good safety oversight actually looks like in practice,  and what sponsors are getting wrong under the shift from FDA 2024 guidance to the stricter ICH E6 R3 standard. 

We explore:

- FDA 2024 guidance vs. ICH E6 R3: why global studies need one uniform plan
- Why a DMC charter is a “how the DMC will operate," not evidence, and is what inspectors actually want to see, and whether the charter was followed.
- The hidden conflict when the same experienced DMC member sits on m...

Robin Piazza reached out to us directly with this topic suggestion, and we’re glad she did. In Part 1 of this two-part conversation, Liam and Ted sit down with Robin, Founder of Sapiens GC, who spent over 20 years building and running the industry’s first commercial data monitoring committee service before going independent. She breaks down what a data safety monitoring committee actually does, where sponsors, CROs, and vendors each fall short, and why having one independent, unblinded party in the room can make or break a study’s compliance. 

We explore:

- Why safety oversig...

In this episode, Liam and Ted ask a simple “what if”, what if the industry took the time to really listen? 

Ted starts with a study startup delay that looks like a tooling problem but turns out to be a relationship problem. While Liam shares what happened when he pulled a frontline team member into a leadership meeting and found a patient-flow blocker that had backed up a 120-patient-a-day site for days.

They talk about why most trial meetings leave no room for problem-solving or relationship-building, why no one truly owns enrollment, and why the simpl...

Each episode in this series has built toward this one: what does all of this look like from the other side of the table? 

In the final part of this series, the Steve Wimmer shares his experince participating in several clinical trials himself, including one he screen-failed out of, and shares what that experience actually taught him about consent, communication, and being left in the dark. Liam and Ted add their own stories of trying to get into a trial as ordinary, motivated patients and being met with silence from both the sponsor and the site.  

Part 1 was about why storytelling matters, part 2 is about how to actually operationalize it and Steve Wimmer brings a framework that reframes the entire recruitment funnel. Every interaction a patient has, from the first ad to the first phone call, is either a trust deposit or a trust withdrawal. Miss that, and the best story in the world won't save a campaign that confuses people the moment they land on a website. 

Steve Wimmer, Liam Eves, and Ted Trafford move from why storytelling matters to how to actually build a recruitment engine around it. Steve introduces a f...

Liam and Ted sit down with Steve Wimmer, who brings seven years of direct-to-patient recruitment advertising experience. They discuss why storytelling in clinical trial recruitment isn't about writing something clever, it's about connecting an ad, a landing page, and a first site visit to something a real person can recognize as their own life

The conversation also tackles a myth sponsors carry into every IRB submission: that regulators are the ones saying no. Steve's experience says otherwise and the story of the "silly dinosaur image" that outperformed every carefully considered alternative in the portfolio makes the case...

In the final part of this three-part conversation, Liam and Ted close things out with Scott Burgher, Director of Patient Operations at Quest Diagnostics, looking ahead at where AI genuinely moves the needle in recruitment, and where the industry still gets feasibility wrong.

Scott breaks AI's near-term impact into two practical buckets. The first is administrative: compressing study startup from six to twelve months down to weeks by automating document collection, regulatory submissions, IRB correspondence, and budget negotiations, work that's repetitive by nature and ripe for automation. The second is data-driven: using EHR and lab data to...

In Part 2 of this three-part conversation, Liam and Ted continue with Scott Burgher, Director of Patient Operations at Quest Diagnostics, going deeper into why recruitment keeps falling short.

Liam reframes the problem from the ground up: the industry treats recruitment as a marketing function obsessed with filling the top of the funnel, when the real work is moving patients all the way through it. Scott connects this to his experience running end-to-end mock trials years ago, testing the full patient journey, not just whether an ad worked, but whether someone could realistically sit through a four-hour infusion...

In Part 1 of this three-part conversation, Liam and Ted sit down with Scott Burgher, Director of Patient Operations at Quest Diagnostics, who brings over 20 years of patient recruitment experience spanning healthcare marketing, clinical trial agencies, large consulting, and big tech, to talk about the good, the bad, and the ugly of patient recruitment.

In this episode, Scott breaks down why recruitment keeps missing the mark. He argues that sponsor decision-making cycles are a massively underestimated blocker, a recruitment strategy can be fully approved by the study team and still sit untouched in legal or procurement for months...

In this special episode, we mark Ted Trafford's 31st year in clinical trials with a candid reflection on what three decades in this industry actually teaches you.

It started with a LinkedIn post Ted wrote where is says that after 31 years, he said he'd learned nothing. Listen in to hear what he meant by this. Liam and Ted go on to discuss the more experience you accumulate, the more you realise how much you still don't know. Liam frames this through the circle of competence: as your knowledge grows, so does your awareness of everything sitting outside...

Every trial starts with a number on a slide,  patients needed, months allotted, a clean straight line on a chart. 

Liam and Ted pull that line apart in this episode, starting with Lasagna's Law: the 1970s observation that eligible patients seem to vanish the moment a trial opens and reappear the moment it closes. They dig into why recruitment forecasts go wrong not because the math is bad, but because the assumptions underneath the math are never tested, tracked, or even written down. 

Liam reframes recruitment forecasting using a sat-nav analogy: the plan is your est...

In this episode, Ted  opens with a poem that captures the persistent, compounding burden on clinical trial sites: 50-page consents, non-functional tech, poached CRCs, financial holdbacks, and study designs that ask far too much from participants for far too little payoff.

What follows is a candid conversation between Ted and Liam about why these problems haven't gone away and in many cases, have gotten worse. Study visits in 2026 take twice as long as a decade ago. One in three procedures collected don't support a primary or key secondary endpoint. Endpoints, procedures, and planned visits have each grown b...

In this episode, Liam and Ted explore one of the most underexamined problems in clinical trial recruitment: patient motivation is not static. 

Drawing on real-world experience from a late-night participant funnel audit to an insomnia study no-show Liam introduces two interconnected frameworks: the Decision Threshold Matrix and the Trial Value Equation.

The matrix maps patient motivation across four quadrants defined by disease severity and perceived treatment adequacy. It breaks down how patients unconsciously calculate whether participation is worth it and why trial teams consistently inflate the denominator (burden) without strengthening the numerator (benefit). 

To...

In the final episode of our three-part series with Jill Fikowski, founder and CEO of Changemark Research + Evaluation, we get into one of the most persistent problems in clinical research: retention.

Jill unpacks why participants drop out and it's rarely what sponsors assume.  From there, we get into the pressure that lands on research coordinators when enrollment is behind, the practices that pressure produces. We also look at what happens after the last visit particularly in psychedelic trials and whether researchers have a responsibility that doesn't end when the database closes.

Retention problems, Jill argues, a...

In Part 2 of our conversation with Jill Fikowski, founder and CEO of Changemark Research + Evaluation, we get into what good community engagement actually looks like in practice not as a checkbox, but as a core design principle.

Jill opens with a clear answer to what good looks like: involve community from the very beginning and not just at the consent stage, not just in an advisory board email, but in protocol design, recruitment strategy, and how findings are shared.

Jill walks us through a Quebec youth cannabis and psychosis study that surpassed both its enrollment...

Jill Fikowski, founder and CEO of Changemark Research + Evaluation, brings 25+ years of lived and professional experience in substance use and mental health research. In this episode we cover her work on the SALOME trial, one of the rare studies that directly changed policy. But it wasn't just the science. It was how they centered participants from the beginning.

We also explore:

1. How to design community engagement and knowledge translation into your trial from day one
2. The gap between saying participants matter and actually building research around their humanity
3. What happens when you ask...

Clinical trials don’t become complex overnight, they get there one added process at a time.

In this episode, Ted and Liam break down why the industry is so effective at adding new layers, but rarely takes the time to remove what’s no longer needed. Whether it’s protocols, systems, or workflows, each addition is often made with good intent, but the cumulative effect can be significant.

They explore how this impacts sites in particular, increasing workload, creating friction, and ultimately making studies harder to execute. The discussion also highlights how relying on historical proces...

A 5 AM wake-up call. A perfectly planned setup. And a moment that never delivered.

In this episode, Liam and Ted use a story about a missed “blood moon” to explore a deeper truth in clinical trials: expectations don’t always match reality. They discuss how similar frustrations show up at clinical trial sites, where small issues stack up and slowly erode motivation.

They break down how friction at the site level, long trainings, broken systems, and unclear processes, gradually drains momentum. 

From pre-mortems to escalation paths, this conversation focuses on how to prepare for wha...

What does it actually mean to put the patient first?

In this episode, Liam and Ted explore the role of empathy and human connection in clinical trials. From rushed pre-screening calls to a powerful story of pausing a consent conversation just to connect, they highlight how small moments build lasting trust.

They also discuss why trust is rarely factored into budgets, despite being critical to recruitment, retention, and patient experience.

A thoughtful conversation on why clinical research needs to see the person behind the data.

What makes a truly high-performing team?
Inspired by the precision of Formula One pit crews, where the difference between winning and losing is measured in milliseconds, Ted and Liam explore what clinical trial teams can learn from elite performance environments.

Ted outlines six principles that drive high-performing teams: clear objectives, defined roles, mapped processes, and a culture of continuous improvement. Liam draws on his experience in professional sport to reflect on why teams that truly operate at that level are rarer than we think, and why clinical trials are no exception.

The episode leaves...

In Part 3 of 3, Liam and Ted continue their conversation with Frank Watanabe, CEO of Arcutis Biotherapeutics discussing work-life balance, building social capital, and management vs. leadership.

The conversation explores leadership at a practical level, from building trust across remote teams to creating flexibility that allows individuals to balance work and life in a way that works for them.

Finally, he outlines his vision for Arcutis and what “meaningful innovation” really means focusing on solving real problems that matter to patients and clinicians.

In Part 2 of 3, Liam and Ted continue their conversation with Frank Watanabe, CEO of Arcutis Biotherapeutics, focusing on what it takes to hire and build high-performing teams in high-risk environments.

Frank shares how he approaches hiring beyond technical skills placing strong emphasis on cultural fit, risk tolerance, and the ability to innovate. 
The discussion also explores how to create a culture where people feel comfortable taking risks and learning from failure. 

From encouraging teams to challenge the status quo to fostering psychological safety through leadership, Frank outlines what it takes to build organizations that co...

In this episode, Liam and Ted sit down with Frank Watanabe, President and CEO of Arcutis Biotherapeutics, to explore his journey from a Navy officer to a biotech executive and the leadership principles established along the way. 

Frank shares how his early experiences in the military and his transition into pharma and biotech influenced his approach to leadership, highlighting a key idea that defines his philosophy: leadership isn’t about authority, it’s about earning trust and loyalty.

They discuss how operating principles can become the “DNA” of a company, not just words on a wall, and...

A patient in a database is not a patient in a trial. So why do we keep treating feasibility like a headcount?

Fresh from a week deep in feasibility work, Liam introduces four characters who show up and cause chaos in almost every feasibility process. 

There's Spreadsheet Larry, who confuses a number with a truth. The EMR Oracle, who offers psychological safety dressed up as data. 

Prevalence Pete, who chases the sexiest percentage instead of the biggest addressable population. And Motivation Mabel, the patient who technically qualifies but simply isn't interested.

To...

In elite sports, races are often won or lost in the transition, and Liam and Ted argue that the same is true in clinical trials. Drawing on the precision of Olympic relay racing, they make the case that the handoff points between sponsors, CROs, and sites are where trials quietly succeed or silently fall apart.

From recruitment referrals that never get followed up, to sites given the green light before they're actually ready, the gaps are rarely dramatic, but the cost adds up. The culprit, more often than not, is assumption over communication.

Tune in...

Using a David Letterman-inspired “Top 10” format, the conversation highlights common feasibility pitfalls faced by sponsors, CROs, and clinical trial sites, including overly complex questionnaires, unrealistic enrollment expectations, delayed communication, and last-minute fire drills. 

The discussion goes beyond surface-level frustration to explore how sponsors and CROs can rethink clinical trial site feasibility by simplifying processes, questioning legacy requirements, and focusing on identifying and supporting sites with the highest potential for success. Ted and Liam also examine how better feasibility strategy can improve enrollment outcomes, reduce operational burden, and ultimately lead to more efficient clinical trials.

This episo...

Why do clinical trials struggle even when teams are experienced and well-intentioned?

In this episode, Liam and Ted explore why these outcomes are rarely about individual performance and far more often about system-level misalignments. They unpack how incentives, information flow, and decision rights across sponsors, CROs, and sites shape behaviour and why execution tends to break down logically, not randomly.

The discussion reframes “execution issues” as predictable outcomes of how trials are designed and governed, offering a clearer lens for understanding why good teams can still produce fragile results.

Eligibility criteria are meant to bring clarity to clinical trials, but in practice, they often do the opposite.

In this episode of Innovating Clinical Trials, Liam and Ted unpack how poorly worded, ambiguous, or misaligned eligibility criteria quietly slow enrollment, frustrate sites, and introduce risk later in development.

They explore:

- Why small wording choices create big downstream problems

- How “gray areas” force sites into interpretation rather than execution

- The disconnect between healthcare documentation and research expectations

- Why enrollment challenges often originate long before the...

In this episode, Liam and Ted unpack why enrollment behaves more like an operating system rather than a standalone process. They explore the question of ownership, the role sponsors play through protocol design, and how operational practices, healthcare realities, and human behavior all influence who ultimately makes it into a study.

The conversation moves through multiple lenses from eligibility criteria and healthcare documentation to behavioral science, site motivation, patient experience, and operational execution, highlighting why small decisions made early can have outsized effects later.

Tune in to explore why improving enrollment starts with rethinking how...

In this episode of Innovating Clinical Trials, Liam and Ted explore why building strong relationships with clinical trial sites requires more than dedicated relationship teams, it requires fixing problems at their source.

They discuss how many site challenges stem from outdated processes, one-sided agreements, and preventable operational friction that relationship teams are left to manage after the fact. Using real-world examples from confidentiality agreements to lab and portal issues, the conversation highlights the need for sponsors and CROs to look inward, modernize systems, and address root causes before sites feel the impact.

This episode is...

In this episode of Innovating Clinical Trials, Liam and Ted explore what determines the trajectory of a clinical trial and why success often depends on preparation, collaboration, and the ability to adapt when things don’t go as planned. They discuss how factors outside a site’s control, such as vendor selection and monitoring approaches, can significantly influence trial momentum.

Through real-world examples, the conversation highlights how thoughtful planning, supportive site interactions, and small human touches can have an impact on study performance.

Tune in to learn how anticipating challenges and strengthening collaboration can help keep...

In this episode of Innovating Clinical Trials, Liam and Ted challenge a familiar question in clinical research: “How do we increase enrollment?” Instead, they argue that progress starts by asking a better one- “What makes enrollment challenging in the first place?”

They explore how study design, existing therapies, operational factors, and most importantly, the lived experience of participants and their families all shape recruitment outcomes. Ted shares a practical framework for slowing down, asking deeper questions, and creating space for ideas that don’t emerge when teams jump straight to solutions.

Tune in to learn how refram...

In this episode of Innovating Clinical Trials, Liam and Ted explore why clinical research is, at its core, a people-driven business. Drawing on real-world experiences from both patient and site perspectives, they discuss how trust, communication, and human connection directly influence recruitment, retention, and study success.

From participant consent conversations to site selection and prioritization, the discussion highlights how “soft skills” often have a measurable impact on trial performance, yet are frequently overlooked in favor of technical experience alone. 

Liam and Ted reflect on how small moments of empathy, transparency, and genuine engagement can transform trans...

Welcome to Innovating Clinical Trials, the podcast designed for clinical research professionals eager to deepen their understanding of clinical trials through concise, insightful segments.

Join your hosts, Liam Eves and Ted Trafford, as they uncover the core issues in clinical research, reflect on the industry, and challenge conventional wisdom.

In this episode, Liam and Ted reveal how minor, unexpected requests often snowball into a significant site burden. They dive into why scope creep occurs, how sites can respond, and what sponsors can do to prevent it before it disrupts a study.

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Welcome to Innovating Clinical Trials, the podcast designed for clinical research professionals eager to deepen their understanding of clinical trials through concise, insightful segments.

Join your hosts, Liam Eves and Ted Trafford, as they uncover the core issues in clinical research, reflect on the industry, and challenge conventional wisdom.

In this episode, Liam and Ted explore what it truly means to be a sponsor of choice for clinical trial sites. They discuss how communication gaps between sponsors, CROs, and sites can slow progress, and hinder recruitment. They offer practical steps for improving communication in both...

Welcome to Innovating Clinical Trials, the podcast designed for clinical research professionals eager to deepen their understanding of clinical trials through concise, insightful segments.

Join your hosts, Liam Eves and Ted Trafford, as they uncover the core issues in clinical research, reflect on the industry, and challenge conventional wisdom.

Season 2 kicks off with Liam and Ted exploring what it means to be a “Sponsor of Choice.” Through thoughtful analogies and real-world insights. They explore why the “sweet spot” for feedback is just after a site enrolls its second or third participant when motivation, momentum, and study ex...

Welcome to Innovating Clinical Trials, the podcast where Liam and Ted explore the evolving landscape of clinical research and challenge the assumptions holding it back. In this episode, we sit down with Maya Zlatanova — CEO of TrialHub and FindMeCure, and host of Trials with Maya Z — for a no-nonsense look at one of the most misunderstood concepts in research: feasibility.

Episode Overview:

Maya takes us deep into the hidden layers of clinical trial feasibility, arguing that what most of the industry calls "feasibility" is really just site contracting in disguise. Instead, she introduces a broader, pati...