Note to File: A Clinical Research Podcast

Brad Hightower
  • 4.9 (29)
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Note to File is a podcast for clinical research sites - interviews, best practices, and candid commentary from Brad Hightower, founder of Hightower Clinical and clinical research professional.

  1. 2D AGO

    Trial Naming Ethics, Branding vs. Recruitment, and the Site Staffing Squeeze

    Today on  Note to File, we riff on everything from **Air Max Day** to the very real challenges facing clinical trial sites in 2026. We start light with sneaker talk and "national days," then dive into three meaty topics for the clinical research community: 1. **The Ethics & Psychology of Trial Acronyms**      - Are names like **HERCULES**, **IRONMAN**, or **CINDERELLA** harmless branding or subtle false promises?      - How mythological or aspirational names can shape **patient expectations**, hope, and decision‑making.      - Why ultra-generic names like "SUMMIT" or cryptic codes like *D6‑75309‑0001* both cause headaches for sites, sponsors, and indexing. 2. **Branding Clinical Trials vs. Actually Recruiting Patients**      - The difference between **drug branding** (post‑market) and **trial advertising** (short‑lived, action‑oriented).      - Why patients don't care about the "Cinderella Trial" – they care about **their pain, their disease, and their options**.      - How segmenting your audience and tailoring creative (rather than forcing one unified "brand") can drive better recruitment and diversity.      - Real‑world example: why ads showing **real pain and limitation** outperformed "happy, active" imagery for phantom limb pain trials. 3. **Site Staffing: Slightly Better, Still Rough**      - Why site org charts are usually **flat**, with limited traditional "career ladder" for coordinators.      - The ongoing tension between **sites vs. CRO/CRA roles**: more money and prestige vs. travel, burnout, and less flexibility.      - How **culture, flexibility, learning opportunities, and fair pay** can keep great staff at sites.      - Ideas for giving coordinators **growth without fake titles**: exposure to budgets, BD, regulatory, data, and operations. Along the way, we talk about:   - Equal Pay Day and how **structural disparities** show up in research careers   - The impact of **remote monitoring** on CRA life   - Why "butts in seats 8–5" is a terrible proxy for productivity   - How sites can lean into their strengths to become **great places to build a career**, not just a stepping stone If you're a **site owner, coordinator, CRA, sponsor, or vendor** trying to navigate recruitment, staffing, and branding in real life (not in pitch decks), this one's for you.  **Subscribe** for more candid, unfiltered conversations about the clinical research industry, and check out more at **notetofilepodcast.com**.

    32 min

  2. 2D AGO

    Clinical Trials, Creepy Data, and Corporate B******t

    It's March 24th and we're back with another **Sticky Notes** edition of **Note to File: A Clinical Research Podcast**—where we mix serious industry topics with just the right amount of nonsense. In this episode, we cover: - 🥩 **National Cheesesteak Day** (plus cocktails, "National Stephanie Day," and the strangely titled *International Day for the Right to the Truth…*)   - 💊 **National Adverse Drug Event Awareness Day** – why women are disproportionately affected, and how trial design and dosing play a role   - 🧩 **ICON + Advarra's "research-ready, connected site network"** – is this actually helping sites, or just more sponsor/CRO-controlled tech dumped on them?   - 📊 **Who owns your site data?** We dig into how IRBs and vendors may be using operational data for site selection and "intelligence"   - 🧪 **Dana-Farber's $15M NIH settlement** over manipulated images – what this says about accountability in academic research   - 💼 **New study on "corporate b******t"** – why people who see through buzzwords and jargon may actually be *better* at their jobs (and why Kool-Aid drinkers might be happier) If you work at a site, sponsor, CRO, IRB, or anywhere in the clinical trial ecosystem—and you're tired of sanitized, corporate-approved narratives—this one's for you. --- ### 🔖 Suggested Timestamps 0:00 – Cold open   2:13 – Welcome to Note to File   2:41 – Spring, spring break, and weather nonsense   4:09 – National Cheesesteak Day & the "day of the day" rundown   6:29 – National Adverse Drug Event Awareness Day (and gender differences)   9:12 – ICON + Advarra "research-ready" network – what does this really mean for sites?   12:06 – Are vendors mining site data for sponsors? Data ownership & ethics   17:52 – Dana-Farber $15M NIH settlement over manipulated data   22:02 – Study: corporate b******t, buzzwords, and job performance   25:10 – Kool-Aid, happiness, and critical thinking at work   26:31 – Wrap-up --- **About Note to File**   Note to File is a clinical research podcast featuring interviews, candid commentary, and general nonsense for the clinical research community. No corporate spin, no paid messaging—just real talk from people in the trenches. 🌐 More at: **notetofilepodcast.com**   --- #ClinicalResearch #ClinicalTrials #ResearchSites #Advarra #ICON #NIH #DanaFarber #Pharma #CRAlife #NoteToFile #HealthcareData #WorkCulture

    25 min

  3. 5D AGO

    Will Gen Z Fix What's Broken in Clinical Trials?

    Ever feel like life – and clinical research – are both a little chaotic and unpredictable… kind of like March weather and tornado season in Oklahoma? In this **Sticky Notes** episode of **Note to File**, Brad and Denali kick things off with some real-life banter:   - Spring break in **Oklahoma City**   - Unseasonably **90-degree** days   - The joy and dread of **tornado-adjacent season**   - How March and April always seem like a weather "crap shoot"   From there, we pivot back into the spirit of Note to File: candid, unscripted conversation for the **clinical research community**. If you're a CRC, coordinator, site owner, CRA, or just clinical-research-curious, this is your space to hang out, unwind, and still feel connected to the work. 🔹 **What you can expect from Sticky Notes episodes:** - Short, informal check-ins between full episodes   - Real talk about life *around* clinical research   - The same unfiltered, practical vibe you know from Note to File   --- 📌 **About Note to File**   **Note to File** is a clinical research podcast featuring interviews, commentary, and plenty of unscripted nonsense for people who live and work in the world of trials. 👉 More episodes, resources, and info:   [https://notetofilepodcast.com](https://notetofilepodcast.com) --- 👍 If you enjoy this episode: - **Like** the video to support the channel   - **Subscribe** for more clinical research conversations   - **Comment** where you're listening from and what your weather's like today #ClinicalResearch #NoteToFile #StickyNotes #ClinicalTrials #ResearchSites #CRCs

    31 min

  4. 5D AGO

    Why Women Still Don't Show Up in Clinical Trials (And What Marketing Gets Wrong)

    Are we turning "clinically proven" into just another marketing buzzword? In this Sticky Notes live episode, Denali and Brad dive into how the public encounters *clinical trials* not through journals or regulators, but through mushroom coffee emails, peptide ads, and GLP‑1 hype on social media. From biohacking with gray‑market peptides to the underrepresentation of women in research, this conversation pulls back the curtain on how science, perception, and marketing collide. 🧪 **In this episode we cover:** - **National Doctor–Patient Trust Day & St. Patrick's Day:**     Lighthearted banter about trust in medicine, drunk crowds, and corned beef vs. Taco Tuesday. - **Mushroom Coffee & "Clinically Proven" Marketing:**     An 8‑week "randomized clinical study" in a marketing email: what does that really mean?     Who's running these trials, where's the FDA, and how much should we trust claims like "clinically tested"? - **Vitamin B12, GLP‑1s, and Safety Trade‑offs:**     Emerging concerns about impurities and interactions in GLP‑1 compounding.     How fast is *too* fast when it comes to development, approval, and post‑market surprises? - **Peptides, Biohacking & the Gray Market:**     Ordering research‑grade peptides and GLP‑1 analogs straight from overseas.     N=1 "self‑experiments," influencer before/after pics, and where personal autonomy meets real safety risk. - **Why Women Are Underrepresented in Trials:**     A study showing women are 51% of the population but only ~41% of trial participants.     Logistics, fear, eligibility criteria, and how trial design and history stack the deck.     Would men give the same reasons for *not* joining a trial? 🎧 **Who this episode is for:** - Clinical research professionals who want an honest, unfiltered take on how the public actually sees trials   - Sponsors, sites, and CROs thinking about trust, recruitment, and representation   - Anyone tempted by "clinically proven" supplements, peptides, or weight‑loss injections   - Curious listeners who like candid, sometimes irreverent conversations about medicine and research --- 🔔 **Subscribe** to Note to File for more independent, unfiltered conversations about the clinical trial industry.   💬 Have a topic you'd like us to tackle next? Drop it in the comments or reach out at **notetofilepodcast.com**.

    30 min

  5. MAR 4

    Tarantulas, Raccoons & $3.5B Drug Plants

    From raccoons with thumbs to $3.5B drug factories, this Sticky Note goes from absurd to deadly serious pretty fast. In this episode, we dig into three big themes shaping the future of clinical research: 1. Lilly's $3.5B U.S. Manufacturing Bet New mega‑facility in Pennsylvania and three more planned in the U.S. How policy, tariffs, and incentives are pulling drug manufacturing back onshore What this means for historically industrial regions that lost manufacturing jobs 2. China's Clinical Trial Explosion China now accounts for ~30% of global clinical trials Trials reported as 50–60% cheaper and 60–70% faster than in the U.S. Regulatory shifts, trial infrastructure, and why the U.S. may get left behind on the "science" side while focusing on manufacturing 3. The Hard Reality of Community Oncology Research Why oncology trials in community settings are so hard to run Inclusion/exclusion challenges, timing of care, and tiny eligible populations Financial reality for IROs/site networks vs. the clear ethical need for community oncology trials Plus: Burnout in clinical research and why it's under‑recognized at the site level SOS Conference in San Diego, what to expect, and why the vibe matters A brief detour into exotic pets, tarantulas, and weaponized raccoons (you've been warned) If you care about where trials get run, who gets access, and how policy quietly reshapes our entire ecosystem, this one's for you.

    36 min

  6. MAR 2

    Nobody Knows What Clinical Research Is

    In this episode of Sticky Notes, Brad and Denali debrief from the VIVE conference in LA, where they discovered just how little most health systems, CIOs, and IT vendors really understand about clinical research. From translating basic terms like CTMS and CRC into plain language, to explaining why research even matters to hospitals and health plans, we dig into the massive awareness gap between care delivery and clinical trials. We also get into: -Why research divisions inside hospitals are often ignored or siloed -How vendor messaging has to completely change when talking to health systems -The rise of real-world data (RWD), claims data, and EHR data in regulatory decisions -New FDA guidance on Bayesian statistics and using historical data -The shift toward one pivotal trial and what that could mean for sites, CROs, and sponsors -Whether we're trying everything except just running better randomized clinical trials -How conference culture is changing – from hard-sell BD apps to real community (looking at you, Save Our Sites) Plus, in true Sticky Notes fashion, there's some talk about National Pistachio Day, renting guitars to shred at conferences, and why pistachios look weird but still slap.

    29 min

  7. MAR 2

    Investigator-Initiated Trials in Eye Care with Dr Brad Hall

    In this episode of Note to File, Denali and Brad sit down with Dr. Brad Hall, founder of Senge, a boutique CRO focused on investigator-initiated trials (IITs) in eye care. They break down how independent clinicians can turn real-world questions from daily practice into publishable clinical research. In this conversation, we cover: -Why most IITs in eye care actually happen in private practice, not academia -The biggest barriers independent clinics face (time, staff, IRB, budget) -How to start with retrospective studies and build toward prospective IITs -Funding options and how to partner with industry for real-world data -Practical pros and cons of paper vs. EDC for small IITs -Dr. Hall's LENS system from his book Idea to Impact: -Launch with focus – defining the question, protocol, and consent -Enroll with confidence – recruiting and retaining patients -Notice the insights – collecting clean data and analyzing it -Share the results – publishing and presenting your work If you're an eye care provider (or any specialist) who's ever thought, "I see this pattern in my patients—could I turn this into a study?" this episode will show you what it actually takes to go from idea to impact.

    43 min

  8. MAR 2

    ICON's Collapse, CRO Credibility, and FDA Oversight

    -Are CROs "necessary evil" partners or overhyped money machines — and what does ICON's 50% stock plunge really tell us about the state of clinical research? In this Sticky Notes episode of Note to File, we riff on everything from conferences and culture to credibility and regulation in our industry, including: -ICON's revenue overstatement and the brutal market reaction -What a 2% revenue error really means for trust, transparency, and CRO credibility -The strange love/hate dynamic around CROs on LinkedIn, Reddit, and in the trenches -How health system execs still don't really "get" research — and why that matters -The massive gap between research professionals and healthcare executives at conferences like VIVE and Scope -Whether the FDA could streamline oversight for low-risk trials without new legislation -Why risk-based monitoring and "common sense" regulation still haven't truly shown up at the site level -The paradox of an industry that bets billions on long-shot drugs but is terrified of operational innovation -Sponsors as the real power center: why nothing changes until sponsors want it to If you're a site, sponsor, CRO, or just a research nerd trying to make sense of where this industry is headed, this one's for you.

    32 min
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4.9
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Note to File is a podcast for clinical research sites - interviews, best practices, and candid commentary from Brad Hightower, founder of Hightower Clinical and clinical research professional.

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