Note to File: A Clinical Research Podcast

Brad Hightower
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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. vor 23 Std.

    The Ugly Truth About Site Budgets, IWOs, and "Free" Trial Support with Daniel Fox

    Clinical trial sites are leaking money, often without even realizing it. In this episode of Note to File, Denali and Brad sit down with Dr. Daniel Fox of CRPN (Clinical Research Payment Network) to unpack the ugly truth about site finances, brutal IWOs, "free" trial coaches, and why so many sites end up doing work for zero pay. From unscheduled visits that never get reimbursed to vague CTAs that sponsors happily reinterpret after startup, Daniel breaks down exactly where sites lose money, how to protect yourself, and what real leverage you have, whether you're a small independent site or part of a growing network. The conversation also hits Operation Trialblazer, collapsing trial phases, PE/VC money in research, and how site strategy shifts when your endgame is an exit versus a long-term community mission. Stick around to the end for Daniel's surprise: a clinical research negotiating board game designed to help sponsors, CROs, and sites see each other's incentives and turn budget pain into something a little more fun. Episode highlights: - Why most sites treat finance like a side job and pay for it later   - IWOs, "invoice it or lose it," and contracts that quietly erase your revenue   - The gap between contract negotiators and coordinators doing the actual work   - How specific language in your CTA can save you from post-award "reinterpretation"   - IRB fees, pass-throughs, and central IRBs that don't want to pay sites   - Trial coaches and CTEs: "free" support that eats your time and margins   - Operation Trialblazer and what single, bigger trials mean for sites   - PE and big site networks: chasing EBITDA versus serving patients and sponsors   - When to fail fast on a bad trial instead of grinding it out and wasting money   - Daniel's CRPN negotiating board game and how it brings site finance to life If you run or support a clinical trial site and have ever asked, "Where did all the money go?" this episode is for you.

  2. vor 3 Tagen

    Anthony Corso on FDA, Trialblazer, and the Policy War Over Clinical Trials

    What happens when DC policy, FDA buzzwords, and real-world site pain all collide? In this episode, Brad and Denali sit down with Anthony Corso, VP of Public Policy at Veeva, to unpack the chaos and opportunity in today's "clinical research renaissance." We dig into:   - Real-time clinical trials and the mysterious rise (and fizzle?) of the FDA's Trialblazer initiative   - Why "real-time" safety data is mostly a fantasy at the site level   - One-and-done Phase 3 trials, master protocols, and how complexity keeps getting pushed onto sites and patients   - The quiet policy moves around fair market value, participant stipends, and how trial income can cost people their benefits   - ONC, EHRs, and the dream (or nightmare) of auto-matching patients to clinicaltrials.gov   - Why e-consent and e-source still aren't standard, and how misaligned incentives keep innovation stuck   - The real-world impact of trials: from oncology patients gaining years of life to the grind sites face just to keep the lights on   If you care about where clinical trials are actually headed – beyond the press releases – this one gets into the messy middle: policy, tech, regulators, CROs, sites, and the patients caught in the system. New here? Note to File is independent, unfiltered commentary for the clinical research community. Subscribe for more conversations on trials, tech, sites, and the people trying to fix this industry from the inside.

  3. vor 4 Tagen

    Why Sites Suck at Recruitment (And How To Fix It)

    From National Mac & Cheese Day to the broken economics of centralized recruitment… this Sticky Notes episode goes from nonsense to nuclear takes on how sites really handle patient recruitment. Denali and Brad dig into why so many sites are drowning in bad referrals, buried in tools, and still treating recruitment like a side quest instead of a core competency. They challenge the idea that sponsors and central vendors should own recruitment, and make the case that sites need to embrace what this really is: a sales process for motivated patients that can absolutely be done ethically. We get into:   – The reality of central campaigns, garbage referrals, and "anyone will click anything" ads   – Why sites complain about recruitment but won't invest dedicated people or time into it   – Site-owned tech vs sponsor tech sprawl (four logins just to pre-screen? really?)   – Personalized patient navigation: what it should actually look like at the site level   – How AI might help pre-screening… and where patients instantly check out   – The ethics of "selling" clinical trials without becoming a used car salesperson   – Why high-performing sites should get more of the recruitment budget and leads   Plus:   – A cash-pay surgery center in Oklahoma City that might be the perfect research partner   – Mac and cheese supremacy, Bastille Day, shark awareness, and why bugs are the enemy   – Why coordinators shouldn't be forced to moonlight as sales reps   If you run or work at a clinical research site, this one will either make you mad, motivated, or both.   Want more unfiltered conversations about clinical trial operations, sites, and industry nonsense?   Subscribe and check out notetofilepodcast.com for episodes, show notes, and more.

  4. vor 5 Tagen

    Inside the Clinical Research Site Collective: Why Sites Need a Real Advocate with Maria Ladd

    Clinical research sites are *quietly holding all the cards*—so why are they still struggling for support, fair budgets, and real partnership? In this episode of **Note to File**, Brad and Denali sit down with **Maria P. Ladd**, self-declared **Clinical Research Site Advocate** and co-founder of the **Clinical Research Site Collective**, to dig into the gap between sites, CROs, sponsors, and IRBs—and how we can finally start closing it. From **budget negotiations and profit margins** to **IRB relationships** and **site community-building**, this conversation hits the real, unfiltered pain points of running a research site in 2024 and beyond. --- In this episode, we get into: - Why Maria created the **Clinical Research Site Collective** and what "site advocacy" really means   - How sites can better **leverage IRBs** as a *resource*, not just a regulator   - The messy reality of **budget negotiations**, FMV, and why profit margin at sites should NOT be a dirty word   - How smaller and emerging sites can survive when studies keep getting more complex   - Whether we still need **local IRBs**—and what a "single IRB of record" world might look like   --- Who this is for: - Independent and emerging **clinical research sites**   - Site networks, AMCs, and research leaders   - CRAs, project managers, and sponsor/CRO folks who *actually* want to understand sites   - Anyone trying to build a more sustainable, collaborative clinical trial ecosystem   --- 🔗 **Connect with Maria**   LinkedIn: *Maria P. Ladd*   Clinical Research Site Collective: **clinicalresearchsitecollective.com** 🎧 More episodes & contact: **NoteToFilePodcast.com**

  5. vor 6 Tagen

    Diversity Mandates, Medicare Chaos, and Why Independent Sites Get the Hard Trials

    In this episode of **Note to File**, Brad and Denali dig into:   - **Why independent sites get boxed out** of imaging, colonoscopy suites, and other hospital-owned services   - How **legal, IRB, compliance, and procurement** teams quietly kill otherwise great trials   - The ugly reality of **Medicare coverage analysis**, double billing risk, and why millions go *unbilled* out of fear   - The latest political push around **diversity in clinical trials** (and why the new rhetoric doesn't quite add up)   - Whether decentralized trials and rural access actually solve the **diversity problem**—or just move it   - A new multi‑agent **AI "virtual trial design team"** (informaticist, clinician, statistician, etc.) that could finally fix our worst protocols   - Why **bad protocol design** is the real root cause behind "recruitment problems" and constant screen failures   Mixed in: national "holidays," accidental **snail farming**, and a July lineup of guests from site collectives, payments, and tech.   If you care about **independent sites**, **coverage analysis**, **DEI in trials**, and **where AI actually makes sense in clinical research**, this episode is for you.   🔔 **Subscribe** for more unfiltered conversations about clinical trial operations, site life, and the future of research.   🌐 More at **NoteToFilePodcast.com**

  6. 3. Aug.

    Operation "Trial" Blazer: Will It Actually Fix Clinical Research?

    World UFO Day, disco, and…Operation *Trial* blazer?   In this episode of **Note to File**, Brad and Denali kick things off with some classic nonsense—World UFO Day, Roswell, National Disco Day, and why U.S. soccer fandom magically appears every four years—before diving into a serious (and pretty spicy) breakdown of **clinical trial access, economics, and Operation Trailblazer**. We unpack:   - Why only **3–7% of oncology patients** ever make it into a trial—even though the majority say they *would* participate   - How **economic and household realities** (time off work, travel, childcare, insurance coverage) quietly gatekeep trial participation   - Why **oncology, IBD, chronic pain, and derm** behave very differently when it comes to trial incentives   - The tension between **protocol design vs. real-world feasibility** and whether we're making research harder than it needs to be   - What **Operation Trailblazer / "Trial Blazer"** actually is, who it's really built around (QRIs, AMCs, big systems), and what that means for **community sites and site networks**   - Whether government is fixing **paperwork problems or patient problems**   - EHR flags, master protocols, single pivotal trials, anti‑kickback safe harbors, and why **adoption** of existing guidance may matter more than any new initiative   - The weird mix of **American exceptionalism, global competition, and budget cuts** that shape U.S. research policy If you care about **site-level reality**, **patient access**, and how policy actually hits the ground (or doesn't), this one's for you. **Timestamps (approx):**   0:00 Cold open & intro   3:20 World UFO Day, aliens, and deep-sea vs deep-space   7:40 Made in the USA Day, World Cup, and U.S. soccer culture   10:15 National Disco Day & Note to File playlist ideas   11:55 Why so few oncology patients join clinical trials   16:30 Insurance, community cancer centers, and structural barriers   19:40 Are we making trials hard on purpose—or just badly?   20:50 Operation Trailblazer / "Trial Blazer" overview   23:10 Qualified Research Institutions (QRIs) & phase I focus   24:45 Could community sites do this better than AMCs?   27:00 EHR flags and why doctors mostly click past them   29:45 Participant payments, undue influence, and safe harbor   31:30 Single pivotal trials & what that means for sites   33:30 Master protocols & not reinventing the wheel   36:00 Policy, trust, and guidance no one follows   39:00 Fourth of July disco playlist & outro **Listen if you're into:**   - Clinical trial operations & site strategy   - Oncology and access to innovation   - U.S. research policy & Operation Trailblazer   - Real talk about what actually works at the site level

  7. 2. Aug.

    Capitalism, China & Clinical Trials: Follow the Spreadsheet

    Is "innovation" in clinical trials just a cover for offshoring risk and cozy politics?   In this episode of **Note to File**, Brad and Denali dive into two big stories shaping clinical research right now:   1. **Congress vs Big Pharma in China**      - US House subcommittee letters to Merck, AbbVie, Lilly, Pfizer & more      - Early-phase trials in **Chinese military hospitals**      - Alleged **informed consent gaps** and **IP leakage** to the Chinese military      - Is this about **ethics & patient safety**, or **America-first politics** and control?   2. **"Real-Time Trials" & the Paradigm Problem**      - What the hell is *"signal-level data"* actually supposed to mean?      - Why the FDA + Paradigm announcement felt like **ready, fire, aim**      - Venture capital, ex-government leadership, Operation Warp Speed ties      - Are we solving real problems, or just funding the best press releases?   Along the way we also hit:   - Work-life balance vs American grind culture (paternity leave, 4‑day work week)   - National "holidays" for everything (Asteroid Day, Social Media Day… Note to File Day when?)   - Clinical trials in **Minecraft** (yes, we went there)   If you care about **where trials are really going**—who controls the data, who sets the rules, and who actually benefits—this one's for you.   👉 **Subscribe** for more unfiltered, independent commentary on clinical trials, sites, and the messy reality behind the headlines.   💬 Got thoughts on China trials or real-time trials? Drop them in the comments or hit us at **NoteToFilePodcast.com**.

  8. 1. Aug.

    Small Sites, Big Tech, and the AI Hype Train in Clinical Trials

    Are we actually innovating in clinical research… or just slapping AI buzzwords on old problems? In this episode of Note to File, we go deep on: Founder-led vs board-appointed CEOs – why "benevolent dictators" might actually get more done Why eccentric weirdos sometimes make the best leaders (and the worst coworkers) The wave of AI-in-clinical-research announcements (Florence, EISF, "chat with your data," etc.) and why so much of it is just… AI slop What sites REALLY need from AI: Auto-filing ISF docs Building source from protocols Actual agentic labor, not just another chat box CTMS vs QuickBooks – why finances at research sites are still a mess The tension between running a research site like a business vs. not selling your soul to PE-backed growth-at-all-costs The rise of small, independent sites and what's actually working for them Along the way we detour through National Fudge Day, World Sea Turtle Day, and whether loving vegetables is a valid qualification for being CEO. If you're a site owner, coordinator, sponsor, CRO, or tech vendor who's tired of hype and wants unfiltered, practical talk about the future of sites + AI, this one's for you. 👉 Subscribe for more independent, no-BS conversations about clinical research. 📬 Got a topic or rant? Hit us up at NoteToFilePodcast.com

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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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