Note to File: A Clinical Research Podcast

Brad Hightower
  • 4.9 (29)
  • Management
  • Updated Biweekly

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. 14h ago

    Clinical Trials or Casino? FDA Bets, Seeding Trials & Site Survival

    In this Sticky Notes episode, we riff on everything from clinical trial prediction markets (yes, literally betting on FDA approvals) to the murky world of seeding trials that look a lot more like marketing campaigns than science. We dig into: End Point Arena & trial prediction markets – paper trading today, real money tomorrow? How investors already "bet" on trial outcomes by mining clinical data for stock picks Seeding trials in phase 3/4: when "research" is really about drug exposure & provider behavior The thin ethical line: are patients being misled when trials are primarily commercial tools? IRB transparency (or lack thereof): what actually gets rejected, and who decides? The blurry crossover between R&D and commercial, from branding during trials to MSLs as quasi-sales Why most sites secretly need a sales & marketing mindset just to keep the doors open Along the way, we also hit: Conference season chaos National Cheese Day, Hug Your Cat Day, and Moonshine Day The ever-expanding definition of a "study coordinator" If you're in sites, sponsors, CROs, or pharma and you've ever wondered, "Where does science end and sales begin?"—this one's for you. 👉 Have a topic you want us to tear apart next? Drop it at NoteToFilePodcast.com

  2. 1d ago

    Why EU Sites Feel Different: Workweeks, National Health Systems & Real-World Data

    Ever wondered what's REALLY happening with your pharmacy data, how EU sites operate compared to the U.S., or whether you actually need $1.5M to start a research site? In this episode of Note to File, Brad and Denali go full sticky-note mode, bouncing from European work culture to GDPR smackdowns to the future of real‑world data and AI in clinical research. In this episode, we dig into: Copenhagen recap & EU site culture Denali's trip to the Veeva R&D & Quality EU Summit in Copenhagen Why EU sites feel more integrated with sponsors and health systems The dominance of hospital- and health system–based sites vs. U.S. independents Why true independent sites are rarer in Europe (overhead, infrastructure, and system design) Four-day workweeks, efficiency & "wage slavery" European 36-hour workweek norms in healthcare Do four-day weeks actually maintain productivity? Brad's reality check: embedded in clinics seeing patients 5 days a week Efficiency vs. butts-in-seats: "Do great work, then go live your life." IQVIA's GDPR fine & the illusion of anonymized data Breakdown of the €5M GDPR fine tied to French health data warehouses Pharmacy and EMR data used for real-world evidence and analytics Why "anonymized" often… isn't Lack of transparency, consent, and real opt-outs for patients How this parallels U.S. pharmacy data being used for recruitment and targeting Consent, terms of use & contract fatigue Are we really "consenting" when we click through IRB portals, pharmacy forms, and app updates? Contract fatigue in modern life: signing everything, reading nothing Data breaches, token identity monitoring, and what your data is apparently "worth" Site startup myths & market trends The myth that you need $1.5M to open a site vs. Brad's "a few thousand and some hustle" Summer slowdown vs. pickup in site activity, PSVs, and study awards How the current U.S. administration and policy uncertainty ripple through the pipeline Real-world data, AI, IPOs, and whether anyone actually knows what they're building All of this wrapped in the usual unfiltered, slightly chaotic, no-agenda Note to File energy—with shoutouts, side quests, and a friendly "podcast war" declaration with Steve Wimmer's new show.

  3. 2d ago

    Can We Standardize Clinical Trial Data Like Air Traffic Control?

    In this episode of Note to File, Brad catches up with Denali live from Copenhagen as she kicks off the Veeva EU Summit—their first year meaningfully bringing sites into the mix. They dig into: -How the EU site landscape really compares to the US -Whether sites and sponsors are actually more collaborative in Europe -Why M&A and site networks look different across the pond -And the big one: what airline interoperability and air traffic control can teach clinical research about standards, data exchange, and real-time oversight Denali walks through her travel saga—from Delta to SAS to FlightAware—as a perfect analogy for how clinical trial tech breaks down the moment systems stop "speaking the same language." Brad and Denali explore why we still don't have: -A "TSA / air traffic control" equivalent for clinical trials -Minimal, shared standards for how data moves between sites, sponsors, and vendors -Real incentives to play the long game ("one marshmallow now vs. five later") on interoperability They also touch on: -GDPR and EU data laws vs. US incentives -What "meaningful use" did for healthcare data—and whether trials need their own version -Why standardizing how data is transmitted (not the IP itself) could finally unlock speed and efficiency for everyone And, of course, it wouldn't be Note to File without a little nonsense: -Opening a Lisbon site -Traveling as an American right now -And the pitch for Steve Wimmer's fractional marshmallow MLM If you care about site–sponsor relationships, global site networks, or why clinical trials still can't talk to each other in 2026, this one's for you.

  4. 5d ago

    Skinny Migraine Patients Only? The Ethics of 'Unicorn' Trial Design

    Clinical trials are supposed to be science… but are they really? In this episode of Note to File, Denali and Brad riff on everything from Veeva's EU R&D Summit in Denmark to patient recruitment reality vs. industry fantasy, and end up in a pretty honest place: We're designing protocols for patients who don't exist. We dig into: -Veeva EU R&D Summit & "site day zero" -Site–sponsor collaboration in the EU -The chaos of regulations, cultures, and data sovereignty across a whole continent -AI, agents, and site efficiency -Auto‑filing IRB approvals into the ISF/TMF -Schedule builders from the protocol -eSource–EDC connectivity so sites never log into EDC again (in theory…) -Patient recruitment reality -Why mining clinic EHRs can feel creepy and low‑yield -Advertising vs. "trusted doctor referral" -Why Facebook ads can deliver more motivated patients than the clinic database -The unicorn protocol problem -Writing inclusion/exclusion for "perfect" patients just to get a clean signal -Migraine studies where BMI cutoffs exclude the real‑world population -Ethical questions: are we testing drugs on the people who will actually use them? -Are clinical trials even good science? -Lack of reproducibility across sites -Wild variation in source docs and workflows -The tension between "clean science" and messy real‑world practice Along the way we also hit: -Clinical Trials Day and the tidal wave of self‑congratulatory LinkedIn posts -Why Brad is warming up to advertising despite his embedded‑site roots -How site economics punish all the pre‑screening that doesn't enroll -Motivations for participation: altruism, access to care, and "I just trust my doctor" If you care about site operations, protocol design, and whether we're actually doing good science, this one's for you.

  5. 6d ago

    Joe O'Rourke: Private Equity, Retail Pharmacies & The Future of Research Sites

    The retail pharmacy revolution in clinical trials didn't exactly go as advertised. So what actually happened inside Walgreens, and what does it mean for sites? In this episode of Note to File, Brad and Denali sit down with Joe O'Rourke to unpack the real story behind retail pharmacies in clinical research – what worked, what didn't, and why traditional sites are still carrying most of the load. We get into: -Joe's origin story – from metabolic research at Johns Hopkins to pharma services and sales -How he built an early digital recruitment engine that spent $2M on Facebook in 50 days -Why Walgreens entered (and stuck with) clinical trials despite brutal rumors and headlines -The BARDA head‑to‑head trial: Walgreens vs a traditional CRO on speed, quality, and scale -Where retail pharmacies actually make sense in clinical trials (and where they absolutely don't) -How private equity, giant P&Ls, and misaligned incentives shape whether these models survive The universal pain for research sites: -Slow study startup -3% overhead fights that drag for 4 months -Opaque feasibility and "prove you're a real site" bias -Why even big AMCs are losing money on research and leaving 7‑figures unbilled -The role of novel sites, standardization, and site networks in fixing startup and sustainability -A teaser for Part 2: Brad's "cornucopia" of IRB questions for Joe and WCG If you're running a site, working at a sponsor or CRO, or trying to figure out whether retail pharmacies are friend or foe, this episode will feel uncomfortably familiar.

  6. Jul 22

    WHO's New GCP Course, China Data Ban & FDA's AI Pilot

    National Tourism Day, a mystery virus on a cruise ship, WHO launches a free clinical trials course, Congress wants to ban China data, and FDA is piloting AI-enabled early phase trials. Light vibes, heavy implications. In this episode, Brad and Denali riff on how all of this actually hits sites, sponsors, and patients: In this episode we cover: WHO's new free, self-paced clinical trials course 4.5 hours, 9 themes (ethics, GCP, community engagement, operational feasibility, etc.) Is this just another GCP box-check… or something more practical for real-world sites? Pandemic preparedness & the latest cruise ship outbreak Person-to-person transmission, high fatality, and what this says about "the age of pandemics" How global standards and infrastructure (WHO, Warp Speed, etc.) either help… or fall apart House panel move to ban clinical data from China, Russia, Iran, North Korea Concerns about IP theft, ethics, and data quality vs. the real motive: geopolitics and money What happens to diversity, inclusion, and global enrollment if we shut out huge populations? FDA's push to speed R&D & the AI-enabled early phase trials pilot Mirroring Australia's clinical notification model Public comments on the AI pilot: signal vs. noise, and who's just selling their product Paradigm's role, direct-to-FDA data streaming, and whether oncology is the worst place to start Sites, CROs, and sponsors caught in the middle Are we actually making trials faster and more efficient, or just reshuffling paperwork? Why free, credible training matters for developing countries and new site staff If you care about site operations, GCP that actually means something, global data politics, AI in clinical trials, and how any of this reaches coordinators and patients, this one's for you.

  7. Jul 21

    Over 50% of Sites Are STILL on Paper?!

    Are we seriously still building source from scratch in 2025? In this episode of Note to File, Denali and Brad break down a new Tufts / CRIO paper on how sites actually prepare source and CRFs—and what the data really says about "innovation" in clinical trials. We get into the uncomfortable truth: -54% of sites are still using paper for visit source -Only 16% are using EMR/EHR to capture research data -Sponsors talk about real-time clinical trials, interoperability, AI, while sites are still living in Word docs, PDFs, and binders In this episode, we cover: -Why sites are forced to DIY source from protocol + CRF guidelines -The 6‑week lag to get critical docs from sponsors -How siloed CRO / sponsor teams make everything worse -Paper vs eSource: where electronic actually helps—and where it doesn't -Why "site-centric tech" is often just site-owned tech, not site-valuable tech -Where CTMS, finance, and eReg really do move the needle for sites -What has to change for sponsors and sites to both win If you run or work at a site, this is a reality check on where tech actually helps—and where paper is still winning by default.

  8. Jul 20

    Real-Time Clinical Trials: FDA's Big Bet or Big Mess?

    The FDA just announced a bold push for real‑time clinical trials (RTCT) — including proof‑of‑concept studies, a new pilot program, and an RFI on AI-enabled tech to speed up decision‑making. But from the site and operations side, does any of this actually solve the real problems? In this Note to File episode, Denali and Brad dig into: What the FDA actually said in the recent RTCT press conference -The claim of "45% dead time" in trials – and what's really happening between last patient visit and submission -Why data streaming to FDA in real time raises huge questions about -Unclean / unadjudicated data -Unblinding risks -Sponsor exposure and control -How vendors like Paradigm and eSource / EHR data streams are being positioned as the tech backbone -Whether AI + interoperability can actually reduce timelines vs. just create new buzzwords -The disconnect between patient recruitment as the true bottleneck and this focus on data plumbing -Local vs. central IRBs, FDA commentary on IRB "modernization," and what that means for communities and oversight -Why so many people are clapping on LinkedIn while the details remain incredibly vague This is a skeptical but fair breakdown from the site-level trenches: What could RTCT get right? Where is it wildly underbaked? And what should sites, sponsors, and vendors be watching closely as the RFI window closes and the pilot program takes shape?

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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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