『Note to File: A Clinical Research Podcast』のカバーアート

Note to File: A Clinical Research Podcast

Note to File: A Clinical Research Podcast

著者: Brad Hightower
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【Amazonプライム会員限定】今ならプレミアムプランが4か月 月額99円。

10月19日まで。※適用条件あり
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. マネジメント マネジメント・リーダーシップ 経済学 衛生・健康的な生活 身体的病い・疾患
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  • Wearables, Wagers, and White House Hype
    2026/08/11

    Note to File gets extra spicy on this one. Brad and Denali riff on everything from wearables and brain health studies to the White House's new "Science: A New Golden Age" report and why U.S. clinical trials are still so painfully slow, expensive, and overburdened.

    They dig into:
    - Why consumer wearables like Oura and Whoop still aren't meaningfully integrated into most trials
    - The gap between "we're in a new golden age of science" headlines and the on-the-ground reality at research sites
    - The ethics and impact (or lack thereof) of sports-style betting on clinical trial outcomes via platforms like Kalshi
    - The industry's obsession with collecting more data "just because," and how that plays out in bloated screening visits
    - Brad's very real decision to move his site's source back to paper and what that says about the current state of eSource

    If you care about site operations, U.S. trial competitiveness, the future of AI and wearables in research, or you're just here for the unfiltered clinical trials commentary and nonsense, this one's for you.

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    31 分
  • The Ugly Truth About Site Budgets, IWOs, and "Free" Trial Support with Daniel Fox
    2026/08/10

    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.

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    54 分
  • Anthony Corso on FDA, Trialblazer, and the Policy War Over Clinical Trials
    2026/08/07

    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.

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    1 時間 1 分
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