The Scope of Things

In this episode of the Scope of Things, host Deborah Borfitz shares the latest news on a drug repurposing AI model now being tested in rare disease clinical trials, a new way forward for triple-negative breast cancer, Jill Pellegrino’s transition from CVS to AutoCruitment, incorporating placental pathology into perspective clinical trials, making ethical oversight of clinical trials more “fit-for-purpose,” and publication bias with industry sponsored studies for psychiatric drugs. We also have Allison Proffitt, editorial director of Clinical Research News, interviewing speakers at SCOPE Europe 2024 on how AI is being used for clinical trials, their pick for the 2024 rising star in the clinical research ecosystem, and the most hotly-debated topics in trial planning and execution. SHOW NOTES News Roundup AI for drug repurposing Study in Nature Medicine Window trial for new breast cancer approach Study in Science Advances Article in Bio-IT World  Prescreening regimen of AutoCruitment Article in Clinical Research News Episode 12 guest appearance on podcast  Trials needing placental pathology Opinion piece in Trends in Molecular Medicine Fit-for-purpose ethical oversight Special communication in JAMA  “Sponsorship effect” on psychiatric drug trials Study in Journal of Political Economy   Guests  Nicole Stansbury, Head of Global Clinical Operations at Premier Research Farrell Healion, Head of Emerging Technologies at AstraZeneca Jonathan Crowther, Head of Predictive Analytics, PRD (OARS), Pfizer  The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.

Tune in for the latest news and trends in this month’s episode of the Scope of Things, where host Deborah Borfitz covers everything you need to know about a pending launch of a large treatment trial for Graves’ disease, a recruitment campaign for a diagnostic tampon, Walgreens and BARDA’s new partnership, how eligibility criteria has been excluding people of African or Middle Eastern descent from cancer studies, and more. Joining the discussion is Aaron Mackey, vice president of AI and data science at Lokavant, who talks about the unintended consequences of decisions made during trial planning that can lead to questionable conclusions, how AI and ML are helping with the diversity issue in trial participation, and his stop gap emergency plan to keep trials on track if there is no digital support available. SHOW NOTES News Roundup Phase 3 trial for Graves’ disease Article in Clinical Research News  Quality of life measures in cancer studies Study in Journal of Clinical Oncology Article in Clinical Research News Rapid recruitment for a diagnostic tampon trial Article in Clinical Research News Reference trial emulation Study in PLOS Medicine  Walgreens/BARDA partnership News brief in Clinical Research News “Detective” algorithm for improving trial design Study in Nature Genetics Exclusion of people with Duffy-null phenotype Study in JAMA Network Open    The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.

This month’s episode of The Scope of Things features the latest trending news from host Deborah Borfitz, including a planned library of “nature’s drugs” targeting complex diseases, a paradoxical approach to treating cancer, how government policies can help improve equitable access to cancer trials, and the possibilities of reversing multiple sclerosis nerve damage. Marshall Summar, CEO of Uncommon Cures, and Tamanna Roshan Lal, Chief Medical Officer of Uncommon Cures, join the conversation to discuss how their organization is tackling the root causes of rare diseases trials that take too long and cost too much. They delve into the market interest behind rare disease trials and what Uncommon Cures is doing differently, as well as share the company’s international expansion plans and where they see this operationalized rare disease clinical trial paradigm in a few years. SHOW NOTES News Roundup Pharmaceutical-grade HMOs Article in Clinical Research News Paradoxical cancer treatment approach Study in Cancer Discovery  Article in Clinical Research News   Switching on the desire the exercise Study in Science Advances STEP stroke platform trial Press release from the University of Cincinnati Policy interventions to improve trial equity  Study in Journal of Clinical Oncology Article in Clinical Research News New drug for MS Study in PNAS Guests CEO Marshall Summar, M.D., and CMO Tamanna Roshan Lal, M.D., with Uncommon Cures  Article in Clinical Research News The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.

Tune into this month’s episode of the Scope of Things, where host Deborah Borfitz covers the use of AI for trial screening and recruitment purposes, a diabetes drug that may help treat sleep apnea, questionable advice from the FDA given to departing staffers, why the entire clinical trial enterprise may need to be revamped to eliminate systemic biases, and more. Hannah Kemp, vice president of strategic client engagement at Surgo Health, also joins the conversation to talk about how Surgo Health is helping companies recruit participants and her SCOPE 2024 presentation, as well as her thoughts on patient-focused drug design and the challenge of getting study sponsors on-board with enrollment strategies. SHOW NOTES News Roundup AI for clinical trial screening  Study in NEJM AI AI for trial recruitment  Study in Ophthalmology Science  Drug therapy for sleep apnea Study in NEJM    Investigation on departing FDA employees Article in The BMJ  N-Power Medicine/Merck collaboration Press release Youth prediabetes/diabetes dataset Link to POND web portal Systemic biases in randomized controlled trials Study in Journal of Ethnicity in Substance Abuse  GUEST BIO Hannah Kemp, vice president of strategic client engagement, Surgo Health Hannah Kemp is the Vice President of Strategic Client Engagement at Surgo Health.  In her role, she helps clients develop more patient-centric healthcare and clinical trials leveraging Surgo’s novel data. Ms. Kemp has led large-scale projects across multiple therapeutic areas from infectious disease, maternal health, vaccines, and cancer and published. Ms. Kemp brings an ecosystem perspective having worked across healthcare from clinical trials to digital health to payors. Prior to joining Surgo, Ms. Kemp worked with Deloitte consulting as well as directly for the US government. She has a BA from the University of Virginia and an MPA from George Washington University. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.