Wesley Burks, MD

Last year, CCF team members Stacie Lindsey and Melinda Bachini along with colleagues in the field Rachna Shroff, MD, FASCO and Wendy Selig, authored the #whitepaper "Cross-over arms in oncology clinical trials: An important consideration for patients," highlighting a revolutionary approach to designing cancer clinical trials. The paper emphasizes the importance of patient-centric trial designs and introduces the concept of "cross-over" options, opening new doors for patients with limited treatment options. It also encourages sponsors, investigators, and regulators to advance patient-centric trial designs. This initiative is crucial for our CCF community as it represents a significant step forward in #cholangiocarcinoma cancer research and patient care. Read more about the whitepaper here: https://lnkd.in/eRJ_TY3h. #CCAhope #cureCCA #bileductcancer #ClinicalTrials #NationalCancerResearchMonth #PatientPoweredResearch See less

38

📢New article alert from the Journal of Comparative Effectiveness Research:   First in class, best in class or a wild card: who will dominate the anti-obesity medication market?   This editorial explores the factors influencing the success of anti-obesity medications (AOMs) in a market expected to grow significantly by 2035. It examines the roles of clinical efficacy, patient preferences, and market access, suggesting that a combination of factors will determine the leading AOMs rather than solely 'first-in-class' or 'best-in-class' labels.   Authors: Emma Collins, CFA, Alice Beattie, Sreeram Ramagopalan & Jonathan Pearson-Stuttard (LCP)   #heor #AntiObesity #GLP1 #MarketAccess

6

🧠 Check out this research from Zachary A. Bacigalupa, PhD, and colleagues investigating the effects of #ACSS2 on HIF-2α, #cancer metabolism, and cancer growth in patients with #ccRCC. 📚 Read More: https://buff.ly/4eTDjIC

3

Integrating trials and health care is a critical need. Glad to see this addressed so directly in a new way

6

Healio had the pleasure of speaking with Clyde Yancy, one of the most prominent KOLs in #cardiology, on a variety of topics at the American College of Physicians Internal Medicine Meeting. Check out a summary of what he told us below, at the bottom of which there are links to six videos that he shot with us. Northwestern University - The Feinberg School of Medicine The topics he discussed include: ❤️ Cardio-kidney-metabolic syndrome ❤️ Social determinants of health ❤️ The heart-related benefits of the newer weight-loss drugs ❤️ The promise of small interfering RNA technology in heart care ❤️ Using incidental calcification findings to assess heart disease risk ❤️ The benefits of following the American Heart Association's Life Essential 8 lifestyle parameters https://lnkd.in/egv_RtGp

12

While #ASCO24 is at an end, it was great following all of it on social media. If you were at ASCO and interested in potential collaborations with the journal Technology in Cancer Research & Treatment, please feel free to reach out. Thanks for sharing OncoDaily! #cancer #oncology #cancerresearch #oncodaily

5

Here are the details！

1

Estimands - Bridging the gap between the real world and statistics: With all that was going on in 2020, you may have missed one of the largest updates to the ICH guidelines - The addendum to "ICH E9 Statistical Principals for Clinical Trials" that contained the official introduction to a new element of statistical trials - The Estimand. The Estimand aims to appropriately and accurately understand the treatment effect that is TRULY of interest within the clinical study. It turns out that when you conduct a clinical trial - not every subject is going to follow the protocol exactly, not every measure is going to be recorded, and a whole slew of other events are going to occur which may make interpreting the results not so straightforward. When these events occur to a subject, and when they happen to enough subjects, it changes the research question that is being asked and answered by the statistical analysis. For example - if enough subjects take emergency medication throughout the trial and you analyze the final data to see if there is a treatment effect - you may not be looking cleanly at the treatment effect - you may be looking at the treatment effect + emergency medication usage. The Estimand aims to account for these Intercurrent Events (ICEs) that occur throughout the clinical trial which muddy the questions being asked and the answers generated. The Intercurrent Events (the events I kept talking about above) are THE key factors in creating and evaluating Estimands. If we can understand and plan for those events that are likely to occur in our clinical trial, we can be more systematic and produce more meaningful clinical trial results. I have several more posts coming this week and next all about the Estimand followed by a LinkedIn Live event dedicated to a discussion around Estimands (with examples!) with the one and only Darko Medin on June 25 (Link in the comments). Stay tuned to learn all about Estimand. Happy Monday

107

9 Comments

The recent study published by Ron Alfa, MD, PhD et al. shows that tempol (REC-994) is well tolerated with no dose-limiting adverse events, even at the highest dose of 800 mg, in a phase 1 clinical trial. These findings support advancing to a phase 2 clinical trial for symptomatic cerebral cavernous malformation patients. 💊 Read more in Pharmacology Research & Perspectives : https://lnkd.in/gJQQjgbf #CerebralCavernousMalformation #CCM #ClinicalTrial #Pharmacology #MedicalResearch #Tempol #REC994 #Neurology #StrokePrevention #DrugDevelopment #HealthScience #Phase1Trial #ClinicalStudies #MedicalAdvancement

20

1 Comment

Shared decision-making fundamentally requires that physicians have aligned their interprofessional perspectives. I talk about this challenge in an article that just appeared in JPSRM: https://lnkd.in/gBim_n_X Enjoy! #patientsafety #SharedDecisionMaking

6

#proud of my postdoctoral fellow Patrice Forrester who is first author on work with a patient, Ontada and McKesson! We propose principles to guide #oncology #realworldevidence research protocols to address #socialdeterminantsofhealth in community settings and promote health under three overarching categories (1) education; (2) community engagement; and (3) research design and implementation.

76

4 Comments

Phase I #clinicaltrial #earlydrugdevelopment update from AdventHealth Central Florida #cancer institute, #Orlando/Celebration #Florida -Our rapidly growing Phase I Clinical Research Unit offers new cutting edge #cancer therapies to the highly diverse and expanding community of central Florida-Delighted to offer several promising novel agents #immunotherapy #targetedtherapy #antibodydrugconjugates to treat advanced cancer- pleased to report that our efforts thanks to our great team Lindley ‘’Lei’’ Mosqueda, APRN, AOCNP Charmaine Garcia, MD, CCRC & many others have improved access to novel therapies in #Florida & led to many presentations including coauthoring 2 oral presentations within a year: ESMO - European Society for Medical Oncology #ESMO23 & the upcoming American Society of Clinical Oncology (ASCO) #ASCO24: 1) SGN-B7H4 (ADC targeting B7H4) Seagen: https://lnkd.in/eManaDAy, 2) SRK-181 by Scholar Rock (Latent TGFβ1 inhibitor)+ pembrolizumab: https://lnkd.in/eFSQT8Ug; Furthermore-pleased to lead this ongoing Phase I trial of PARP1 inhibitor IMP1734 by Eikon Therapeutics -being presented as a trial in progress https://lnkd.in/ej9qnZe9 #ASCO24

95

3 Comments

📢New article alert from the Journal of Comparative Effectiveness Research:   Title: Evaluation of inpatient and emergency department healthcare resource utilization and costs pre- and post-nusinersen for the treatment of spinal muscular atrophy using United States claims   A new study from Johnson et al. evaluates the impact of nusinersen on healthcare resource utilization and costs for #SpinalMuscularAtrophy patients using US claims data, finding significant reductions in inpatient admissions and costs for both pediatric and adult patients post-treatment compared with pre-treatment.   Authors: Cong Zhu, Craig Zaidman, Bora Youn, Angela Paradis, ScD, Stéphanie Raynaud Delcroix, Bridget A Neville & Nicole Benjamin Johnson Biogen, Washington University School of Medicine in St. Louis   #SMA #Nusinersen #Healthcare #ClinicalOutcomes #HealthEconomics #Pharma 🔗 https://lnkd.in/ePcXF_B2

8

Some treatments (known as biologics) for asthma and allergies are delivered through injections that you do yourself. Dr. Dave Stukus shares tips to prepare yourself if you have needle phobia. (Part 1) Learn more about treatment options at aafa.org. This video series is a collaboration between AAFA and American Academy of Allergy, Asthma and Immunology - AAAAI https://lnkd.in/gaqymibS

7

1 Comment

I fully agree with the authors on the critical role that Cancer Centers play in advancing cancer treatment, translating discoveries into practice, and educating the next generation of physician-scientists. The Cancer Center Clinical Trials Office (CTO) serves as the hub of expertise, operations, and safety oversight for clinical research involving cancer patients. It supports all aspects of cancer clinical research operations, ensuring compliance with regulatory requirements and rigorous safety oversight while providing access to new experimental therapies for patients with cancer. A cancer center that better serves its patients and communities must have leadership that understands the critical role of a competent and resourceful Clinical Trials Office. It should not be downplayed or considered as just another administrative office. Cancer Centers should invest in a strong Clinical Trials Office. This is a win-win initiative that will become self-sustaining with a positive ROI. The CTO is at the core of an NCI-designated Cancer Center that offers state-of-the-art therapeutic alternatives for patients with cancer. #CancerResearch #ClinicalTrials #CancerTreatment

2

Despite significant advances in cancer therapies over recent decades, the United States grapples with growing disparities in cancer-related outcomes between its rural populations and urban and suburban counterparts. These disparities can be attributed, in part, to the centralization of oncology services within urban centers, which concomitantly imposes heightened travel demands on rural patients, constricting their access to comprehensive cancer treatment and specialized care. Historically, strategies such as the visiting consultant outreach model have been deployed to improve service accessibility, yet they offer only fragmented solutions to the multifaceted challenge of equitable care distribution. In response to this challenge, the authors introduce the rural oncology home, an alternative model for rural oncology care delivery. This innovative approach is centered on a community-based, team-oriented framework that incorporates medical specialists and emphasizes supportive services. By leveraging advanced practice professionals and care coordination, the model aims to enhance the accessibility of specialized cancer care for rural patients. Such models for rural oncology care delivery are emerging, with a pronounced emphasis on leveraging telehealth technologies. The Lakewood Health System Rural Oncology Home model can potentially create a more equitable system of cancer care delivery that can bridge the rural cancer gap and improve outcomes for rural patients with cancer: https://nej.md/3Q26Ncq

2