Accountable Care in 2027: Building the Evidence Base and Driving Practical Policy Solutions (+... +...)

RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations

RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations (+... ... ...) video and more

This public workshop, co-convened by Duke Margolis and the FDA Rare Disease Innovation Hub, will explore statistical considerations in the design, conduct, and analysis of clinical investigations for rare disease medical products. The small patient populations inherent to rare disease present unique challenges that increase the risk of obtaining inconclusive trial results. Addressing these challenges requires careful attention to statistical rigor while utilizing tailored approaches that are necessary to make medical product development feasible in this space. Reliable and timely evidence that relies on data from all available information is critically important to patients and families affected by rare diseases, making the optimization of clinical investigation design, conduct, and analysis a matter of both scientific and ethical urgency. The workshop will focus on key statistical considerations for tailored approaches employed across the full arc of rare disease development programs. Topics will include the role of randomization and blinding, strategies for enhancing efficiency, and factors specific to medical devices. Discussions will explore these statistical considerations with the goal of identifying efficient approaches that maintain scientific rigor and produce meaningful results for rare disease product development. Statistical considerations affect every aspect of drug development, testing, and review, including clinical trial design and measuring product effectiveness; understanding the role of statistical review is important for sponsors, patients, and disease advocates alike. All members of the rare disease community, regardless of prior familiarity with statistical approaches, are encouraged to attend. https://healthpolicy.duke.edu/events/rise-challenge-statistical-considerations-rare-disease-clinical-investigations?utm_medium=email&utm_source=govdelivery Patient Voice in Rare Disease Medical Product Development October 16, 2026 https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/patient-voice-rare-disease-medical-product-development-10162026?utm_medium=email&utm_source=govdelivery FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development Effort begins by Soliciting Public Feedback https://www.fda.gov/news-events/press-announcements/fda-launches-rare-disease-framework-initiative-develop-holistic-fit-purpose-framework-rare-disease?utm_medium=email&utm_source=govdelivery A New Framework for Rare Disease Review October 2026 https://www.fda.gov/media/195694/download?attachment=&utm_medium=email&utm_source=govdelivery FDA Rare Disease Framework Initiative Public Meeting October 28, 2026 https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-rare-disease-framework-initiative-public-meeting-10282026?utm_medium=email&utm_source=govdelivery CDRH Rare Disease Impact Initiative https://www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-rare-disease-impact-initiative?utm_medium=email&utm_source=govdelivery

FDA Rare Disease Day 2027 March 5, 2027

https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-rare-disease-day-2027-03052027?utm_medium=email&utm_source=govdelivery

New Pathways in Antithrombotic Therapy Authors: Geoffrey D. Barnes, MD, MSc; Carolyn S. P. Lam, MBBS, PhD; Christian T. Ruff, MD, MPH

https://www.medscape.org/viewarticle/new-pathways-antithrombotic-therapy-2026a1000gtd?page=1&src=mkmcmr_driv_stan_mscpedu_261027-OUS-HONC-new-pathways-antithrombotic-therapy-2026a1000gtd-cta&uac=148436CN

Advancing the DLBCL Paradigm Sequencing Bispecifics in Optimizing Patient Care CME New Orleans Ernest N. Morial Convention Center Friday, December 11, 2026 | 7:30 pm - 9:00 pm CT

https://na.eventscloud.com/website/98542/ Join this engaging, interactive symposium exploring the rapidly evolving landscape of bispecific antibodies in diffuse large B-cell lymphoma (DLBCL). Leading international experts will dive into topline clinical evidence across second- and third-line settings and frontline horizons, evaluating pivotal trial data in transplant-ineligible and high-risk populations. Through real-world clinical case scenarios, the panel will debate treatment sequencing—weighing bispecifics against chimeric antigen receptor (CAR) T-cell therapy, individualizing care based on patient fitness and geographic access, and assessing impacts on T-cell fitness. Furthermore, faculty will address key practicalities for integrating bispecific therapies into community practice, from managing safety and treatment logistics to streamlining care coordination and patient pathways. Walk away with concrete solutions to optimize sequencing, safety, and care delivery across the DLBCL continuum. Friday Satellite Symposium on Hematology, preceding the 68th ASH Annual Meeting and Exposition

Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV

https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/whats-new

From Evidence to Impact: Winning Case Studies from The Lancet–Elsevier Foundation Awards Wednesday, 18/11/2026 · 05:00 Atlantic Time (Canada) (GMT -4:00) Cost: Free

https://www.bigmarker.com/lancet-webinars/from-evidence-to-impact-winning-case-studies-from-the-lancet-elsevier-foundation-awards?utm_bmcr_source=hubspot_email_reg1_lancetelsevierfoundationawards26&_hsmi=446218158&_hsenc=p2ANqtz-_96WygM0EjD8Ov_35nL97V2Z8dan221ZFKebJveTSXmHSi56waQzyfn4wtWBqtis78TMMXZCq6ibXN3_Y1VA7kiDcCBQ&hsCtaAttrib=222131459929 We invite you to our Lancet Webinar, From Evidence to Impact: Winning Case Studies from The Lancet-Elsevier Foundation Awards, on November 18, 2026, at 09:00 GMT/10:00 CET, presented in partnership with The Elsevier Foundation. Attendance is free with registration. Register now Chaired by Zoë Mullan, Editor-in-Chief of The Lancet Global Health, and Maha Rhannam, Elsevier Foundation Partnerships Manager, hear from the three winning teams of the inaugural The Lancet-Elsevier Foundation Evidence to Impact Awards as they share learnings from their award-winning projects, showcasing implementation science in practice from around the world. Although the subject matter and settings are very different, all three demonstrate a deep commitment to community engagement, co-design, evidence-based implementation strategies, and sustainability via long-term partnerships. Hear from the winners: Implementing Essential Emergency and Critical Care in Tanzania Tim Baker, Associate Professor and Critical Care Physician, and Anesthesiologist, Muhimbili University of Health and Allied Sciences, and Karolinska Institutet, Tanzania Karima Khalid, Lecturer and Senior Consultant in Anaesthesia and Critical Care, Muhimbili University of Health and Allied Sciences and Muhimbili Orthopaedic Institute, Tanzania 2YoungLives: Reducing Adolescent Maternal and Perinatal Mortality in Sierra Leone Cristina Fernandez Turienzo, Senior Research Fellow in Maternal, Child and Adolescent health, PI, King’s College London, UK Mangenda Kamara, 2YoungLives Co-Founder and gender expert, University of Sierra Leone & Lifeline Nehemiah Projects, Sierra Leone The ECORRA Trial: Equitable Cancer Outcomes across Rural and Remote Australia Serene Yoong, Associate Professor and Co-Director of the Deakin Centre for Global Preventive Health and Nutrition (GLOBE), Deakin University, Australia Anna Chapman, Senior Research Fellow, Deakin University, Australia You will also have the opportunity to ask your questions during a live Q&A with each of the winning teams. Can't attend the live webinar? By registering you will receive an email with a link to the on-demand version so that you can watch it at your convenience. We hope you can join us for this Lancet Webinar! Yours sincerely, The Lancet Group