Friends of Cancer Research

Overturning of the Chevron deference by the SCOTUS— what does it all mean? Our VP of public affairs, Ryan Hohman, delves into the implications this ruling has for the FDA and patient access to innovative #cancer therapies.  Read the full Q&A with Ryan: https://lnkd.in/e7iz9uwG Can’t view video? Watch on YouTube:  https://lnkd.in/etuhxZDU 

Register today! Friends’ Annual Meeting 2024 will explore three key topics focused on streamlining trial designs, enhancing data collection for oncology drug approvals, and supporting efficient regulatory processes and decision-making:  > Interim Overall Survival Evaluations and Implications for Trial Designs and Analysis Plans    > Enhancing Post-Marketing Studies with Pragmatism  > A Common Strategy for Using ctDNA as an Intermediate Endpoint in Prospectively Designed Trials Click the link to register and stay tuned for updates! Bit.ly/3JnEn8X  #FriendsAM24

Thrilled to work with this team and to bring the first pragmatic trial to our Smilow-Yale Network for lung cancer patients.

Our recent ESMO - European Society for Medical Oncology perspective addresses the question: Why and how can including pragmatic elements in clinical trials achieve more efficient, relevant, and patient-centered drug development?  Conventional Clinical Trials: Controlled Conditions, Stricter Eligibility - Conventional clinical trial designs often have highly controlled conditions with strict eligibility criteria. These trials test new treatments with limited safety data, which requires a more homogenous population of patients. While the trial is more controlled, with less variability of heterogeneous populations to measure treatment effects, many patients are excluded from joining the trial. Conventional clinical trials also have more cumbersome and complex protocols, limiting where the trial can be conducted, and reducing the ability for diverse patient populations to gain access.  Pragmatic Trials: Broader Patient Populations, Enhancing Trial Results - Trials that incorporate pragmatic elements can lead to results that are applicable across broader, more diverse patient populations.  In addition to broadening eligibility criteria, hallmarks of pragmatic elements include flexibility in treatment delivery (dosing and administration), integration intro routine clinical practices (simplified study protocols), and use of real-world data and real-world evidence in assessing outcomes (Electronic Health Records and Patient Reported Outcomes).  Read through the Friends of Cancer Research perspective in ESMO – European Society for Medical Oncology Real-World Data and Digital Oncology to learn more: https://bit.ly/4cAkUOz Thank you to our authors: Mark Stewart, Amy McKee, Roy Herbst, Hillary Andrews, PhD, Brittany Avin McKelvey, Ellen Sigal, Jeff Allen.

Friends of Cancer Research's Director of Regulatory Affairs Brittany Avin McKelvey spoke at the 14th World Clinical Biomarkers & Companion Diagnostics Summit discussing, “Leveraging Digital Biomarkers & Spatial Biology to Revolutionize Precision Medicine.” The panel discussion focused on the following topics.   - How can we standardize and integrate diverse digital biomarker data for comprehensive patient monitoring?   - How can predictive analytics with digital #biomarkers enhance personalized treatment plans?  - How should biopharma form effective partnerships to pioneer new technologies, such as AI-driven #digitalpathology? Dr. McKelvey was joined by: Todd Neville, Douglas P. Clark, MD and Javier Perez. Click to learn more about the panel and panelists: https://lnkd.in/eNv_Yp2P  Visit Friends #digitalPATH project page here: https://lnkd.in/gGU8t3VK 

Just published! Check out our commentary on pragmatic clinical trials in oncology, published in ESMO - European Society for Medical Oncology Real World Data and Digital Oncology. Read the commentary: https://bit.ly/4cAkUOz Incorporating pragmatic elements enhances data relevance and patient diversity but comes with challenges like balancing scientific rigor with real-world applicability. Our work here isn't done, and Friends of Cancer Research will be delving into this during our Annual Meeting on November 12, 2024 in Washington, DC. So stay tuned! Co-Authors: Mark Stewart, Amy McKee, Roy Herbst, Hillary Andrews, PhD, Ellen Sigal, Jeff Allen

NEW PUBLICATION: In our new article we describe how incorporating pragmatic elements into conventional clinical trials can enhance representativeness, increase accrual rates, and be less burdensome for participants and study sites. Read the full publication in ESMO - European Society for Medical Oncology Real World Data and Digital Oncology: https://lnkd.in/gFxeFdBS To build on this work, we will be hosting a session focused on pragmatic clinical trials design in the post-market setting at the Friends’ Annual Meeting 2024 - Registration & Info: https://lnkd.in/gmKnBbDN Thanks to Mark Stewart, Amy McKee, Roy Herbst, Hillary Andrews, PhD, Brittany Avin McKelvey, and Ellen Sigal for your insights! Receive regular updates: https://lnkd.in/dCvFvkeX #clinicaltrials #cancerresearch

Excited to share our latest commentary on enhancing regulatory decisions with pragmatic clinical trials (PCTs) in oncology, published in ESMO - European Society for Medical Oncology Real World Data and Digital Oncology. 📰 Read the full commentary here: https://bit.ly/4cAkUOz Key takeaways: -Emphasizes the value of PCTs in producing evidence that directly applies to clinical practice, moving beyond traditional explanatory trials. -Advocates for integrating pragmatic elements like broadened eligibility criteria and real-world data into clinical trials, to enhance data relevance and patient diversity. -Highlights the Pragmatica-Lung study as a successful case of integrating pragmatic elements to accelerate oncology drug development. -Discusses the importance of early regulatory engagement and alignment on the use of pragmatic trial elements. -Addresses challenges like balancing scientific rigor with real-world applicability, and the need for continued innovation in trial designs. Special thanks to my incredible co-authors: Amy McKee, Roy Herbst, Hillary Andrews, PhD, Brittany Avin McKelvey, Ellen Sigal, and Jeff Allen! Friends of Cancer Research continues to advance these important discussions and advancing the field of oncology drug development. Keep in eye out for more details on our upcoming Annual Meeting taking place November 12, 2024 in Washington, DC. #Pragmatictrials #RegulatoryInnovation #DrugDevelopment

New Friends of Cancer Research perspective in ESMO - European Society for Medical Oncology Real-World Data and Digital Oncology discusses the potential of incorporating pragmatic elements into conventional clinical trials to enhance their relevance and efficiency, particularly in #oncology drug development.  https://bit.ly/4cAkUOz    Our perspective describes the benefits of pragmatic clinical trials (PCTs) and how sponsors can incorporate pragmatic elements within conventional clinical trials to meet certain research goals, creating a more hybrid approach. This helps better reflect real-world conditions while aligning with regulatory frameworks. Case Study: Our perspective included Pragmatica-Lung as a case study in PCTs.     Pragmatica-Lung is a clinical trial that was designed to evaluate a novel drug combination (ramucirumab + pembrolizumab) to confirm an Overall Survival (OS) benefit observed in the Lung-MAP trial.  Pragmatica-Lung included pragmatic elements:  - Broadening eligibility criteria  - Streamlining data collection   - Evaluating only OS and severe adverse events By focusing only on these design goals, Pragmatica-Lung reduced burdens on patients for routine visits and were able focus on key survival and safety signals. This resulted in a rapidly implemented PCT (7 months) now available at more than 500 sites across the NCTN of National Cancer Institute (NCI).  Why was this trial successful using pragmatic elements? Both products were approved for the same patient population with extensive safety/efficacy data, allowing the focus on broadening eligibility criteria and OS measurement.   Can this work for other trials? Yes, but there are other considerations for incorporating these types of pragmatic elements. Our perspective explores opportunities to create a more hybrid approach with some pragmatic elements while maintaining more robust methodologies, when necessary, to support regulatory decision-making. Early engagement with regulators is essential to align on these elements, especially considering available safety and efficacy data for the study drugs.      Read the perspective here: https://bit.ly/4cAkUOz    Thank you to our authors: Mark D. Stewart, Amy McKee, Roy Herbst , Hillary Andrews, PhD, Brittany Avin McKelvey, Ellen Sigal, Jeffrey D. Allen. Trial sponsors: National Cancer Institute (NCI), SWOG Cancer Research Network, Alliance for Clinical Trials in Oncology  Pragmatica-Lung is a phase 3 clinical trial for stage IV non-small cell lung cancer that aims to remove barriers to participation, allowing individuals with lower performance status, who better represent those with advanced lung cancer, to enroll. 

There is growing interest in using pragmatic clinical trials (PCTs) to bridge the gap between research and practice in oncology, as they more closely resemble real-world care and have potential to enhance outcomes.  Introducing pragmatic elements into clinical trials can, where appropriate:  - Streamline trial conduct and data collection  - Reduce the burden of clinical trials on patients and providers  - Facilitate the enrollment of more diverse trial populations This can potentially result in improved understanding of product effectiveness and safety in a population more representative of those affected by the disease.  Our previous work has explored the opportunity of PCTs and at times led to the establishment of trials incorporating pragmatic elements.  In 2014, Friends of Cancer Research, with our partners at the FDA, National Cancer Institute (NCI), NIH, FNIH, and other stakeholders, established Lung-MAP, a first-of-its-kind clinical trial model that uses a multi-drug, targeted screening approach to match patients with sub-studies testing investigational treatments based on their unique tumor profiles. Lung-MAP constantly adapts to the fast pace of science and the drug development landscape, studying new treatments as they become available. In 2022, encouraging results were reported from an arm of Lung-MAP investigating a novel drug combination (ramucirumab + pembrolizumab). With the robust safety and efficacy data for each treatment in the combination and the initial results from Lung-MAP, a trial called Pragmatica-Lung launched in 2023 as part of FDA’s Project Pragmatica. This PCT was designed to efficiently confirm results from the Lung-MAP study and support regulatory decision-making.  At the Friends of Cancer Research Annual Meeting 2023, we continued to explore ways to operationalize PCTs, building on our work with the Lung-MAP clinical trial, collaboration with the FDA Oncology Center of Excellence (OCE), and Pragmatica-Lung.  Our 2023 Annual Meeting White Paper details examples and case studies for including pragmatic elements in modern clinical trials. Read more here: https://lnkd.in/eJxQQhTE Stay tuned for our 2024 Annual Meeting topic on operationalizing incorporation of pragmatic elements in postmarket #trials. To register for #FriendsAM24 click here:  bit.ly/3JnEn8X    Watch the Panel discussion here, “Incorporating Pragmatic Trial Elements into Oncology Drug Development”: https://lnkd.in/evfV-P2v