Research

Empowering Healthcare with Real-World Evidence

Dive into our repository of groundbreaking research papers, where we merge clinical expertise with data driven insights to revolutionize patient care and treatment strategies.

Group 79
Sharlene Dong, MD, Ankit Kansagra, MD https://orcid.org/0000-0001-6901-0782, Gurbakhash Kaur, MD https://orcid.org/0000-0002-2510-6536, Anna Barcellos, MPH, Andrew J. Belli, MPH, Laura L. Fernandes, PhD, Eric Hansen, MS, Jacob Ambrose, MS, Claire Bai, MS, Christina M. Zettler, MPH, and Ching-Kun Wang, MD
Our study found that a composite mortality variable leveraging multiple data sources yields high validity when compared against the gold-standard NDI. Given evidence highlighting the challenges of mortality data documentation in the real-world setting, the use of a composite mortality variable can provide significant benefits in quality of documentation and research results.
Matthew S. Davids, Jacob Ambrose, Enrico de Nigris, Jennifer Prescott, Siyang Leng,Mohammed Z. H. Farooqui,4 Shravanthi R. Gandra,6 Christina M. Zettler, Laura L. Fernandes, Ching Kun Wang, and Mazyar Shadman
Overall, our data help to better understand the rapidly evolving treatment paradigm for ≥2L CLL in the rw setting. Although there has been steady uptake of targeted therapies across LOTs, unmet need persists for patients with CLL/SLL who receive later LOTs. Our study demonstrates deterioration in outcomes, including rwPFS and rwOS, as patients advance to later LOTs, even after the approvals of targeted therapies, and highlights the meaningful proportion of patients who discontinue targeted agents because of toxicity. As such, our data highlight the persistent unmet need for new and effective treatment options to improve health outcomes for patients with CLL who have received ≥2L LOTs.
John Marshall, Anteneh A. Tesfaye, Connor Shimberg, Chelsea Perelgut, Jialing Zhu, and Chiranjeev Dash
Contrary to our expectations of finding significant cancer care disparities, we did not observe any differences in molecular tumor testing rates, time to initiation of therapy, or short-term survival by treatment site or race/ethnicity status. Our results suggest that integrated, specialized, guideline-concordant care in comprehensive cancer centers has the potential to eliminate CRC outcome disparities among pts diagnosed at these centers.
Levy N1, Campbell U1, Sheridan P1, Lenis D2, Madsen A3, O’Doherty I1, Estrin A4, Iyer M1, McDonald S3, Becnel L5, Belli A6, Carrigan G7, Chan KA8, Chen J9, Chia VM10, Dhopeshwarkar N11, Eckert JC12, Fernandes L13, Goldstein M14, Greshock J15, Hendricks-Sturrup R16, Huang J17, Jiao X18, Khosla S19, Lunacsek O20, McRoy L21, Natanzon Y22, Ovbiosa O23, Pace ND23, Pinheiro S23, Quinn J24, Rees M25, Rider J26, Rimawi M27, Robinson T25, Rodriguez-Watson C28, Sangli C29, Sarsour K15, Schneeweiss S30, Shapiro M31, Stewart M32, Taylor A17, Wang C6, Wasserman A24, Zhang Y19 1Aetion, Inc, New York, NY, USA, 2Aetion, Inc., NY, NY, USA, 3Aetion, Inc, Brooklyn, NY, USA, 4Aetion Inc., New York, NY, USA, 5Pfizer, New York, NY, USA, 6COTA, Inc, Boston, MA, USA, 7Amgen Inc., Thousand Oaks, CA, USA, 8TriNetX, LLC, Cambridge, MA, USA, 9Tempus, Chicago, IL, USA, 10Amgen Inc, Thousand Oaks, CA, USA, 11TriNetX, Cambridge, MA, USA, 12Reagan-Udall Foundation for the Food and Drug Administration, Washington, DC, USA, 13ConcertAI, New York, NY, USA, 14XCures, oakland, CA, USA, 15Johnson and Johnson, New Brunswick, NJ, USA, 16Duke-Margolis Center for Health Policy, Washington, DC, USA, 17Gilead Sciences, Foster City, CA, USA, 18Duke Margolis Center, Washington, DC, USA, 19AstraZeneca, Gaithersburg, MD, USA, 20Bayer, Whippany, NJ, USA, 21Pfizer, Inc., New York, NY, USA, 22ConcertAI, Cambridge, MA, USA, 23AbbVie, North Chicago, IL, USA, 24xCures, Oakland, CA, USA, 25Loopback Analytics, Dallas, TX, USA, 26Aetion, Inc, Boston, MA, USA, 27Baylor College of Medicine, Houston, TX, USA, 28Reagan-Udall Foundation for the FDA, Washington DC, DC, USA, 29Tempus AI, Inc., Chicago, IL, USA, 30Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA, 31xCures, DURHAM, NC, USA, 32Friends of Cancer Research, Washington, DC, USA
Oncology RCT emulations require specific eligibility criteria and outcomes that make identifying fit-for-emulation RWD especially challenging. In particular, routinely-captured, non-cancer diagnosis/treatment variables are absent from datasets containing high-quality oncology information. Rigorous feasibility assessments are critical for identifying fit-for-emulation RWD, contextualizing results, and identifying gaps in existing datasets.
Reshma L. Mahtani and Co-Author(s): Ana Sandoval -Leon, Maria Abreu, Elysse Castro-Hall, Ching-Kun Wang, Chelsea Perelgut, Christina M. Zettler, Gerardo Fernandez, Marcel Prastawa, Jack Zeineh, Aaron Feliz, Juan Carlos Mejias, Alex Shtbasky, Xiaozhu Zhang, Abishek Sainath Madduri, Brandon Veremis, Michael J. Donovan, Manmeet S. Ahluwalia
The results support the equivalence of PDxBR vs. ODX in providing prognostic information regarding the risk of recurrence for pts with early stage IBC. The NPV of 93 along with comparable specificity, event classification and use of risk directed adjuvant therapy supports the use of this assay to provide a standardized AI-enabled grade and phenotype of IBC. This information may enhance overall risk discrimination when used in conjunction with genomic assays which also provide important predictive results that aid in decisions regarding the use of adjuvant chemotherapy. Additional studies are underway to further confirm these proposed clinical applications.
Kim Linton, John N. Allan, MD, Andrew S Park, PhD MPH, Anthony W Wang, PhD MPH, Summer Tran, PharmD, PhD, Alex Mutebi, PhD, Zhijie Ding, PhD MS, MBA, Quan Chen, DrPH, MS, Tycel J. Phillips, MD
Mortality rates increased during the years of the COVID-19 pandemic, peaking in 2021 and 2022, coinciding with the Omicron variant. As anticipated, the 65+ year age group and patients initiating new therapy experienced elevated mortality rates compared with patients under 65 years of age and those not initiating new therapies. Thus, COVID-19 substantially reduced survival of patients with FL and could have confounded survival outcomes in clinical trials, especially those conducted during the Omicron variant.
Shaji Kumar MD, Sundar Jagannath, Katja C. Weisel MD, Laura Rosiñol Dachs, Meletios-Athanasios Dimopoulos, David S. Siegel MD PhD, Jorge Monge MD, Xavier Leleu, Juan Du, Javier de la Rubia, Jae Hoon Lee, María-Victoria Mateos, Borja Puertas Martínez, Alessandro Gozzetti, Dominik Dytfeld, Enrique M. Ocio, Joan Bladé MD PhD, Shuji Ozaki, Meral Beksac MD, Fernando Escalante, Brian G.M. Durie
Linvoseltamab induced better ORR vs RW SOC treatments overall, and better or similar ORR in the key subgroups assessed, highlighting its therapeutic value across a range of patients with RRMM with heterogeneous risk profiles and levels of disease burden.
Javier Munoz MD, Allison C. Rosenthal DO, Andrew Ip MD, Justin M. Darrah MD, Tongsheng Wang MS, Guihua Zhang MS, Alex Mutebi PhD, Monika Jun MPH, Zhijie Ding PhD MS, MBA, Anindit Chhibber PhD, Fernando Rivas Navarro MD PhD, Malene Risum MD PhD, Mohammad Atiya PharmD, Samantha Brodkin DO, Anthony W Wang PhD MPH, Abualbishr Alshreef PhD, Diala Harb PharmD, PhD, Mariana Sacchi MD, Daniela Hoehn MD PhD, Yasmin H. Karimi MD
In this indirect treatment comparison analysis,Epcor+GemOx provided significantly superior efficacy benefits in terms of ORR, CR, PFS, and OS vs standard-of-care R-GemOx. While subject to the limitations of comparisons outside of controlled trials, findings indicate the compelling efficacy of Epcor+GemOx as a novel therapeutic option for transplant-ineligible patients with R/R DLBCL.
Luciano J. Costa MDPhD, Thomas W. LeBlanc MD MA, MSH, Hans Tesch, Pieter Sonneveld MD, Sarasa M.A. Johnson, Francis Vekeman, Patrick Hlavacek, Aster Meche, Paul Cislo, David Hughes, Guido Nador, Marco DiBonaventura
Among BCMA-naïve patients who resemble those enrolled in the MM-3 trial, those treated with ELRA exhibited significantly longer PFS, DOR, and OS compared with treatments currently used in RW clinical practice.
Paul A. Hamlin, MD, Pallawi Torka, MD, Eric Hansen, MS, Andrew J. Belli, MPH, Jacob Ambrose, MS, Christina M. Zettler, MPH, Laura L. Fernandes, PhD, Stephanie Wiley, RN, OCN, Brittney Perry, RN, OCN, Ching-Kun Wang, MD
Older adult pts who initiated treatment rapidly (0-2 weeks from diagnosis) had significantly worse rwTTNT and rwOS, underscoring the need for representativeness and generalizability of clinical trial results given the potential for selection bias if these pts are unable to enroll in clinical trials. Additionally, data such as these can help anchor expected survival data for trial control groups more realistically by utilizing estimates from the cohorts with DTI > 2 weeks.