The COVID-19 pandemic did not adversely affect clinical trial enrollment in gynecologic oncology trials at a single academic institution

2022 ◽  
Vol 164 (1) ◽  
pp. 18
Author(s):  
Courtney Bailey ◽  
Sharad Ghamande ◽  
Lynn Tran ◽  
Bunja Rungruang ◽  
Donna Wheatley ◽  
...  
2002 ◽  
Vol 10 (1) ◽  
pp. 28-35 ◽  
Author(s):  
Electra D. Paskett ◽  
M. Robert Cooper ◽  
Nancy Stark ◽  
Thomas C. Ricketts ◽  
Sara Tropman ◽  
...  

2014 ◽  
Vol 132 (1) ◽  
pp. 8-17 ◽  
Author(s):  
Thomas J. Herzog ◽  
Deborah K. Armstrong ◽  
Mark F. Brady ◽  
Robert L. Coleman ◽  
Mark H. Einstein ◽  
...  

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 128-128
Author(s):  
Ahmed Megahed ◽  
Gary L Buchschacher ◽  
Ngoc J. Ho ◽  
Reina Haque ◽  
Robert Michael Cooper

128 Background: Sparse data exists on the diversity clinical trial enrollment in community settings. This information is important to ensure equity of care and generalizability of results. Methods: We conducted a retrospective cohort study of members of an integrated healthcare system diagnosed with invasive malignancies (excluding non-melanoma skin cancers) between 2013-2017 to examine demographics of the oncology population compared to those who enrolled in a clinical trial. Logistic regression was used to assess correlates of clinical trial participation, comparing general and screened samples to enrolled sample. Odds ratios were adjusted for gender, geocoded median household income, cancer type, and stage. Results: Of the 84,977 patients with a cancer diagnosis, N = 2606 were screened for clinical trial participation and consented, and of those N = 1372 enrolled. The percent of Latinx (25.8% vs 24.0%; OR 0.9? CI 0.72-1.05) and African American/Black (10.9% vs 11.1%; OR 0.92 CI 0.75-1.11) clinical trial participation mirrored that of the general oncology population, respectively using Non-Hispanic Whites as reference. Asian/Pacific Islander had equal odds of clinical trial enrollment (OR 1.08 CI 0.92-1.27). The enrolled population was younger than the general oncology population. Conclusions: This study suggests that in an integrated healthcare system with equal access to care, the clinical trials population is well representative of its general oncology population.[Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9005-9005
Author(s):  
Debora S. Bruno ◽  
Lisa M. Hess ◽  
Xiaohong Li ◽  
Eric Wen Su ◽  
Yajun Emily Zhu ◽  
...  

9005 Background: Cancer racial disparities may exist at many levels in the health care system, from screening to timely diagnosis and treatments received, as well as clinical trial enrollment. This study investigated differences in black versus white race among patients with NSCLC undergoing biomarker testing and clinical trial enrollment in the US. Methods: This retrospective observational study utilized the Flatiron Health database, which includes longitudinal data of patients with advanced/metastatic NSCLC. Patients were eligible if they had evidence of systemic therapy in the database from 1/1/2017 through 10/30/2020. Descriptive analyses summarized differences by race in biomarker testing and trial enrollment. Multivariable regression examined the relationship between these factors. Results: A total of 14,768 patients were eligible: 9,793 (66.3%) were white and 1,288 (8.7%) were black. 76.4% of white patients and 73.6% of black patients underwent at least one single molecular test or comprehensive genomic analysis (p = 0.03). Next-generation sequencing (NGS) was performed among 50.1% of white patients and 39.8% of black patients (p < 0.0001. Trial participation was observed among 3.9% of white and 1.9% of black patients (p = 0.0002). There was a statistically significant association between race (white vs black) and both biomarker testing (ever vs never) and trial participation (yes vs no) (both p < 0.001, unadjusted chi square). Differences in NGS testing, baseline biomarker testing, and race were retained as statistically significant (p < 0.01) in adjusted regression analyses. The receipt of first-line targeted therapy was comparable between white and black patients (10.2% and 9.2%, respectively, p = 0.24); however, this summary did not consider biomarker test results. First line use of pembrolizumab+carboplatin+pemetrexed was observed among 19.8% of white and 22.6% of black patients; carboplatin+paclitaxel was observed among 16.5% and 18.6%, and single-agent pembrolizumab was observed among 14.8% and 11.5%, respectively. Conclusions: The use of NGS-based testing, which is recommended by the National Comprehensive Cancer Network Clinical Guidelines in Oncology for patients with advanced/metastatic NSCLC, is the most notable disparity among black patients, with more than a 10 percentage-point difference in receipt of this testing versus white counterparts. This may in part contribute to the more than double the rate of participation in clinical trials observed among white patients, as many second line and beyond trials utilize molecular targets as inclusion criteria. While multiple factors are known to impact health care disparities, access to and receipt of appropriate biomarker testing may be an attenable goal in order to ensure equal access to quality care.


Geriatrics ◽  
2018 ◽  
Vol 3 (4) ◽  
pp. 85 ◽  
Author(s):  
John Ogden ◽  
Hao Xie ◽  
Wen Ma ◽  
Joleen Hubbard

Pancreatic cancer is the eleventh most common cancer, yet it is the third leading cause of mortality. It is also largely a disease of older adults, with the median age of 71 at diagnosis in the US, with <1% of diagnoses occurring prior to age 50. Current NCCN guidelines recommend surgery for localized disease, followed by adjuvant therapy and/or consideration of enrollment in a clinical trial. For metastatic disease, current guidelines recommend clinical trial enrollment or systemic chemotherapy based on results from the landmark ACCORD-11 and MPACT trials. However, these trials focused heavily on younger, more fit patients, with the ACCORD-11 trial excluding patients over age 75 and the MPACT trial having 92% of its patients with a Karnofsky performance score >80. This article summarizes the available evidence in current literature in regards to the best treatment options for older adults, who represent the majority of pancreatic cancer diagnoses.


Hematology ◽  
2021 ◽  
Vol 2021 (1) ◽  
pp. 226-233
Author(s):  
Lindsey A. George

Abstract After 3 decades of clinical trials, repeated proof-of-concept success has now been demonstrated in hemophilia A and B gene therapy. Current clinical hemophilia gene therapy efforts are largely focused on the use of systemically administered recombinant adeno-associated viral (rAAV) vectors for F8 or F9 gene addition. With multiple ongoing trials, including licensing studies in hemophilia A and B, many are cautiously optimistic that the first AAV vectors will obtain regulatory approval within approximately 1 year. While supported optimism suggests that the goal of gene therapy to alter the paradigm of hemophilia care may soon be realized, a number of outstanding questions have emerged from clinical trial that are in need of answers to harness the full potential of gene therapy for hemophilia patients. This article reviews the use of AAV vector gene addition approaches for hemophilia A and B, focusing specifically on information to review in the process of obtaining informed consent for hemophilia patients prior to clinical trial enrollment or administering a licensed AAV vector.


Author(s):  
Bernard M. McGarvey ◽  
Nancy J. Dynes ◽  
Burch C. Lin ◽  
Wesley H. Anderson ◽  
James P. Kremidas ◽  
...  

2017 ◽  
Vol 147 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Thomas J. Herzog ◽  
Gwynn Ison ◽  
Ronald D. Alvarez ◽  
Sanjeeve Balasubramaniam ◽  
Deborah K. Armstrong ◽  
...  

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