Article
Medicine, General & Internal
Katarzyna Szlezinger, Katarzyna Pogoda, Agnieszka Jagiello-Gruszfeld, Danuta Klosowska, Andrzej Gorski, Jan Borysowski
Summary: This study assessed the eligibility criteria in recent clinical trials for breast cancer. It found that many of these trials exclude large groups of patients, especially older adults, individuals with comorbidities, and those with poor performance status. Therefore, careful modification of these criteria is needed to evaluate the benefits and harms of investigational treatments in patients with characteristics commonly encountered in clinical practice.
Article
Clinical Neurology
Ryan E. Lawrence, Adam Bernstein, Chaya Jaffe, Yinjun Zhao, Yuanjia Wang, Terry E. Goldberg
Summary: Exclusion criteria commonly used in contemporary clinical trials of depression limit generalizability to emergency psychiatry patients, primarily due to exclusions for psychosis, substance use, and suicide risk.
JOURNAL OF AFFECTIVE DISORDERS
(2023)
Article
Computer Science, Information Systems
Jae Hyun Kim, Casey N. Ta, Cong Liu, Cynthia Sung, Alex M. Butler, Latoya A. Stewart, Lyudmila Ena, James R. Rogers, Junghwan Lee, Anna Ostropolets, Patrick B. Ryan, Hao Liu, Shing M. Lee, Mitchell S. Elkind, Chunhua Weng
Summary: This research evaluated the impact of eligibility criteria on recruitment and clinical outcomes of COVID-19 trials using EHR data. Adjusting the thresholds of common eligibility criteria based on COVID-19 patient characteristics resulted in observing more composite events from fewer patients. This supports data-driven optimization of participant selection for improved statistical power of COVID-19 trials.
JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION
(2021)
Review
Medicine, Research & Experimental
Qianmin Su, Gaoyi Cheng, Jihan Huang
Summary: The purpose of this paper is to systematically analyze the cutting-edge research on eligibility criteria of clinical trials. Inappropriate eligibility criteria can lead to insufficient recruitment and eventual failure of clinical trials. The global research on eligibility criteria is divided into four main aspects: natural language processing, patient pre-screening, standard evaluation, and clinical trial query. Future research will focus on improving artificial intelligence algorithms related to clinical trials and practical applications such as databases and knowledge graphs.
CLINICAL AND EXPERIMENTAL MEDICINE
(2023)
Article
Oncology
Andrea M. Denicoff, S. Percy Ivy, Tami T. Tamashiro, Jinxiu Zhao, Katherine H. Worthington, Margaret M. Mooney, Richard F. Little
Summary: The Cancer Therapy Evaluation Program (CTEP) at the US National Cancer Institute published a new protocol template language in 2018 to modernize eligibility criteria for cancer treatment trials. An analysis of CTEP-supported trials showed a relatively high implementation of eligibility criteria, ranging from 54.1% for prior and/or concurrent malignancies to 93.4% for HIV-related criteria. However, consistent implementation requires sustained effort, leading to a new initiative by CTEP to review and improve consistency with the modernization effort for new protocols.
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE
(2022)
Article
Oncology
Julie R. Park, Judith G. Villablanca, Barbara Hero, Brian H. Kushner, Keith Wheatley, Klaus H. Beiske, Ruth L. Ladenstein, Sylvain Baruchel, Margaret E. Macy, Lucas Moreno, Nita L. Seibel, Andrew D. Pearson, Katherine K. Matthay, Dominique Valteau-Couanet
Summary: This article aims to develop an international consensus to refine the tumor site eligibility criteria and evaluation of disease response for early-phase clinical trials in children with high-risk neuroblastoma. By standardizing data collection, eligibility criteria, and response evaluations, comparable data can be collected across international trials and effective treatment regimens for high-risk neuroblastoma can be identified more rapidly.
Article
Multidisciplinary Sciences
Ruishan Liu, Shemra Rizzo, Samuel Whipple, Navdeep Pal, Arturo Lopez Pineda, Michael Lu, Brandon Arnieri, Ying Lu, William Capra, Ryan Copping, James Zou
Summary: The study found that using a data-driven approach to broaden trial eligibility criteria can increase the number of eligible patients and decrease the hazard ratio of overall survival. Many patients who were initially not eligible under the trial criteria could potentially benefit from the treatments.
Article
Oncology
Roshal R. Patel, Rose Parisi, Vivek Verma, Ramez Kouzy, Joseph Abi Jaoude, Timothy A. Lin, Clifton David Fuller, Noam A. VanderWalde, Reshma Jagsi, Benjamin D. Smith, Beverly Ashleigh Guadagnolo, Charles R. Thomas Jr, Ethan B. Ludmir
Summary: Recent studies have found an increasing incidence of age disparities in cancer clinical trials. One eligibility criterion that may inadvertently exclude the elderly is the exclusion of patients with prior malignancies. While strict enrollment criteria may improve internal validity, they can negatively impact generalizability. This study aimed to characterize the incidence of prior malignancy exclusion criteria in phase III trials and assess their association with age disparities. The findings suggest that these exclusion criteria contribute to age disparities and updating the criteria may help reduce such disparities in clinical trial enrollment.
Article
Oncology
Clara Wan, Nicole E. Caston, Stacey A. Ingram, Gabrielle B. Rocque
Summary: Substantial heterogeneity was observed across laboratory values and comorbid variables among protocols. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.
BREAST CANCER RESEARCH AND TREATMENT
(2022)
Article
Medical Informatics
Hui Zong, Jinxuan Yang, Zeyu Zhang, Zuofeng Li, Xiaoyan Zhang
Summary: This study aimed to explore the semantic categories of Chinese eligibility criteria through analyzing clinical trials registration files from ChiCTR. A total of 44 types of semantic categories were developed by hierarchical clustering algorithms, and 13 novel categories were identified compared to English eligibility criteria. The classification results showed that the pre-trained language model ERNIE achieved the best performance with a macro-average F1 score of 0.7980 and a micro-average F1 score of 0.8484, indicating the potential for improving automated patient recruitment systems.
BMC MEDICAL INFORMATICS AND DECISION MAKING
(2021)
Review
Oncology
David E. Gerber, Harpreet Singh, Erin Larkins, Andrea Ferris, Patrick M. Forde, Wendy Selig, Upal Basu Roy
Summary: Clinical trial eligibility criteria play a crucial role in controlling patient characteristics, ensuring participant safety, and optimizing result interpretation. However, complex and overly restrictive criteria have posed barriers to patient access, recruitment, and the generalizability of trial results. In response, a working group developed a framework for lung cancer clinical trial eligibility criteria, aiming to simplify criteria, facilitate stakeholder search for trials, and harmonize trial populations for treatment effect comparisons.
Article
Oncology
Andrea N. Riner, Selamawit Girma, Vignesh Vudatha, Nitai Mukhopadhyay, Nevena Skoro, Tamas S. Gal, Devon C. Freudenberger, Kelly M. Herremans, Thomas J. George, Jose G. Trevino
Summary: This study investigated the impact of eligibility criteria on the participation of different racial groups in pancreatic ductal adenocarcinoma (PDAC) clinical trials. The results showed that traditional eligibility criteria disproportionately excluded Black patients from participating in the trials. Revised criteria may enhance participant diversity without compromising safety or study results.
JOURNAL OF CLINICAL ONCOLOGY
(2022)
Article
Mathematical & Computational Biology
Kaiyan Hu, Li Zhao, Qi Zhou, Fan Mei, Qianqian Gao, Fei Chen, Mengyao Jiang, Bing Zhao, Weiyi Zhang, Joey S. W. Kwong, Yuxia Ma, Chenghua Mou, Bin Ma
Summary: The majority of systematic reviews exhibit differences in study eligibility criteria, with many changes occurring in at least two key components, yet these changes are rarely explained. Results show that outcomes have the highest variation, while comparators have the lowest. Authors, the PROSPERO platform, peer-review journals, and reviewers should work towards improving transparency.
RESEARCH SYNTHESIS METHODS
(2021)
Review
Oncology
David Riedl, Maria Rothmund, Anne-Sophie Darlington, Samantha Sodergren, Roman Crazzolara, Teresa de Rojas
Summary: This study found that the use of patient-reported outcomes (PROs) is extremely rare in pediatric oncology clinical trials, with only 8.2% of trials using PROs as endpoints and .6% as the primary endpoint. Despite recommendations from regulatory agencies, there is a significant gap between the recommended and actual use of PROs, with only 20.3% of closed studies publishing their results. More efforts should be made to promote the implementation of PROs in pediatric trials to ensure patient-centered research and treatments.
EUROPEAN JOURNAL OF CANCER
(2021)
Article
Oncology
Kathrin Nachtkamp, Josefine Stark, Andrea Kuendgen, Thomas Schroeder, Corinna Strupp, Judith Strapatsas, Esther Schuler, Jennifer Kaivers, Aristoteles Giagounidis, Christina Rautenberg, Carlo Aul, Volker Runde, Rainer Haas, Guido Kobbe, Norbert Gattermann, Ulrich Germing
Summary: Participation in clinical trials for MDS patients is limited by strict inclusion and exclusion criteria, with the suggestion that criteria should be less restrictive to meet the needs of elderly MDS patients. The simulation study found that average eligibility for clinical trials was around 18% in the cohort, with karyotype, comorbidities, and prior therapies being the main reasons for exclusion. Pharmaceutical industry-initiated trials excluded more patients compared to investigator-initiated trials.
Article
Oncology
Yu Liu, Wenju Chang, Wentao Tang, Ye Wei, Tianyu Liu, Yijiao Chen, Meiling Ji, Fei Liang, Li Ren, Jianmin Xu
Summary: The study reported the treatment mode of rectal GISTs in the center, retrospectively analyzing patients with pathologically confirmed rectal GISTs who received neoadjuvant therapy and surgical resection. The results showed that neoadjuvant treatment led to significant tumor shrinkage without high complication rates, and patients had a high relapse-free survival rate after surgical resection.
CANCER MANAGEMENT AND RESEARCH
(2021)
Article
Oncology
Ling Peng, Wen-Hua Liang, De-Guang Mu, Song Xu, Shao-Dong Hong, Justin Stebbing, Fei Liang, Yang Xia
Summary: For PD-L1 negative NSCLC patients, nivolumab plus chemotherapy in combination with angiogenesis inhibition or anti-CTLA-4 therapy showed the greatest benefits among first-line treatment strategies based on Bayesian network meta-analysis. This personalized treatment approach may improve outcomes for patients, but individual safety considerations should be taken into account. Further validation is needed to confirm these findings.
FRONTIERS IN ONCOLOGY
(2021)
Article
Oncology
Rui Jin, Ling Peng, Jiawei Shou, Jin Wang, Yin Jin, Fei Liang, Jing Zhao, Mengmeng Wu, Qin Li, Bin Zhang, Xiaoying Wu, Fen Lan, Lixia Xia, Junrong Yan, Yang Shao, Justin Stebbing, Huahao Shen, Wen Li, Yang Xia
Summary: Patients with EGFR-mutant lung squamous cell carcinoma have shorter progression-free survival compared to those with EGFR-mutant lung adenocarcinoma, and their genomic profiles are associated with the efficacy of EGFR-TKIs.
FRONTIERS IN ONCOLOGY
(2021)
Review
Oncology
Yajing Wu, Vivek Verma, Fei Liang, Qiang Lin, Zhiguo Zhou, Zhiyu Wang, Yi Wang, Jun Wang, Joe Y. Chang
Summary: A systematic review with a meta-analysis comparing local consolidative therapy (LCT) and systemic therapy alone for metastatic non-small cell lung cancer (mNSCLC) showed that LCT may improve progression-free survival (PFS) and overall survival (OS) without increasing the risk of high-grade adverse events (AEs). However, further research is needed, specifically for polymetastatic mNSCLC, and the findings cannot be generalized to other histologies.
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS
(2022)
Review
Oncology
Ling Peng, Dafeng Lu, Yang Xia, Shaodong Hong, Giovanni Selvaggi, Justin Stebbing, Yilan Sun, Fei Liang
Summary: The network meta-analysis of frontline treatment options for ALK-positive NSCLC included 9 RCTs with 2,484 patients. Lorlatinib showed the highest PFS benefit and lowest risk of CNS progression, but also higher toxicity. The use of newer generation ALK-TKIs in first-line treatment for ALK-positive NSCLC is rapidly evolving in current clinical practice.
FRONTIERS IN ONCOLOGY
(2021)
Article
Gastroenterology & Hepatology
Guang-Yu Ding, Jia-Qiang Ma, Jing-Ping Yun, Xing Chen, Yu Ling, Shu Zhang, Jie-Yi Shi, Yu-Qing Chang, Yuan Ji, Xiao-Ying Wang, Wei-Min Tan, Ke-Fei Yuan, Bo Yan, Xiao-Ming Zhang, Fei Liang, Jian Zhou, Jia Fan, Yong Zeng, Mu-Yan Cai, Qiang Gao
Summary: The prognostic value and functional involvement of tertiary lymphoid structures (TLSs) in intrahepatic cholangiocarcinoma (iCCA) were evaluated. The study found that the spatial distribution and abundance of TLSs significantly correlated with prognosis and provided a useful immune classification for iCCA. T follicular helper and regulatory T cells were identified as critical factors in determining the functional orientation of spatially different TLSs.
JOURNAL OF HEPATOLOGY
(2022)
Article
Oncology
Li Chu, Shuai Liu, Tiantian Guo, Liqing Zou, Bin Li, Jianjiao Ni, Xi Yang, Xiao Chu, Fei Liang, Yida Li, Yuyun Sun, Qiao Li, Fang Yin, Guodong Li, Zhengfei Zhu
Summary: In this study, the diagnostic performance of PET/CT and contrast-enhanced CT in detecting hilar lymph node metastasis in ESCC patients was evaluated. The results showed that both methods have limited value in guiding staging and radiotherapy planning due to their low positive predictive value.
FRONTIERS IN ONCOLOGY
(2022)
Article
Oncology
Xiaobin Shang, Wencheng Zhang, Gang Zhao, Fei Liang, Chen Zhang, Jie Yue, Xiaofeng Duan, Zhao Ma, Chuangui Chen, Qingsong Pang, Weihong Zhang, Liang Liu, Xiubao Ren, Bin Meng, Peng Zhang, Yegang Ma, Lin Zhang, Hecheng Li, Xiaozheng Kang, Yin Li, Hongjing Jiang
Summary: This study aims to compare the efficacy and safety of pembrolizumab combined with neoadjuvant chemotherapy and chemoradiotherapy versus neoadjuvant chemotherapy and chemoradiotherapy alone for locally advanced resectable esophageal squamous cell carcinoma.
FRONTIERS IN ONCOLOGY
(2022)
Article
Oncology
Xiaobin Shang, Gang Zhao, Fei Liang, Chen Zhang, Weihong Zhang, Liang Liu, Runmei Li, Xiaofeng Duan, Zhao Ma, Jie Yue, Chuangui Chen, Bin Meng, Xiubao Ren, Hongjing Jiang
Summary: This study aims to evaluate the safety and efficacy of pembrolizumab combined with TP as neoadjuvant therapy for locally advanced ESCC. The results will provide preliminary evidence of the efficacy of this novel treatment approach.
ANNALS OF TRANSLATIONAL MEDICINE
(2022)
Article
Oncology
Qingyang Feng, Wentao Tang, Zhiyuan Zhang, Ye Wei, Li Ren, Wenju Chang, Dexiang Zhu, Fei Liang, Guodong He, Jianmin Xu
Summary: Robotic surgery for rectal cancer significantly reduces surgical trauma and promotes postoperative recovery compared to laparoscopic surgery.
JOURNAL OF SURGICAL ONCOLOGY
(2022)
Article
Pediatrics
Wen-Xin Ge, Di Han, Zi-Yao Ding, Li-Ping Yi, Zhuo-Qiao Yang, Xin-Nan Wang, Yue Xiao, Fei Liang, Bo Hai, Hui-Ling Lv, Hui Shen, Hai-Bing Yang, Jie-Yun Yin, Jia Hu
Summary: This study aims to identify sex-specific BMI trajectories in children and assess their associations with hypertension. The study found four different BMI trajectories and highlighted the adverse effects of stable high BMI on hypertension, emphasizing the benefits of maintaining normal weight for children's health.
WORLD JOURNAL OF PEDIATRICS
(2023)
Article
Gastroenterology & Hepatology
Qingyang Feng, Weitang Yuan, Taiyuan Li, Bo Tang, Baoqing Jia, Yanbing Zhou, Wei Zhang, Ren Zhao, Cheng Zhang, Longwei Cheng, Xiaoqiao Zhang, Fei Liang, Guodong He, Ye Wei, Jianmin Xu
Summary: Robotic surgery for rectal cancer showed better oncological quality of resection, less surgical trauma, and better postoperative recovery compared to conventional laparoscopic surgery in patients with middle and low rectal cancer.
LANCET GASTROENTEROLOGY & HEPATOLOGY
(2022)
Article
Oncology
Fei Liang, Ling Peng, Zhengyu Wu, Georgios Giamas, Justin Stebbing
Summary: Although the use of prospective biomarker validation in phase III trials has increased in the past decade, issues such as undisclosed changes in trial design after commencement, inadequate reporting of results in biomarker-negative groups, and recommending treatment in biomarker-negative groups despite modest effects require significant improvement.
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE
(2023)
Review
Oncology
Yajing Wu, Vivek Verma, Carl M. Gay, Yujia Chen, Fei Liang, Qiang Lin, Jianing Wang, Wei Zhang, Zhouguang Hui, Min Zhao, Jun Wang, Joe Y. Chang
Summary: This systematic review and meta-analysis of 66 studies found that neoadjuvant immunotherapy is safe and efficacious for advanced resectable non-small cell lung cancer. Compared with chemotherapy alone, chemoimmunotherapy improved pathologic response rates and survival, particularly for patients with tumors expressing programmed cell death ligand-1, without increasing toxicities.
Letter
Oncology
Ling Peng, Justin Stebbing, Fei Liang, Yang Xia
TRANSLATIONAL LUNG CANCER RESEARCH
(2021)
