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Clinical trial end point and surrogate

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https://www.readbyqxmd.com/read/29759154/mrd-testing-in-multiple-myeloma-the-main-future-driver-for-modern-tailored-treatment
#1
REVIEW
Ola Landgren, Sydney X Lu, Malin Hultcrantz
The past decade, several highly efficacious drugs have been approved for the treatment of multiple myeloma. Many of these newer drugs are less toxic than older chemotherapy drugs. Using modern combination therapy in newly diagnosed multiple myeloma patients, high proportions of newly diagnosed multiple myeloma patients obtain minimal residual disease (MRD) negativity and MRD testing has rapidly become an integral part of clinical trials focusing on patients in this setting. Only recently, MRD negativity was reported in clinical trials focusing on older newly diagnosed multiple myeloma patients (ie, nontransplant candidates), as well as studies focusing on patients with relapsed or refractory multiple myeloma...
January 2018: Seminars in Hematology
https://www.readbyqxmd.com/read/29579423/modalities-to-monitor-the-treatment-response-in-tuberculosis
#2
REVIEW
Ujjwala N Gaikwad, Nitin R Gaikwad
Considering the global epidemic of drug resistance in Mycobacterium tuberculosis, early and accurate diagnosis as well as prompt initiation of antitubercular therapy (ATT) forms the mainstay of tuberculosis control programs. Patients on ATT may develop treatment failure due to diverse reasons including emergence of drug resistance in the host during the course of therapy. Monitoring the timely response to treatment in such cases has a significant role in rapid identification of drug resistant strains and institution of change of regimen to further decrease the morbidity and mortality associated with the disease...
April 2018: Indian Journal of Tuberculosis
https://www.readbyqxmd.com/read/29567657/factors-influencing-confidence-in-diagnostic-ratings-and-retreatment-recommendations-in-coiled-aneurysms
#3
M Ernst, L Kriston, M Groth, A M Frölich, J Fiehler, J-H Buhk
BACKGROUND AND PURPOSE: Angiographic occlusion and retreatment of coiled aneurysms are commonly used as surrogate end points in clinical trials. We aimed to evaluate the influence of aneurysm, patient, and rater characteristics on the confidence of visual evaluation of aneurysm coiling and retreatment decisions. MATERIALS AND METHODS: Twenty-six participants of the Advanced Course in Endovascular Interventional Neuroradiology of the European Society of Neuroradiology were asked to evaluate digital subtraction angiography examinations of patients who had undergone endovascular coiling, by determining the grade of aneurysm occlusion, the change between immediate postprocedural and follow-up angiograms, their level of confidence, the technical difficulty of retreatment, and the best therapeutic approach...
March 22, 2018: AJNR. American Journal of Neuroradiology
https://www.readbyqxmd.com/read/29520581/biomarkers-of-diabetic-kidney-disease
#4
REVIEW
Helen M Colhoun, M Loredana Marcovecchio
Diabetic kidney disease (DKD) remains one of the leading causes of reduced lifespan in diabetes. The quest for both prognostic and surrogate endpoint biomarkers for advanced DKD and end-stage renal disease has received major investment and interest in recent years. However, at present no novel biomarkers are in routine use in the clinic or in trials. This review focuses on the current status of prognostic biomarkers. First, we emphasise that albuminuria and eGFR, with other routine clinical data, show at least modest prediction of future renal status if properly used...
May 2018: Diabetologia
https://www.readbyqxmd.com/read/29516749/beyond-jak-2-potential-targets-for-myeloproliferative-neoplasm-therapy
#5
Patrick M Harrington, Claire N Harrison
The outlook for patients with myeloproliferative neoplasms, particularly myelofibrosis, has improved in recent years, with greater understanding of the pathogenesis and the subsequent development of a plethora of new agents. Areas covered: This article will discuss some of the advances in the field in recent years and explore in greater detail some of the most advanced emerging agents as well as those with greatest potential. An extensive literature review has been performed to identify recent clinical trials and any relevant pre-clinical work...
April 2018: Expert Review of Hematology
https://www.readbyqxmd.com/read/29470579/defining-the-most-appropriate-primary-end-point-in-phase-2-trials-of-immune-checkpoint-inhibitors-for-advanced-solid-cancers-a-systematic-review-and-meta-analysis
#6
Georgia Ritchie, Harry Gasper, Johnathan Man, Sally Lord, Ian Marschner, Michael Friedlander, Chee Khoon Lee
Importance: Checkpoint inhibitors have a unique mechanism of action that differs from chemotherapy or targeted therapies. The validity of objective response rate (ORR) as a surrogate for progression-free survival (PFS) and overall survival (OS) in checkpoint-inhibitor trials is uncertain. Objective: To determine the types of primary end points used in phase 2 checkpoint-inhibitor trials, and to assess the strength of associations for ORR with PFS and OS. Data Sources: Trials listed in electronic databases from 2000 to 2017 (PREMEDLINE, MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials)...
April 1, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29449411/molecular-imaging-in-drug-discovery-and-development
#7
Jonathan R Lindner, Jeanne Link
Noninvasive imaging has played an increasing role in the process of cardiovascular drug development. This review focuses specifically on the use of molecular imaging, which has been increasingly applied to improve and accelerate certain preclinical steps in drug development, including the identification of appropriate therapeutic targets, evaluation of on-target and off-target effects of candidate therapies, assessment of dose response, and the evaluation of drug or biological biodistribution and pharmacodynamics...
February 2018: Circulation. Cardiovascular Imaging
https://www.readbyqxmd.com/read/29440923/managing-hyperparathyroidism-in-hemodialysis-role-of-etelcalcetide
#8
REVIEW
Keith E Eidman, James B Wetmore
Secondary hyperparathyroidism (SHPT) is common in patients receiving maintenance hemodialysis and is associated with adverse outcomes. Currently, SHPT is managed by reducing circulating levels of phosphate with oral binders and parathyroid hormone (PTH) with vitamin D analogs and/or the calcimimetic cinacalcet. Etelcalcetide, a novel calcimimetic administered intravenously (IV) at the end of a hemodialysis treatment session, effectively reduces PTH in clinical trials when given thrice weekly. Additional clinical effects include reductions in circulating levels of phosphate and FGF-23 and an improved profile of markers of bone turnover...
2018: International Journal of Nephrology and Renovascular Disease
https://www.readbyqxmd.com/read/29409850/efficacy-and-safety-of-pueraria-candollei-var-mirifica-airy-shaw-suvat-niyomdham-for-menopausal-women-a-systematic-review-of-clinical-trials-and-the-way-forward
#9
Chuenjid Kongkaew, Norman C Scholfield, Teerapon Dhippayom, Piyameth Dilokthornsakul, Surasak Saokaew, Nathorn Chaiyakunapruk
ETHNOPHARMACOLOGICAL RELEVANCE: Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham (commonly termed P. mirifica, PM) growing in upland Thailand has a long history as a postmenopausal rejuvenant therapy for indigenants. Its amelioration of menopause symptoms in clinical trials was assessed. MATERIALS AND METHODS: International and Thai databases were searched from inception to February 2017. Clinical trials investigating effects of PM menopausal or postmenopausal women were included...
April 24, 2018: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/29310183/re-surrogate-end-points-for-all-cause-mortality-in-men-with-localized-unfavorable-risk-prostate-cancer-treated-with-radiation-therapy-vs-radiation-therapy-plus-androgen-deprivation-therapy-a-secondary-analysis-of-a-randomized-clinical-trial
#10
https://www.readbyqxmd.com/read/29260622/surrogate-end-points-for-overall-survival-in-trials-of-pd-l-1-inhibitors-for-urinary-cancers-a-systematic-review
#11
Omar Abdel-Rahman
AIM: Numerous trials for PD-(L)1 inhibitors in the management of advanced urinary cancers (urothelial carcinoma and renal cell carcinoma) were published recently. It is not known exactly what should be the optimal surrogate end point for overall survival (OS) in this context. MATERIALS & METHODS: PubMed database and ASCO meeting library were searched till August 2017. Eligible studies included prospective clinical studies evaluating PD-(L)1 inhibitors for the management of advanced urothelial carcinoma or renal cell carcinoma...
February 2018: Immunotherapy
https://www.readbyqxmd.com/read/29055841/response-rate-as-a-potential-surrogate-for-survival-and-efficacy-in-patients-treated-with-novel-immune-checkpoint-inhibitors-a-meta-regression-of-randomised-prospective-studies
#12
REVIEW
Giandomenico Roviello, Fabrice Andre, Sergio Venturini, Barbara Pistilli, Giuseppe Curigliano, Massimo Cristofanilli, Pietro Rosellini, Daniele Generali
INTRODUCTION: To assess the role of the tumour response rate (RR) after immune checkpoint inhibitors-based therapy as a potential surrogate end-point of progression-free survival (PFS) and overall survival (OS) in patients with solid tumours, we performed a trial-based meta-regression of randomised studies comparing different immune checkpoint inhibitors-based treatments. METHODS: The systematic literature search included the electronic databases and the proceedings of oncologic meetings...
November 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/29020339/use-of-viral-load-as-a-surrogate-marker-in-clinical-studies-of-cytomegalovirus-in-solid-organ-transplantation-a-systematic-review-and-meta-analysis
#13
Yoichiro Natori, Ali Alghamdi, Mahmood Tazari, Veronica Miller, Shahid Husain, Takashi Komatsu, Paul Griffiths, Per Ljungman, Ani Orchanian-Cheff, Deepali Kumar, Atul Humar
Symptomatic cytomegalovirus (CMV) disease has been the standard endpoint for clinical trials in organ transplant recipients. Viral load may be a more relevant endpoint due to low frequency of disease. We performed a meta-analysis and systematic review of the literature. We found several lines of evidence to support the validity of viral load as an appropriate surrogate end-point, including the following: (1) viral loads in CMV disease are significantly greater than in asymptomatic viremia (odds ratio, 9.3 95% confidence interval, 4...
February 1, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29020259/report-of-an-esc-eapci-task-force-on-the-evaluation-and-use-of-bioresorbable-scaffolds-for-percutaneous-coronary-intervention-executive-summary
#14
Robert A Byrne, Giulio G Stefanini, Davide Capodanno, Yoshinobu Onuma, Andreas Baumbach, Javier Escaned, Michael Haude, Stefan James, Michael Joner, Peter Jüni, Adnan Kastrati, Semih Oktay, William Wijns, Patrick W Serruys, Stephan Windecker
A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device-the Absorb bioresorbable vascular scaffold-has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years...
August 28, 2017: European Heart Journal
https://www.readbyqxmd.com/read/29019452/minimal-residual-disease-analysis-in-myeloma-when-why-and-where
#15
Uday Yanamandra, Shaji K Kumar
The primary hurdle in the path to curing multiple myeloma (MM) is defining a validated minimal residual disease (MRD) and its utility in the therapeutic decision making. A better definition of MRD will aid in tailoring MM therapy further to address the clonal heterogeneity and genomic instability and overcome patient's ineffective immune surveillance. MRD analysis can define the logical endpoint for maintenance therapy, in addition also aids in providing a better clinical end point for studies comparing novel agents in myeloma...
October 11, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28948934/report-of-an-esc-eapci-task-force-on-the-evaluation-and-use-of-bioresorbable-scaffolds-for-percutaneous-coronary-intervention-executive-summary
#16
Robert A Byrne, Giulio G Stefanini, Davide Capodanno, Yoshinobu Onuma, Andreas Baumbach, Javier Escaned, Michael Haude, Stefan James, Michael Joner, Peter Jüni, Adnan Kastrati, Semih Oktay, William Wijns, Patrick W Serruys, Stephan Windecker
A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device -the Absorb bioresorbable vascular scaffold- has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years...
January 20, 2018: EuroIntervention
https://www.readbyqxmd.com/read/28889347/decline-in-estimated-glomerular-filtration-rate-is-associated-with-risk-of-end-stage-renal-disease-in-type-2-diabetes-with-macroalbuminuria-an-observational-study-from-jdncs
#17
Miho Shimizu, Kengo Furuichi, Tadashi Toyama, Tomoaki Funamoto, Shinji Kitajima, Akinori Hara, Daisuke Ogawa, Daisuke Koya, Kenzo Ikeda, Yoshitaka Koshino, Yukie Kurokawa, Hideharu Abe, Kiyoshi Mori, Masaaki Nakayama, Yoshio Konishi, Ken-Ichi Samejima, Masaru Matsui, Hiroyuki Yamauchi, Tomohito Gohda, Kei Fukami, Daisuke Nagata, Hidenori Yamazaki, Yukio Yuzawa, Yoshiki Suzuki, Shouichi Fujimoto, Shoichi Maruyama, Sawako Kato, Takero Naito, Kenichi Yoshimura, Hitoshi Yokoyama, Takashi Wada
BACKGROUND: There is increased interest in surrogate endpoints for clinical trials of chronic kidney disease. METHODS: In this nationwide observational study of 456 patients with type 2 diabetes and clinically suspected diabetic nephropathy followed for a median of 4.2 years, we evaluated the association between estimated glomerular filtration rate (eGFR) and albuminuria at baseline or during follow-up and risk of ESRD. RESULTS: Low eGFR (<60 mL/min/1...
April 2018: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28818493/progression-free-survival-and-time-to-progression-as-real-surrogate-end-points-for-overall-survival-in-advanced-breast-cancer-a-meta-analysis-of-37-trials
#18
Ling Li, Zhanyu Pan
BACKGROUND: Progression-free survival (PFS) and time to progression (TTP) have been reported to correlate with overall survival (OS) in several cancer types. To our knowledge, however, the correlation between them is unclear. METHODS: A literature-based meta-analysis was performed to assess whether PFS and TTP can be considered reliable surrogate end points for OS in a phase 3 clinical trial of advanced breast cancer (ABC). The median hazard ratios of PFS/TTP and OS were analyzed by determining their nonparametric Spearman rank correlation coefficients (Rs)...
February 2018: Clinical Breast Cancer
https://www.readbyqxmd.com/read/28810023/characteristics-of-preapproval-and-postapproval-studies-for-drugs-granted-accelerated-approval-by-the-us-food-and-drug-administration
#19
Huseyin Naci, Katelyn R Smalley, Aaron S Kesselheim
Importance: Drugs treating serious or life-threatening conditions can receive US Food and Drug Administration (FDA) accelerated approval based on showing an effect in surrogate measures that are only reasonably likely to predict clinical benefit. Confirmatory trials are then required to determine whether these effects translate to clinical improvements. Objective: To characterize preapproval and confirmatory clinical trials of drugs granted accelerated approval...
August 15, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28810022/characteristics-of-clinical-studies-used-for-us-food-and-drug-administration-approval-of-high-risk-medical-device-supplements
#20
Sarah Y Zheng, Sanket S Dhruva, Rita F Redberg
Importance: High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. Objective: To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data)...
August 15, 2017: JAMA: the Journal of the American Medical Association
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