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Clinical trial end point and surrogate

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https://www.readbyqxmd.com/read/28292495/time-to-review-the-role-of-surrogate-end-points-in-health-policy-state-of-the-art-and-the-way-forward
#1
Oriana Ciani, Marc Buyse, Michael Drummond, Guido Rasi, Everardo D Saad, Rod S Taylor
The efficacy of medicines, medical devices, and other health technologies should be proved in trials that assess final patient-relevant outcomes such as survival or morbidity. Market access and coverage decisions are, however, often based on surrogate end points, biomarkers, or intermediate end points, which aim to substitute and predict patient-relevant outcomes that are unavailable because of methodological, financial, or practical constraints. We provide a summary of the present use of surrogate end points in health care policy, discussing the case for and against their adoption and reviewing validation methods...
March 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28262586/surrogate-end-points-for-overall-survival-in-22-neoadjuvant-trials-of-gastro-oesophageal-cancers
#2
Fausto Petrelli, Gianluca Tomasello, Sandro Barni
BACKGROUND: The surrogacy between disease-free survival (DFS) and overall survival (OS) has been evaluated in patients with gastric cancer who received adjuvant chemotherapy. Similar analyses in patients who have undergone neoadjuvant chemoradiotherapy (CTRT) or chemotherapy (CT) for gastro-oesophageal (GE) cancer have not yet been performed. METHODS: We evaluated the correlation between DFS and pathologic complete response (pCR) with OS in patients with GE carcinomas enrolled in randomised studies...
March 2, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28244858/the-assessment-and-appraisal-of-regenerative-medicines-and-cell-therapy-products-an-exploration-of-methods-for-review-economic-evaluation-and-appraisal
#3
Robert Hettle, Mark Corbett, Sebastian Hinde, Robert Hodgson, Julie Jones-Diette, Nerys Woolacott, Stephen Palmer
BACKGROUND: The National Institute for Health and Care Excellence (NICE) commissioned a 'mock technology appraisal' to assess whether changes to its methods and processes are needed. This report presents the findings of independent research commissioned to inform this appraisal and the deliberations of a panel convened by NICE to evaluate the mock appraisal. METHODS: Our research included reviews to identify issues, analysis methods and conceptual differences and the relevance of alternative decision frameworks, alongside the development of an exemplar case study of chimeric antigen receptor (CAR) T-cell therapy for treating acute lymphoblastic leukaemia...
February 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28229054/effectiveness-of-vitamin-d-supplementation-for-cardiovascular-health-outcomes
#4
REVIEW
Panagiota Veloudi, Graeme Jones, James E Sharman
There is a plausible physiological theory, supported by many observational studies, that vitamin D supplementation should be effective for improving cardiovascular end points, such as blood pressure (BP), large artery stiffness, atherosclerosis, endothelial function and clinical events. However, results from randomised controlled trials (RCTs) have been inconsistent. In this review, we evaluated the evidence regarding the effectiveness of vitamin D supplementation for cardiovascular surrogate and hard clinical end points...
January 2017: Pulse (Basel, Switzerland)
https://www.readbyqxmd.com/read/28220472/renal-denervation-for-resistant-hypertension
#5
REVIEW
Giuseppe Coppolino, Anna Pisano, Laura Rivoli, Davide Bolignano
BACKGROUND: Resistant hypertension is highly prevalent among the general hypertensive population and the clinical management of this condition remains problematic. Different approaches, including a more intensified antihypertensive therapy, lifestyle modifications, or both, have largely failed to improve patients' outcomes and to reduce cardiovascular and renal risk. As renal sympathetic hyperactivity is a major driver of resistant hypertension, renal sympathetic ablation (renal denervation) has been recently proposed as a possible therapeutic alternative to treat this condition...
February 21, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28205262/modern-multiple-myeloma-therapy-deep-sustained-treatment-response-and-good-clinical-outcomes
#6
REVIEW
O Landgren, K Iskander
In the USA at the beginning of this century, the average overall survival in patients with multiple myeloma was about 3 years. Around that time, three drugs (bortezomib, lenalidomide and thalidomide) were introduced for the treatment of multiple myeloma and, in 2012, carfilzomib received accelerated approval by the US Food and Drug Administration (FDA). Driven by access to better drugs, median overall survival in younger patients (aged <50 years) was >10 years by 2014. The FDA approved 14 new drugs for the treatment of cancer in 2015; four of these were approved for the treatment of myeloma (panobinostat, daratumumab, elotuzumab and ixazomib)...
February 16, 2017: Journal of Internal Medicine
https://www.readbyqxmd.com/read/28191271/the-unchartered-frontier-preventive-cardiology-between-the-ages-of-15-and-35-years
#7
Holly Gooding, Heather M Johnson
It is well established that atherosclerosis, the pathological basis of cardiovascular disease (CVD), begins in childhood and progresses steadily between the ages of 15 to 35 years. These adolescent and young adult years are also marked by significant physiological, psychological, and sociodemographic changes that impact both CVD risk factor development and CVD prevention and treatment strategies. In this review, we highlight the importance of the primordial prevention of CVD risk factors before they ever occur and the primary prevention of CVD by treating CVD risk factors in this age group...
September 2016: Current Cardiovascular Risk Reports
https://www.readbyqxmd.com/read/28188612/hepatitis-b-immunoglobulin-during-pregnancy-for-prevention-of-mother-to-child-transmission-of-hepatitis-b-virus
#8
REVIEW
Ahizechukwu C Eke, George U Eleje, Uzoamaka A Eke, Yun Xia, Jiao Liu
BACKGROUND: Hepatitis is a viral infection of the liver. It is mainly transmitted between people through contact with infected blood, frequently from mother to baby in-utero. Hepatitis B poses significant risk to the fetus and up to 85% of infants infected by their mothers at birth develop chronic hepatitis B virus (HBV) infection. Hepatitis B immunoglobulin (HBIG) is a purified solution of human immunoglobulin that could be administered to the mother, newborn, or both. HBIG offers protection against HBV infection when administered to pregnant women who test positive for hepatitis B envelope antigen (HBeAg) or hepatitis B surface antigen (HBsAg), or both...
February 11, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28115079/use-of-surrogate-outcomes-in-nephrology-research
#9
REVIEW
Joshua Samuels
Clinical trials are large and expensive and could require exceedingly long-term follow-up for subjects to reach clinically meaningful end points. To combat these methodologic issues, researchers sometimes use biomarkers as surrogate end points. A biomarker is an objectively measured characteristic that is indicative of some underlying phenomenon or process, while a surrogate is a biomarker that "takes the place" of a clinically meaningful outcome, usually earlier in the disease process. This paper reviews the history, strengths, and weaknesses of surrogate outcome use in clinical research and then discusses potential surrogate outcomes in nephrology research...
November 2016: Advances in Chronic Kidney Disease
https://www.readbyqxmd.com/read/28099439/single-versus-serial-measurements-of-neuron-specific-enolase-and-prediction-of-poor-neurological-outcome-in-persistently-unconscious-patients-after-out-of-hospital-cardiac-arrest-a-ttm-trial-substudy
#10
Sebastian Wiberg, Christian Hassager, Pascal Stammet, Matilde Winther-Jensen, Jakob Hartvig Thomsen, David Erlinge, Michael Wanscher, Niklas Nielsen, Tommaso Pellis, Anders Åneman, Hans Friberg, Jan Hovdenes, Janneke Horn, Jørn Wetterslev, John Bro-Jeppesen, Matthew P Wise, Michael Kuiper, Tobias Cronberg, Yvan Gasche, Yvan Devaux, Jesper Kjaergaard
BACKGROUND: Prediction of neurological outcome is a crucial part of post cardiac arrest care and prediction in patients remaining unconscious and/or sedated after rewarming from targeted temperature management (TTM) remains difficult. Current guidelines suggest the use of serial measurements of the biomarker neuron-specific enolase (NSE) in combination with other predictors of outcome in patients admitted after out-of-hospital cardiac arrest (OHCA). This study sought to investigate the ability of NSE to predict poor outcome in patients remaining unconscious at day three after OHCA...
2017: PloS One
https://www.readbyqxmd.com/read/28097317/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
#11
Trevor J Royce, Ming-Hui Chen, Jing Wu, Marian Loffredo, Andrew A Renshaw, Philip W Kantoff, Anthony V D'Amico
Importance: Several surrogates for prostate cancer-specific mortality satisfying the Prentice criteria exist, but whether these are surrogates for all-cause mortality, and how their performance compares, is unknown. Objective: To ascertain and compare the performance of 4 candidate surrogates (prostate-specific antigen [PSA] failure, PSA nadir >0.5 ng/mL, PSA doubling time <9 months, and interval to PSA failure <30 months) for all-cause mortality using the proportion of treatment-effect metric...
January 12, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28095160/minimal-loss-of-lifetime-for-patients-with-diffuse-large-b-cell-lymphoma-in-remission-and-event-free-24-months-after-treatment-a-danish-population-based-study
#12
Lasse Hjort Jakobsen, Martin Bøgsted, Peter de Nully Brown, Bente Arboe, Judit Jørgensen, Thomas Stauffer Larsen, Maja Bech Juul, Lene Schurmann, Linda Højberg, Olav Jonas Bergmann, Therese Lassen, Pär Lars Josefsson, Paw Jensen, Hans Erik Johnsen, Tarec Christoffer El-Galaly
Purpose The general outlook for patients with diffuse large B-cell lymphoma (DLBCL) in first remission is important information for patients and for planning post-treatment follow-up. The purpose of this study was to evaluate the survival of patients with DLBCL in remission compared with a matched general population. Methods A total of 1,621 patients from the Danish Lymphoma Registry who were newly diagnosed with DLBCL between 2003 and 2011 were included in this study. All patients were ≥ 16 years of age at diagnosis and had achieved complete remission or complete remission unconfirmed after first-line rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or R-CHOP-like therapy...
March 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28061544/findings-from-the-adjuvant-colon-cancer-end-points-accent-collaborative-group-the-power-of-pooled-individual-patient-data-from-multiple-clinical-trials
#13
Lindsay A Renfro, Daniel J Sargent
The Adjuvant Colon Cancer End Points (ACCENT) Collaborative Group was formed 15 years ago to address scientific questions in early stage colon cancer that could best be answered by pooling individual patient data across many randomized clinical trials. Today, the ACCENT database contains detailed information collected from over 40,000 patients enrolled onto 27 major adjuvant colon cancer trials conducted between 1977 and 2009. Since its inception, the ACCENT group has led many sophisticated analyses addressing a variety of clinical questions, such as the long-term survivorship of colon cancer patients by treatment, the time course of oxaliplatin benefit, and support for the use of disease-free survival (DFS) as a surrogate endpoint for overall survival (OS), among many others...
December 2016: Chinese Clinical Oncology
https://www.readbyqxmd.com/read/28029309/thirty-month-complete-response-as-a-surrogate-end-point-in-first-line-follicular-lymphoma-therapy-an-individual-patient-level-analysis-of-multiple-randomized-trials
#14
Qian Shi, Christopher R Flowers, Wolfgang Hiddemann, Robert Marcus, Michael Herold, Anton Hagenbeek, Eva Kimby, Howard Hochster, Umberto Vitolo, Bruce A Peterson, Emmanuel Gyan, Michele Ghielmini, Tina Nielsen, Sabine De Bedout, Tommy Fu, Nancy Valente, Nathan H Fowler, Eva Hoster, Marco Ladetto, Franck Morschhauser, Emanuele Zucca, Gilles Salles, Daniel J Sargent
Purpose Follicular lymphoma (FL) is an indolent cancer, with effective but rarely curative treatment options. As a standard study end point for first-line FL therapy, progression-free survival (PFS) requires extended follow-up (median PFS, > 7 years). To provide patients with earlier access to newer therapies, an earlier end point to expedite clinical trials is needed. Our objective was to formally assess the complete response rate at 30 months (CR30) after initiation of induction therapy as a potential surrogate end point for PFS in first-line FL therapy...
December 28, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28003879/should-hydrogen-therapy-be-included-in-a-musculoskeletal-medicine-routine
#15
Sergej M Ostojic
Molecular hydrogen (H 2) has recently been recognized as a potential novel therapeutic agent in biomedicine. Initially proposed to be a possible treatment for certain types of neuromuscular disorders, cardio-metabolic diseases and cancer, H 2 improved clinical end-points and surrogate markers in several clinical trials, mainly acting as an anti-inflammatory agent and powerful antioxidant. In this paper, the medicinal properties of H 2 in musculoskeletal medicine are discussed with the aim to provide an updated and practical overview for health professionals working in this field...
2016: F1000Research
https://www.readbyqxmd.com/read/27998881/cholesterol-paradox-a-correlate-does-not-a-surrogate-make
#16
Robert DuBroff
The global campaign to lower cholesterol by diet and drugs has failed to thwart the developing pandemic of coronary heart disease around the world. Some experts believe this failure is due to the explosive rise in obesity and diabetes, but it is equally plausible that the cholesterol hypothesis, which posits that lowering cholesterol prevents cardiovascular disease, is incorrect. The recently presented ACCELERATE trial dumbfounded many experts by failing to demonstrate any cardiovascular benefit of evacetrapib despite dramatically lowering low-density lipoprotein cholesterol and raising high-density lipoprotein cholesterol in high-risk patients with coronary disease...
March 2017: Evidence-based Medicine
https://www.readbyqxmd.com/read/27979038/baseline-assessment-and-comparison-of-arterial-anatomy-hyperemic-flow-and-skeletal-muscle-perfusion-in-peripheral-artery-disease-the-cardiovascular-cell-therapy-research-network-patients-with-intermittent-claudication-injected-with-aldh-bright-cells-cctrn-pace
#17
Bharath Ambale Venkatesh, Victor Nauffal, Chikara Noda, Tomoki Fujii, Phillip C Yang, Judy Bettencourt, Erin P Ricketts, Michael Murphy, Nicholas J Leeper, Lem Moyé, Ray F Ebert, Raja Muthupillai, David A Bluemke, Emerson C Perin, Alan T Hirsch, João A C Lima
BACKGROUND: Peripheral artery disease (PAD) is important to public health as a major contributor to cardiovascular morbidity and mortality. Recent developments in magnetic resonance imaging (MRI) techniques permit improved assessment of PAD anatomy and physiology, and may serve as surrogate end points after proangiogenic therapies. METHODS: The PACE study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the physiologic impact and potential clinical efficacy of autologous bone marrow-derived ALDH(br) stem cells...
January 2017: American Heart Journal
https://www.readbyqxmd.com/read/27913502/mrd-in-aml-does-it-already-guide-therapy-decision-making
#18
Gert Ossenkoppele, Gerrit Jan Schuurhuis
Prognostic factors determined at diagnosis are predictive for outcome whereas achievement of morphological complete remission (CR) is still an important end point during treatment. Residual disease after therapy may reflect the sum of all diagnosis and postdiagnosis resistance mechanisms/factors; its measurement could hypothetically be very instrumental for guiding treatment. The possibility of defining residual disease (minimal residual disease [MRD]) far below the level of 5% blast cells is changing the landscape of risk classification...
December 2, 2016: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/27913493/novel-agents-in-follicular-lymphoma-choosing-the-best-target
#19
Laurie H Sehn
Outcomes in patients with follicular lymphoma (FL) have improved dramatically over the last decade. However, novel agents are greatly needed for those who exhibit treatment resistance, in order to minimize lifelong toxicity and to enable combinations that may allow us to achieve the elusive goal of cure. Biological advances have led to the discovery of a large number of potential therapeutic targets and the development of a plethora of novel agents designed to exploit these processes. Possible targets include tumor cell surface markers, key components of intracellular pathways and epigenetic mechanisms, and reactive cells of the microenvironment...
December 2, 2016: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/27900954/renin-angiotensin-aldosterone-system-blockade-in-diabetic-kidney-disease-a-critical-and-contrarian-point-of-view
#20
REVIEW
Mohamed E Elrggal, Shaaban M S Ahmed, Meguid El Nahas
Diabetes mellitus is the most common cause of end-stage renal disease (ESRD) worldwide. Diabetic kidney disease (DKD) is associated with high morbidity and cardiovascular mortality. A number of guidelines and recommendations have been issued over the years recommending the use of renin-angiotensin-aldosterone system (RAAS) blockade in the management of DKD. This critical analysis takes a contrarian view, based on a selection of key clinical trials in the field, to argue that albuminuria should not be considered a target for treatment but instead a surrogate marker of DKD progression...
November 2016: Saudi Journal of Kidney Diseases and Transplantation
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