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adaptive clinical trials

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https://www.readbyqxmd.com/read/29036837/simvastatin-as-a-potential-disease-modifying-therapy-for-patients-with-parkinson-s-disease-rationale-for%C3%A2-clinical-trial-and-current-progress
#1
Camille B Carroll, Richard K H Wyse
Many now believe the holy grail for the next stage of therapeutic advance surrounds the development of disease-modifying approaches aimed at intercepting the year-on-year neurodegenerative decline experienced by most patients with Parkinson's disease (PD). Based on recommendations of an international committee of experts who are currently bringing multiple, potentially disease-modifying, PD therapeutics into long-term neuroprotective PD trials, a clinical trial involving 198 patients is underway to determine whether Simvastatin provides protection against chronic neurodegeneration...
October 13, 2017: Journal of Parkinson's Disease
https://www.readbyqxmd.com/read/29036330/adding-experimental-arms-to-platform-clinical-trials-randomization-procedures-and-interim-analyses
#2
Steffen Ventz, Matteo Cellamare, Giovanni Parmigiani, Lorenzo Trippa
Multi-arm clinical trials use a single control arm to evaluate multiple experimental treatments. In most cases this feature makes multi-arm studies considerably more efficient than two-arm studies. A bottleneck for implementation of a multi-arm trial is the requirement that all experimental treatments have to be available at the enrollment of the first patient. New drugs are rarely at the same stage of development. These limitations motivate our study of statistical methods for adding new experimental arms after a clinical trial has started enrolling patients...
July 17, 2017: Biostatistics
https://www.readbyqxmd.com/read/29031778/extended-adjuvant-aromatase-inhibition-after-sequential-endocrine-therapy-data-a-randomised-phase-3-trial
#3
Vivianne C G Tjan-Heijnen, Irene E G van Hellemond, Petronella G M Peer, Astrid C P Swinkels, Carolien H Smorenburg, Maurice J C van der Sangen, Judith R Kroep, Hiltje De Graaf, Aafke H Honkoop, Frans L G Erdkamp, Franchette W P J van den Berkmortel, Maaike de Boer, Wilfred K de Roos, Sabine C Linn, Alexander L T Imholz, Caroline M Seynaeve
BACKGROUND: The effect of extended adjuvant aromatase inhibition in hormone receptor-positive breast cancer after sequential endocrine therapy of tamoxifen followed by an aromatase inhibitor for a 5-year treatment period still needs clarification. To address this issue, we began the DATA study to assess different durations of anastrozole therapy after tamoxifen. METHODS: DATA was a prospective, randomised, open-label, multicentre, phase 3 study done in 79 hospitals in the Netherlands...
October 11, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29031740/eyetracking-metrics-reveal-impaired-spatial-anticipation-in-behavioural-variant-frontotemporal-dementia
#4
Silvia Primativo, Camilla Clark, Keir Xx Yong, Nicholas C Firth, Jennifer Nicholas, Daniel Alexander, Jason D Warren, Jonathan D Rohrer, Sebastian J Crutch
Eyetracking technology has had limited application in the dementia field to date, with most studies attempting to discriminate syndrome subgroups on the basis of basic oculomotor functions rather than higher-order cognitive abilities. Eyetracking-based tasks may also offer opportunities to reduce or ameliorate problems associated with standard paper-and-pencil cognitive tests such as the complexity and linguistic demands of verbal test instructions, and the problems of tiredness and attention associated with lengthy tasks that generate few data points at a slow rate...
October 11, 2017: Neuropsychologia
https://www.readbyqxmd.com/read/29030654/predictive-and-prognostic-value-of-tumor-volume-and-its-changes-during-radical-radiotherapy-of-stage%C3%A2-iii-non-small-cell-lung-cancer-a%C3%A2-systematic-review
#5
Lukas Käsmann, Maximilian Niyazi, Oliver Blanck, Christian Baues, René Baumann, Sophie Dobiasch, Chukwuka Eze, Daniel Fleischmann, Tobias Gauer, Frank A Giordano, Yvonne Goy, Jan Hausmann, Christoph Henkenberens, David Kaul, Lisa Klook, David Krug, Matthias Mäurer, Cédric M Panje, Johannes Rosenbrock, Lisa Sautter, Daniela Schmitt, Christoph Süß, Alexander H Thieme, Maike Trommer-Nestler, Sonia Ziegler, Nadja Ebert, Daniel Medenwald, Christian Ostheimer
PURPOSE: Lung cancer remains the leading cause of cancer-related mortality worldwide. Stage III non-small cell lung cancer (NSCLC) includes heterogeneous presentation of the disease including lymph node involvement and large tumour volumes with infiltration of the mediastinum, heart or spine. In the treatment of stage III NSCLC an interdisciplinary approach including radiotherapy is considered standard of care with acceptable toxicity and improved clinical outcome concerning local control...
October 13, 2017: Strahlentherapie und Onkologie: Organ der Deutschen Röntgengesellschaft ... [et Al]
https://www.readbyqxmd.com/read/29030383/12-week-24-7-ambulatory-artificial-pancreas-with-weekly-adaptation-of-insulin-delivery-settings-effect-on-hemoglobin-a1c-and-hypoglycemia
#6
Eyal Dassau, Jordan E Pinsker, Yogish C Kudva, Sue A Brown, Ravi Gondhalekar, Chiara Dalla Man, Steve Patek, Michele Schiavon, Vikash Dadlani, Isuru Dasanayake, Mei Mei Church, Rickey E Carter, Wendy C Bevier, Lauren M Huyett, Jonathan Hughes, Stacey Anderson, Dayu Lv, Elaine Schertz, Emma Emory, Shelly K McCrady-Spitzer, Tyler Jean, Paige K Bradley, Ling Hinshaw, Alejandro J Laguna Sanz, Ananda Basu, Boris Kovatchev, Claudio Cobelli, Francis J Doyle
OBJECTIVE: Artificial pancreas (AP) systems are best positioned for optimal treatment of type 1 diabetes (T1D) and are currently being tested in outpatient clinical trials. Our consortium developed and tested a novel adaptive AP in an outpatient, single-arm, uncontrolled multicenter clinical trial lasting 12 weeks. RESEARCH DESIGN AND METHODS: Thirty adults with T1D completed a continuous glucose monitor (CGM)-augmented 1-week sensor-augmented pump (SAP) period...
October 13, 2017: Diabetes Care
https://www.readbyqxmd.com/read/29028418/cancer-center-clinic-and-research-team-perceptions-of-identity-and-interactions
#7
Torsten Reimer, Simon J Craddock Lee, Sandra Garcia, Mary Gill, Tobi Duncan, Erin L Williams, David E Gerber
PURPOSE: Conduct of cancer clinical trials requires coordination and cooperation among research and clinic teams. Diffusion of and confusion about responsibility may occur if team members' perceptions of roles and objectives do not align. These factors are critical to the success of cancer centers but are poorly studied. METHODS: We developed a survey adapting components of the Adapted Team Climate Inventory, Measure of Team Identification, and Measure of In-Group Bias...
October 13, 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/29028178/zika-virus-immune-evasion-mechanisms-currently-available-therapeutic-regimens-and-vaccines
#8
Arun Asif, Sobia Manzoor, Fatima Tuz-Zahra, Muhammad Saalim, Maliha Ashraf, Javeria Ishtiyaq, Madiha Khalid
The sudden emergence of infectious pathogens such as Zika virus (ZIKV) holds global health concerns. Recent dissemination of ZIKV from Pacific to Americas with an upsurge of congenital anomalies and Guillain Barre Syndrome (GBS) in adults has created an alarming situation. High-throughput studies are in progress to understand ZIKV's mode of pathogenesis and mechanism of immune escape, yet the pathogenesis remains obscure. Mainly ZIKV's envelope (E) protein and nonstructural proteins (mainly NS1 and NS5) manipulate host cell to support viral immune escape by modulation of the interferon pathway and complement antagonism...
October 13, 2017: Viral Immunology
https://www.readbyqxmd.com/read/29025427/adaptive-hybrid-robotic-system-for-rehabilitation-of-reaching-movement-after-a-brain-injury-a-usability-study
#9
F Resquín, J Gonzalez-Vargas, J Ibáñez, F Brunetti, I Dimbwadyo, L Carrasco, S Alves, C Gonzalez-Alted, A Gomez-Blanco, J L Pons
BACKGROUND: Brain injury survivors often present upper-limb motor impairment affecting the execution of functional activities such as reaching. A currently active research line seeking to maximize upper-limb motor recovery after a brain injury, deals with the combined use of functional electrical stimulation (FES) and mechanical supporting devices, in what has been previously termed hybrid robotic systems. This study evaluates from the technical and clinical perspectives the usability of an integrated hybrid robotic system for the rehabilitation of upper-limb reaching movements after a brain lesion affecting the motor function...
October 12, 2017: Journal of Neuroengineering and Rehabilitation
https://www.readbyqxmd.com/read/29022264/experimental-evidences-supporting-the-benefits-of-exercise-training-in-heart-failure
#10
Marcelo H A Ichige, Marcelo G Pereira, Patrícia C Brum, Lisete C Michelini
Heart Failure (HF), a common end point for many cardiovascular diseases, is a syndrome with a very poor prognosis. Although clinical trials in HF have achieved important outcomes in reducing mortality, little is known about functional mechanisms conditioning health improvement in HF patients. In parallel with clinical studies, basic science has been providing important discoveries to understand the mechanisms underlying the pathophysiology of HF, as well as to identify potential targets for the treatment of this syndrome...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29021945/an-evaluation-of-instructive-feedback-to-teach-play-behavior-to-a-child-with-autism-spectrum-disorder
#11
Laura L Grow, Tiffany Kodak, Andrea Clements
Instructive feedback is used to expose learners to secondary targets during skill acquisition programs (Reichow & Wolery, in Journal of Applied Behavior Analysis, 44, 327-340, 2011; Werts, Wolery, Gast, & Holcombe, in Journal of Behavioral Education, 5, 55-75, 1995). Although unrelated feedback may have clinical utility in practice, very little research has evaluated unrelated instructive feedback, particularly for promoting play behavior (Colozzi, Ward, & Crotty, in Education and Training in Developmental Disabilities, 43, 226-248, 2008)...
September 2017: Behavior Analysis in Practice
https://www.readbyqxmd.com/read/29020241/infections-atherosclerosis-and-coronary-heart-disease
#12
Naga Venkata K Pothineni, Swathi Subramany, Kevin Kuriakose, Lily F Shirazi, Francesco Romeo, Prediman K Shah, Jawahar L Mehta
Atherosclerosis is a chronic inflammatory disease. Pathophysiological similarities between chronic infections and atherosclerosis triggered interest in a clinical association between these conditions. Various infectious microbes have been linked to atherosclerotic vascular disease in epidemiological studies. However, this association failed to satisfy the Koch's postulates of causation with multiple clinical trials demonstrating inefficacy of anti-infective therapies in mitigating atherosclerotic cardiovascular events...
July 12, 2017: European Heart Journal
https://www.readbyqxmd.com/read/29018840/sharing-individual-patient-and-parasite-level-data-through-the-worldwide-antimalarial-resistance-network-platform-a-qualitative-case-study
#13
Elizabeth Pisani, Stella Botchway
BACKGROUND: Increasingly, biomedical researchers are encouraged or required by research funders and journals to share their data, but there's very little guidance on how to do that equitably and usefully, especially in resource-constrained settings. We performed an in-depth case study of one data sharing pioneer: the WorldWide Antimalarial Resistance Network (WWARN). METHODS: The case study included a records review, a quantitative analysis of WAARN-related publications, in-depth interviews with 47 people familiar with WWARN, and a witness seminar involving a sub-set of 11 interviewees...
2017: Wellcome Open Research
https://www.readbyqxmd.com/read/29017690/the-range-and-scientific-value-of-randomized-trials
#14
Stefan Lange, Stefan Sauerland, Jörg Lauterberg, Jürgen Windeler
BACKGROUND: The randomized, controlled trial (RCT) is the gold standard of scientific evidence for the attribution of clinical effects (benefits and harms) to medical interventions. Many different designs for RCTs have been developed in order to counter legitimate critical objections and to better adapt the trials to the continually changing challenges that face clinical research. METHODS: The diversity and adaptability of randomized trial designs are presented and discussed on the basis of a selective literature review and specific illustrative examples...
September 22, 2017: Deutsches Ärzteblatt International
https://www.readbyqxmd.com/read/29017578/family-integrated-care-ficare-in-level-ii-neonatal-intensive-care-units-study-protocol-for-a-cluster-randomized-controlled-trial
#15
Karen M Benzies, Vibhuti Shah, Khalid Aziz, Wanrudee Isaranuwatchai, Luz Palacio-Derflingher, Jeanne Scotland, Jill Larocque, Kelly Mrklas, Esther Suter, Christopher Naugler, Henry T Stelfox, Radha Chari, Abhay Lodha
BACKGROUND: Every year, about 15 million of the world's infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [32(0/7)] to 33(6/7) weeks) and late preterm (34(0/7) to 36(6/7) weeks), and require care in a Level II NICU...
October 10, 2017: Trials
https://www.readbyqxmd.com/read/29017475/reliability-validity-and-responsiveness-of-the-german-self-reported-foot-and-ankle-score-sefas-in-patients-with-foot-or-ankle-surgery
#16
Dariusch Arbab, Katharina Kuhlmann, Christoph Schnurr, Bertil Bouillon, Christian Lüring, Dietmar König
BACKGROUND: Patient-reported outcome measures are a critical tool in evaluating the efficacy of orthopedic procedures and are increasingly used in clinical trials to assess outcomes of health care. The intention of this study was to develop and culturally adapt a German version of the Self-reported Foot and Ankle Score (SEFAS) and to evaluate reliability, validity and responsiveness. METHODS: According to Cross Cultural Adaptation of Self-Reported Measure guidelines forward and backward translation has been performed...
October 10, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/29016865/inability-of-positive-phase-ii-clinical-trials-of-investigational-treatments-to-subsequently-predict-positive-phase-iii-clinical-trials-in-glioblastoma
#17
Jacob J Mandel, Shlomit Yust-Katz, Akash J Patel, David Cachia, Diane Liu, Minjeong Park, Ying Yuan, Thomas A Kent, John F de Groot
Background: Glioblastoma is the most common primary malignant brain tumor in adults, but effective therapies are lacking. With the scarcity of positive phase III trials, which are increasing in cost, we examined the ability of positive phase II trials to predict statistically significant improvement in clinical outcomes of phase III trials. Methods: A PubMed search was conducted to identify phase III clinical trials performed in the past 25 years for patients with newly diagnosed or recurrent glioblastoma...
July 31, 2017: Neuro-oncology
https://www.readbyqxmd.com/read/28993313/checkpoint-inhibitors-spur-changes-in-trial-design
#18
(no author information available yet)
Given the success of checkpoint inhibitors and the desire to test them in combination with other immunotherapies and targeted therapies, hundreds of clinical trials have been launched. To most efficiently study these agents, researchers and the FDA are exploring the use of novel endpoints, the use of new preclinical models, and adaptive trial designs. However, the cost and demands associated with the conduct of increasingly sophisticated early-phase clinical trials are putting smaller companies and some academic medical centers at a disadvantage...
October 9, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28993031/targeting-atp-citrate-lyase-in-hyperlipidemia-and-metabolic-disorders
#19
REVIEW
Stephen L Pinkosky, Pieter H E Groot, Narendra D Lalwani, Gregory R Steinberg
Chronic overnutrition and a sedentary lifestyle promote imbalances in metabolism, often manifesting as risk factors for life-threating diseases such as atherosclerotic cardiovascular disease (ASCVD) and nonalcoholic fatty liver disease (NAFLD). Nucleocytosolic acetyl-coenzyme A (CoA) has emerged as a central signaling node used to coordinate metabolic adaptations in response to a changing nutritional status. ATP-citrate lyase (ACL) is the enzyme primarily responsible for the production of extramitochondrial acetyl-CoA and is thus strategically positioned at the intersection of nutrient catabolism and lipid biosynthesis...
October 6, 2017: Trends in Molecular Medicine
https://www.readbyqxmd.com/read/28992168/pulmonary-hypertension-related-to-systemic-sclerosis-points-to-consider-for-clinical-trials
#20
REVIEW
Marc Humbert, Manjit Singh, Daniel E Furst, Dinesh Khanna, James R Seibold
There are proven successful approaches to clinical trial design in pulmonary arterial hypertension (PAH), which in turn have led to the licensing of a number of effective therapies. SSc has been included in trials of World Health Organization Group 1 PAH but has been under-represented. Responses in outcomes as diverse as exercise capacity, quality of life, durability of drug effect and survival have been reduced in comparison with those seen in idiopathic PAH. The PAH community has achieved international and interdisciplinary consensus guidelines for future studies...
September 1, 2017: Rheumatology
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