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Adaptive trial design

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https://www.readbyqxmd.com/read/28109405/challenges-and-methodology-in-the-incorporation-of-biomarkers-in-cancer-clinical-trials
#1
REVIEW
Charlotte S Wilhelm-Benartzi, Shahrul Mt-Isa, Francesca Fiorentino, Robert Brown, Deborah Ashby
Biomarkers can be used to establish more homogeneous groups using the genetic makeup of the tumour to inform the selection of treatment for each individual patient. However, proper preclinical work and stringent validation are needed before taking forward biomarkers into confirmatory studies. Despite the challenges, incorporation of biomarkers into clinical trials could better target appropriate patients, and potentially be lifesaving. The authors conducted a systematic review to describe marker-based and adaptive design methodology for their integration in clinical trials, and to further describe the associated practical challenges...
February 2017: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/28108460/enhancer-remodeling-during-adaptive-bypass-to-mek-inhibition-is-attenuated-by-pharmacological-targeting-of-the-p-tefb-complex
#2
Jon S Zawistowski, Samantha M Bevill, Daniel R Goulet, Timothy J Stuhlmiller, Adriana S Beltran, Jose F Olivares-Quintero, Darshan Singh, Noah Sciaky, Joel S Parker, Naim U Rashid, Xin Chen, James S Duncan, Martin C Whittle, Steven P Angus, Sara Hanna Velarde, Brian T Golitz, Xiaping He, Charlene Santos, David B Darr, Kristalyn Gallagher, Lee M Graves, Charles M Perou, Lisa A Carey, H Shelton Earp, Gary L Johnson
Targeting the dysregulated BRaf-MEK-ERK pathway in cancer has increasingly emerged in clinical trial design. Despite clinical responses in specific cancers using inhibitors targeting BRaf and MEK, resistance develops often involving non-genomic adaptive bypass mechanisms. Inhibition of MEK1/2 by trametinib in triple negative breast cancer (TNBC) patients induced dramatic transcriptional responses, including upregulation of receptor tyrosine kinases (RTKs) comparing tumor samples before and after one week of treatment...
January 20, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28107350/maternal-and-newborn-health-in-karnataka-state-india-the-community-level-interventions-for-pre-eclampsia-clip-trial-s-baseline-study-results
#3
Mrutynjaya B Bellad, Marianne Vidler, Narayan V Honnungar, Ashalata Mallapur, Umesh Ramadurg, Umesh Charanthimath, Geetanjali Katageri, Shashidhar Bannale, Avinash Kavi, Chandrashekhar Karadiguddi, Sumedha Sharma, Tang Lee, Jing Li, Beth Payne, Laura Magee, Peter von Dadelszen, Richard Derman, Shivaprasad S Goudar
Existing vital health statistics registries in India have been unable to provide reliable estimates of maternal and newborn mortality and morbidity, and region-specific health estimates are essential to the planning and monitoring of health interventions. This study was designed to assess baseline rates as the precursor to a community-based cluster randomized control trial (cRCT)-Community Level Interventions for Pre-eclampsia (CLIP) Trial (NCT01911494; CTRI/2014/01/004352). The objective was to describe baseline demographics and health outcomes prior to initiation of the CLIP trial and to improve knowledge of population-level health, in particular of maternal and neonatal outcomes related to hypertensive disorders of pregnancy, in northern districts the state of Karnataka, India...
2017: PloS One
https://www.readbyqxmd.com/read/28100438/high-dose-rifampicin-moxifloxacin-and-sq109-for-treating-tuberculosis-a-multi-arm-multi-stage-randomised-controlled-trial
#4
Martin J Boeree, Norbert Heinrich, Rob Aarnoutse, Andreas H Diacon, Rodney Dawson, Sunita Rehal, Gibson S Kibiki, Gavin Churchyard, Ian Sanne, Nyanda E Ntinginya, Lilian T Minja, Robert D Hunt, Salome Charalambous, Madeleine Hanekom, Hadija H Semvua, Stellah G Mpagama, Christina Manyama, Bariki Mtafya, Klaus Reither, Robert S Wallis, Amour Venter, Kim Narunsky, Anka Mekota, Sonja Henne, Angela Colbers, Georgette Plemper van Balen, Stephen H Gillespie, Patrick P J Phillips, Michael Hoelscher
BACKGROUND: Tuberculosis is the world's leading infectious disease killer. We aimed to identify shorter, safer drug regimens for the treatment of tuberculosis. METHODS: We did a randomised controlled, open-label trial with a multi-arm, multi-stage design. The trial was done in seven sites in South Africa and Tanzania, including hospitals, health centres, and clinical trial centres. Patients with newly diagnosed, rifampicin-sensitive, previously untreated pulmonary tuberculosis were randomly assigned in a 1:1:1:1:2 ratio to receive (all orally) either 35 mg/kg rifampicin per day with 15-20 mg/kg ethambutol, 20 mg/kg rifampicin per day with 400 mg moxifloxacin, 20 mg/kg rifampicin per day with 300 mg SQ109, 10 mg/kg rifampicin per day with 300 mg SQ109, or a daily standard control regimen (10 mg/kg rifampicin, 5 mg/kg isoniazid, 25 mg/kg pyrazinamide, and 15-20 mg/kg ethambutol)...
January 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28100190/translation-of-a-tailored-nutrition-and-resistance-exercise-intervention-for-elderly-people-to-a-real-life-setting-adaptation-process-and-pilot-study
#5
Ellen Ji van Dongen, Joanne N Leerlooijer, Jan M Steijns, Michael Tieland, Lisette Cpgm de Groot, Annemien Haveman-Nies
BACKGROUND: Combining increased dietary protein intake and resistance exercise training for elderly people is a promising strategy to prevent or counteract the loss of muscle mass and decrease the risk of disabilities. Using findings from controlled interventions in a real-life setting requires adaptations to the intervention and working procedures of healthcare professionals (HCPs). The aim of this study is to adapt an efficacious intervention for elderly people to a real-life setting (phase one) and test the feasibility and potential impact of this prototype intervention in practice in a pilot study (phase two)...
January 18, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28100176/effect-of-training-and-structured-medication-review-on-medication-appropriateness-in-nursing-home-residents-and-on-cooperation-between-health-care-professionals-the-intherakt-study-protocol
#6
Angelika Mahlknecht, Nadja Nestler, Ulrike Bauer, Nadine Schüßler, Jochen Schuler, Sebastian Scharer, Ralf Becker, Isabel Waltering, Georg Hempel, Oliver Schwalbe, Maria Flamm, Jürgen Osterbrink
BACKGROUND: Pharmacotherapy in residents of nursing homes is critical due to the special vulnerability of this population. Medical care and interprofessional communication in nursing homes are often uncoordinated. As a consequence, polypharmacy and inappropriate medication use are common and may lead to hospitalizations and health hazards. The aim of this study is to optimize communication between the involved professional groups by specific training and by establishing a structured medication review process, and to improve medication appropriateness and patient-relevant health outcomes for residents of nursing homes...
January 18, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28099993/conditional-estimation-in-two-stage-adaptive-designs
#7
Per Broberg, Frank Miller
We consider conditional estimation in two-stage sample size adjustable designs and the consequent bias. More specifically, we consider a design which permits raising the sample size when interim results look rather promising, and which retains the originally planned sample size when results look very promising. The estimation procedures reported comprise the unconditional maximum likelihood, the conditionally unbiased Rao-Blackwell estimator, the conditional median unbiased estimator, and the conditional maximum likelihood with and without bias correction...
January 18, 2017: Biometrics
https://www.readbyqxmd.com/read/28097625/effects-of-a-web-based-intervention-on-women-s-breast-health-behaviors
#8
Deborah J Bowen, Robert Robbins, Nigel Bush, Hendrika Meischke, Abi Ludwig, Jean Wooldridge
Helping women make choices to reduce cancer risk and to improve breast health behaviors is important, but the best ways to reach more people with intervention assistance is not known. To test the efficacy of a web-based intervention designed to help women make better breast health choices, we adapted our previously tested, successful breast health intervention package to be delivered on the Internet, and then we tested it in a randomized trial. We recruited women from the general public to be randomized to either an active intervention group or a delayed intervention control group...
January 17, 2017: Translational Behavioral Medicine
https://www.readbyqxmd.com/read/28095850/building-system-capacity-for-the-integration-of-mental-health-at-the-level-of-primary-care-in-tunisia-a-study-protocol-in-global-mental-health
#9
Jessica Spagnolo, François Champagne, Nicole Leduc, Myra Piat, Wahid Melki, Fatma Charfi, Marc Laporta
BACKGROUND: In low- and middle-income countries (LMICs), addressing the high prevalence of mental disorders is a challenge given the limited number and unequal distribution of specialists, as well as scarce resources allocated to mental health. The Mental Health Gap Action Programme (mhGAP) and its accompanying Intervention Guide (IG), developed by the World Health Organization (WHO), aim to address this challenge by training non-specialists such as general practitioners (GPs) in mental health care...
January 17, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28095827/lessons-learned-from-the-london-exercise-and-pregnant-leap-smokers-randomised-controlled-trial-process-evaluation-implications-for-the-design-of-physical-activity-for-smoking-cessation-interventions-during-pregnancy
#10
Nikoletta Giatras, Elisabeth Wanninkhof, Miranda Leontowitsch, Beth Lewis, Adrian Taylor, Sue Cooper, Michael Ussher
BACKGROUND: The challenges of delivering interventions for pregnant smokers have been poorly documented. Also, the process of promoting a physical activity intervention for pregnant smokers has not been previously recorded. This study describes the experiences of researchers conducting a randomised controlled trial of physical activity as an aid to smoking cessation during pregnancy and explores how the effectiveness of future interventions could be improved. METHODS: Two focus groups, with independent facilitators, were conducted with six researchers who had enrolled pregnant smokers in the LEAP trial, provided the interventions, and administered the research measures...
January 17, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28092390/asthma-comparing-the-impact-of-vitamin-d-versus-uvr-on-clinical-and-immune-parameters
#11
Kylie A Morgan, Elizabeth H Mann, Antony R Young, Catherine M Hawrylowicz
The incidence of asthma has increased markedly since the 1960s and is currently estimated to affect more than 300 million individuals worldwide. A number of environmental factors are implicated in asthma pathogenesis, one of which is vitamin D. Vitamin D deficiency is a global health concern and has increased in parallel with asthma incidence. Epidemiological studies report associations between low vitamin D status, assessed as circulating levels of 25-hydroxyvitamin D, with asthma incidence, severity, exacerbations and responses to treatment...
January 16, 2017: Photochemical & Photobiological Sciences
https://www.readbyqxmd.com/read/28090605/domain-adaptation-methods-for-improving-lab-to-field-generalization-of-cocaine-detection-using-wearable-ecg
#12
Annamalai Natarajan, Gustavo Angarita, Edward Gaiser, Robert Malison, Deepak Ganesan, Benjamin M Marlin
Mobile health research on illicit drug use detection typically involves a two-stage study design where data to learn detectors is first collected in lab-based trials, followed by a deployment to subjects in a free-living environment to assess detector performance. While recent work has demonstrated the feasibility of wearable sensors for illicit drug use detection in the lab setting, several key problems can limit lab-to-field generalization performance. For example, lab-based data collection often has low ecological validity, the ground-truth event labels collected in the lab may not be available at the same level of temporal granularity in the field, and there can be significant variability between subjects...
September 2016: Proceedings of the ACM International Conference on Ubiquitous Computing
https://www.readbyqxmd.com/read/28089763/comparison-of-multi-arm-multi-stage-design-and-adaptive-randomization-in-platform-clinical-trials
#13
REVIEW
Jianchang Lin, Veronica Bunn
Platforms trials are clinical trials that allow for concurrent evaluations of multiple treatments, thus allowing for more efficient and ethical studies compared to traditional two-arm trials. Conventional group-sequential multi-arm multi-stage (MAMS) designs use pre-specified stopping boundaries and treatment selection rules to determine if experimental treatments should be dropped. Flexible MAMS designs allow for interim modifications to the design plan without compromising error rates. Bayesian response adaptive randomization (BRAR) designs increase patient allocation to treatment arms that are performing well during the course of the trial...
January 12, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28089762/long-terms-results-of-a-trial-of-concurrent-chemotherapy-and-escalating-doses-of-radiation-for-unresectable-non-small-cell-lung-cancer-ncctg-n0028-alliance
#14
Steven E Schild, Shauna L Hillman, Angelina D Tan, Helen J Ross, William L McGinnis, Yolanda A Garces, David L Graham, Alex A Adjei, James R Jett
INTRODUCTION OR HYPOTHESIS: This phase I/II trial was originally designed to determine the maximally tolerated dose(MTD) of thoracic radiotherapy(TRT) as part of a combined modality approach. This report includes the long-term outcome of patients treated on this study. The phase II portion was never completed as RTOG-0617 opened before it was concluded. METHODS: The MTD was defined as 74Gy in 37 fractions in this study. Twenty-five patients with unresectable non-small cell lung cancer(NSCLC) were treated with 2Gy daily fractions and concurrent weekly carboplatin and paclitaxel...
January 12, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/28089759/using-pupil-size-and-heart-rate-to-infer-affective-states-during-behavioral-neurophysiology-and-neuropsychology-experiments
#15
Andrew R Mitz, Ravi V Chacko, Philip T Putnam, Peter H Rudebeck, Elisabeth A Murray
BACKGROUND: Nonhuman primates (NHPs) are a valuable research model because of their behavioral, physiological and neuroanatomical similarities to humans. In the absence of language, autonomic activity can provide crucial information about cognitive and affective states during single-unit recording, inactivation and lesion studies. Methods standardized for use in humans are not easily adapted to NHPs and detailed guidance has been lacking. NEW METHOD: We provide guidance for monitoring heart rate and pupil size in the behavioral neurophysiology setting by addressing the methodological issues, pitfalls and solutions for NHP studies...
January 13, 2017: Journal of Neuroscience Methods
https://www.readbyqxmd.com/read/28086836/an-internet-based-self-help-intervention-for-older-adults-after-marital-bereavement-separation-or-divorce-study-protocol-for-a-randomized-controlled-trial
#16
Jeannette Brodbeck, Thomas Berger, Hans Joerg Znoj
BACKGROUND: Marital bereavement and separation or divorce are among the most stressful critical life events in later life. These events require a dissolution of social and emotional ties, adjustments in daily routine and changes in identity and perspectives for the future. After a normative grief or distress reaction, most individuals cope well with the loss. However, some develop a prolonged grief reaction. Internet-based self-help interventions have proved beneficial for a broad range of disorders, including complicated grief...
January 13, 2017: Trials
https://www.readbyqxmd.com/read/28074476/drug-development-trial-design-and-endpoints-in-oncology-adapting-to-rapidly-changing-science
#17
Gideon M Blumenthal, Kirsten B Goldberg, Richard Pazdur
No abstract text is available yet for this article.
January 11, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28067166/stem-cell-genetic-therapy-for-fanconi-anemia-a-new-hope
#18
Helmut Hanenberg, Katharina Roellecke, Constanze Wiek
Fanconi anemia (FA) is a rare inherited DNA disorder clinically characterized by congenital malformations, progressive bone marrow failure, and cancer susceptibility. Due to a strong survival advantage of spontaneously corrected 'normal' hematopoietic stem cells (HSCs) in a few patients, FA is considered a model disorder for genetic correction of autologous stem cells, where genetically corrected stem cells and their progeny have a strong in vivo selective advantage, ultimately leading to normal hematopoiesis...
January 9, 2017: Current Gene Therapy
https://www.readbyqxmd.com/read/28065490/burnout-among-cardiologists
#19
EDITORIAL
Jeffrey B Michel, Denisse M Sangha, John P Erwin
Burnout is a loss of enthusiasm for work, cynicism, and a low sense of accomplishment. Loss of autonomy and authority, complex regulatory requirements, report cards, quality metrics, the rise of large integrated health care systems, and the demise of solo practice are just a few realities of medical practice that contribute to physician burnout. Physicians suffering burnout often focus on compensation and perceived status as antidotes, although evidence suggests they play no role. Randomized controlled trials suggest that interventions designed to improve coping and resiliency including cognitive behavioral therapy and physical and mental relaxations to reduce stress can be effective...
December 18, 2016: American Journal of Cardiology
https://www.readbyqxmd.com/read/28052042/a-printed-yagi-uda-antenna-for-application-in-magnetic-resonance-thermometry-guided-microwave-hyperthermia-applicators
#20
Margarethus Marius Paulides, R Mestrom, Ghassan Salim, Bedilu Adela, Wouter Numan, Tomas Drizdal, Desmond Yeo, Bart Smolders
Biological studies and clinical trials show that addition of hyperthermia stimulates conventional cancer treatment modalities and significantly improves treatment outcome. This supra-additive stimulation can be optimized by adaptive hyperthermia to counteract strong and dynamic thermoregulation. The only clinically proven method for the 3D non-invasive temperature monitoring required is by magnetic resonance (MR) temperature imaging, but the currently available set of MR compatible hyperthermia applicators lack the degree of heat control required...
January 4, 2017: Physics in Medicine and Biology
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