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Adaptive trial design

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https://www.readbyqxmd.com/read/28731517/mental-steps-differential-activation-of-internal-pacemakers-in-motor-imagery-and-in-mental-imitation-of-gait
#1
Lucia Maria Sacheli, Laura Zapparoli, Carlo De Santis, Matteo Preti, Catia Pelosi, Nicola Ursino, Alberto Zerbi, Giuseppe Banfi, Eraldo Paulesu
Gait imagery and gait observation can boost the recovery of locomotion dysfunctions; yet, a neurologically justified rationale for their clinical application is lacking as much as a direct comparison of their neural correlates. Using functional magnetic resonance imaging, we measured the neural correlates of explicit motor imagery of gait during observation of in-motion videos shot in a park with a steady cam (Virtual Walking task). In a 2 × 2 factorial design, we assessed the modulatory effect of gait observation and of foot movement execution on the neural correlates of the Virtual Walking task: in half of the trials, the participants were asked to mentally imitate a human model shown while walking along the same route (mental imitation condition); moreover, for half of all the trials, the participants also performed rhythmic ankle dorsiflexion as a proxy for stepping movements...
July 21, 2017: Human Brain Mapping
https://www.readbyqxmd.com/read/28729235/improving-adherence-to-web-based-and-mobile-technologies-for-people-with-psychosis-systematic-review-of-new-potential-predictors-of-adherence
#2
Clare Killikelly, Zhimin He, Clare Reeder, Til Wykes
BACKGROUND: Despite the boom in new technologically based interventions for people with psychosis, recent studies suggest medium to low rates of adherence to these types of interventions. The benefits will be limited if only a minority of service users adhere and engage; if specific predictors of adherence can be identified then technologies can be adapted to increase the service user benefits. OBJECTIVE: The study aimed to present a systematic review of rates of adherence, dropout, and approaches to analyzing adherence to newly developed mobile and Web-based interventions for people with psychosis...
July 20, 2017: JMIR MHealth and UHealth
https://www.readbyqxmd.com/read/28728594/implementing-the-efftox-dose-finding-design-in-the-matchpoint-trial
#3
Kristian Brock, Lucinda Billingham, Mhairi Copland, Shamyla Siddique, Mirjana Sirovica, Christina Yap
BACKGROUND: The Matchpoint trial aims to identify the optimal dose of ponatinib to give with conventional chemotherapy consisting of fludarabine, cytarabine and idarubicin to chronic myeloid leukaemia patients in blastic transformation phase. The dose should be both tolerable and efficacious. This paper describes our experience implementing EffTox in the Matchpoint trial. METHODS: EffTox is a Bayesian adaptive dose-finding trial design that jointly scrutinises binary efficacy and toxicity outcomes...
July 20, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28726572/successful-forearm-prosthesis-fitting-in-a-patient-with-epidermolysis-bullosa-dystrophica-case-report
#4
Carl Verduyn, Marie-Anne Morren, Marguerite Stas, Friedl Sinnaeve, Katarina Segers, Carlotte Kiekens
BACKGROUND: Epidermolysis bullosa dystrophica is a rare dermatological disease characterized by extreme skin fragility and elevated risk of developing a squamous cell carcinoma. In some cases, amputation of a limb is necessary. Case description and methods: A 37-year-old man with recessive, severe generalized epidermolysis bullosa dystrophica developed a squamous cell carcinoma on the right forearm requiring a below-elbow amputation. Preoperative advice concerning indication and level of amputation was given...
July 1, 2017: Prosthetics and Orthotics International
https://www.readbyqxmd.com/read/28722322/advanced-methods-for-dose-and-regimen-finding-during-drug-development-summary-of-the-ema-efpia-workshop-on-dose-finding-london-4-5-december-2014
#5
F T Musuamba, E Manolis, N Holford, Sya Cheung, L E Friberg, K Ogungbenro, M Posch, Jwt Yates, S Berry, N Thomas, S Corriol-Rohou, B Bornkamp, F Bretz, A C Hooker, P H Van der Graaf, J F Standing, J Hay, S Cole, V Gigante, K Karlsson, T Dumortier, N Benda, F Serone, S Das, A Brochot, F Ehmann, R Hemmings, I Skottheim Rusten
Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late-stage attritions in clinical development and postmarketing commitments required by regulatory institutions. In an effort to shift the current paradigm in dose and regimen selection and highlight the availability and usefulness of well-established and regulatory-acceptable methods, the European Medicines Agency (EMA) in collaboration with the European Federation of Pharmaceutical Industries Association (EFPIA) hosted a multistakeholder workshop on dose finding (London 4-5 December 2014)...
July 19, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28722089/-how-to-carry-out-high-quality-clinical-trial
#6
Lai Xu, Yi Xiao
Evidence-based medicine derived from large-scale clinical trials has been widely accepted by clinicians, which strongly motivates the clinicians in medical institutions to conduct or participate in clinical trials. However, how to improve the clinical trial quality and management to achieve worldwide acceptance still remains challenging. By analyzing the difficulties faced by the majority of large Chinese clinical institutions and the opportunities during the evolvement of research modes, this paper proposes to improve the quality of clinical trial by closely following the domain development, raising clinical research thinking, ensuring rigorous research design, standardizing the steps and details of each operational session, as well as establishing a collaborative and well-communicated team...
July 25, 2017: Zhonghua Wei Chang Wai Ke za Zhi, Chinese Journal of Gastrointestinal Surgery
https://www.readbyqxmd.com/read/28720094/a-literature-review-of-applied-adaptive-design-methodology-within-the-field-of-oncology-in-randomised-controlled-trials-and-a-proposed-extension-to-the-consort-guidelines
#7
Pankaj Mistry, Janet A Dunn, Andrea Marshall
BACKGROUND: The application of adaptive design methodology within a clinical trial setting is becoming increasingly popular. However the application of these methods within trials is not being reported as adaptive designs hence making it more difficult to capture the emerging use of these designs. Within this review, we aim to understand how adaptive design methodology is being reported, whether these methods are explicitly stated as an 'adaptive design' or if it has to be inferred and to identify whether these methods are applied prospectively or concurrently...
July 18, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28720039/the-revamp-trial-to-evaluate-hiv-resistance-testing-in-sub-saharan-africa-a-case-study-in-clinical-trial-design-in-resource-limited-settings-to-optimize-effectiveness-and-cost-effectiveness-estimates
#8
Mark J Siedner, Mwebesa B Bwana, Mahomed-Yunus S Moosa, Michelle Paul, Selvan Pillay, Suzanne McCluskey, Isaac Aturinda, Kevin Ard, Winnie Muyindike, Pravikrishnen Moodley, Jaysingh Brijkumar, Tamlyn Rautenberg, Gavin George, Brent Johnson, Rajesh T Gandhi, Henry Sunpath, Vincent C Marconi
BACKGROUND: In sub-Saharan Africa, rates of sustained HIV virologic suppression remain below international goals. HIV resistance testing, while common in resource-rich settings, has not gained traction due to concerns about cost and sustainability. OBJECTIVE: We designed a randomized clinical trial to determine the feasibility, effectiveness, and cost-effectiveness of routine HIV resistance testing in sub-Saharan Africa. APPROACH: We describe challenges common to intervention studies in resource-limited settings, and strategies used to address them, including: (1) optimizing generalizability and cost-effectiveness estimates to promote transition from study results to policy; (2) minimizing bias due to patient attrition; and (3) addressing ethical issues related to enrollment of pregnant women...
July 18, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28719221/biosimilars-biologics-that-meet-patients-needs-and-healthcare-economics
#9
Mark McCamish, William Yoon, James McKay
Biologics have revolutionized medical care, yet uniform access to these effective medicines remains difficult due to the increasing costs of healthcare. As patent exclusivity on the early biologics wanes, regulatory and legal systems are adapting to bring competition to the field in the form of biosimilars. Biosimilars are biologics that offer the same clinical benefit in one or more of the same indications as the reference biologic drug and bring competition to the biologics space. Legislation creating a pathway resulting in the first US approvals of biosimilars has been in place since 2010, but the regulatory methodology and science of evaluating the sameness of two biologics has been in use for decades...
September 2016: American Journal of Managed Care
https://www.readbyqxmd.com/read/28717940/alopecia-areata-a-comprehensive-review-of-pathogenesis-and-management
#10
REVIEW
Ralph M Trüeb, Maria Fernanda Reis Gavazzoni Dias
Alopecia areata is a common hair loss condition that is characterized by acute onset of non-scarring hair loss in usually sharply defined areas ranging from small patches to extensive or less frequently diffuse involvement. Depending on its acuity and extent, hair loss is an important cause of anxiety and disability. The current understanding is that the condition represents an organ-specific autoimmune disease of the hair follicle with a genetic background. Genome-wide association studies provide evidence for the involvement of both innate and acquired immunity in the pathogenesis, and mechanistic studies in mouse models of alopecia areata have specifically implicated an IFN-γ-driven immune response, including IFNγ, IFNγ-induced chemokines and cytotoxic CD8 T cells as the main drivers of disease pathogenesis...
July 17, 2017: Clinical Reviews in Allergy & Immunology
https://www.readbyqxmd.com/read/28716135/assessing-the-link-between-implementation-fidelity-and-health-outcomes-for-a-trial-of-intensive-case-management-by-community-health-workers-a-mixed-methods-study-protocol
#11
Barbara Schmidt, Kerrianne Watt, Robyn McDermott, Jane Mills
BACKGROUND: Better systems of care are required to address chronic disease in Indigenous people to ensure they can access all their care needs. Health research has produced evidence about effective models of care and chronic disease strategies to address Indigenous health, however the transfer of research findings into routine clinical practice has proven challenging. Complex interventions, such as those related to chronic disease, have many components that are often poorly implemented and hence rarely achieve implementation fidelity...
July 17, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28713646/progression-of-local-glaucomatous-damage-near-fixation-as-seen-with-adaptive-optics-imaging
#12
Donald C Hood, Dongwon Lee, Ravivarn Jarukasetphon, Jason Nunez, Maria A Mavrommatis, Richard B Rosen, Robert Ritch, Alfredo Dubra, Toco Y P Chui
PURPOSE: Deep glaucomatous defects near fixation were followed over time with an adaptive optics-scanning light ophthalmoscope (AO-SLO) to better understand the progression of these defects and to explore the use of AO-SLO in detecting them. METHODS: Six eyes of 5 patients were imaged with an AO-SLO from 2 to 4 times for a range of 14.6 to 33.6 months. All eyes had open-angle glaucoma with deep defects in the superior visual field (VF) near fixation as defined by 10-2 VFs with 5 or more points less than -15 dB; two of the eyes had deep defects in the inferior VF as well...
July 2017: Translational Vision Science & Technology
https://www.readbyqxmd.com/read/28713032/psychosocial-rehabilitation-after-war-trauma-with-adaptive-disclosure-design-and-rationale-of-a-comparative-efficacy-trial
#13
Julie D Yeterian, Danielle S Berke, Brett T Litz
BACKGROUND: Posttraumatic stress disorder (PTSD) from warzone exposure is associated with chronic and disabling social and occupational problems. However, functional impairment is rarely assessed or targeted directly in PTSD treatments, which instead focus on symptom reduction. Trauma-related contributors to diminished functioning, including guilt, shame, and anger resulting from morally compromising or loss-based war experiences, are also underemphasized. The goal of this clinical trial is to fill a substantial gap in the treatment of military-related PTSD by testing a modified Adaptive Disclosure (AD) therapy for war-related PTSD stemming from moral injury and traumatic loss focused on improving psychosocial functioning AD...
July 13, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28712612/patient-reported-outcome-and-observer-reported-outcome-assessment-in-rare-disease-clinical-trials-an-ispor-coa-emerging-good-practices-task-force-report
#14
Katy Benjamin, Margaret K Vernon, Donald L Patrick, Eleanor Perfetto, Sandra Nestler-Parr, Laurie Burke
BACKGROUND: Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. OBJECTIVE: To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials...
July 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28711113/effects-of-tailored-and-act-influenced-internet-based-cbt-for-eating-disorders-and-the-relation-between-knowledge-acquisition-and-outcome-a-randomized-controlled-trial
#15
Sandra Weineland Strandskov, Ata Ghaderi, Hedvig Andersson, Nicole Parmskog, Emelie Hjort, Anna Svanberg Wärn, Maria Jannert, Gerhard Andersson
This is the first trial to investigate the outcome of tailored and ACT-influenced, cognitive behavioral Internet treatment for eating disorder psychopathology, and the relation between knowledge acquisition and outcome. This study utilized a randomized controlled design, with computer-based allocation to treatment or waiting list control group. Participants were recruited via advertisements in social media and newspapers in Sweden. Participants fulfilling the criteria for bulimia nervosa (BN), or Eating Disorder Not Otherwise Specified (EDNOS), with a BMI above 17...
September 2017: Behavior Therapy
https://www.readbyqxmd.com/read/28708290/rationale-and-design-of-the-adaptresponse-trial-a-prospective-randomized-study-of-cardiac-resynchronization-therapy-with-preferential-adaptive-left-ventricular-only-pacing
#16
Gerasimos Filippatos, David Birnie, Michael R Gold, Bart Gerritse, Ahmad Hersi, Sandra Jacobs, Kengo Kusano, Christophe Leclercq, Wilfried Mullens, Bruce L Wilkoff
The AdaptResponse trial is designed to test the hypothesis that preferential adaptive left ventricular-only pacing with the AdaptivCRT(®) algorithm reduces the incidence of the combined endpoint of all-cause mortality and intervention for heart failure (HF) decompensation, compared with conventional cardiac resynchronization therapy (CRT), among patients with a CRT indication, left bundle branch block (LBBB) and normal atrioventricular (AV) conduction. The AdaptResponse study is a prospective, randomized, controlled, single-blinded, multicentre, clinical trial (ClinicalTrials...
July 2017: European Journal of Heart Failure
https://www.readbyqxmd.com/read/28703939/adaptation-of-the-by-band-randomized-clinical-trial-to-by-band-sleeve-to-include-a-new-intervention-and-maintain-relevance-of-the-study-to-practice
#17
C A Rogers, B C Reeves, J Byrne, J L Donovan, G Mazza, S Paramasivan, R C Andrews, S Wordsworth, J Thompson, J M Blazeby, R Welbourn
BACKGROUND: Recruitment into surgical RCTs can be threatened if new interventions available outside the trial compete with those being evaluated. Adapting the trial to include the new intervention may overcome this issue, yet this is not often done in surgery. This paper describes the challenges, rationale and methods for adapting an RCT to include a new intervention. METHODS: The By-Band study was designed in the UK in 2009-2010 to compare the effectiveness of laparoscopic adjustable gastric band and Roux-en-Y gastric bypass for severe obesity...
August 2017: British Journal of Surgery
https://www.readbyqxmd.com/read/28701395/preferential-targeting-of-conserved-gag-regions-after-vaccination-with-a-heterologous-dna-prime-modified-vaccinia-ankara-mva-boost-hiv-1-vaccine-regimen
#18
Asli Bauer, Lilli Podola, Philipp Mann, Marco Missanga, Antelmo Haule, Lwitiho Sudi, Charlotta Nilsson, Bahati Kaluwa, Cornelia Lueer, Maria Mwakatima, Patricia J Munseri, Leonard Maboko, Merlin L Robb, Sodsai Tovanabutra, Gustavo Kijak, Mary Marovich, Sheena McCormack, Sarah Joseph, Eligius Lyamuya, Britta Wahren, Eric Sandström, Gunnel Biberfeld, Michael Hoelscher, Muhammad Bakari, Arne Kroidl, Christof Geldmacher
Prime-boost vaccination strategies against HIV-1 often include multiple variants for a given immunogen for better coverage of the extensive viral diversity. To study the immunologic effects of this approach, we characterized breadth, phenotype, function and specificity of Gag-specific T cells induced by a DNA-prime Modified Vaccinia Ankara (MVA)-boost vaccination strategy, which uses mismatched Gag immunogens in the TamoVac 01 phase IIa trial. Healthy Tanzanian volunteers received three injections of the DNA-SMI vaccine encoding for a subtype B and AB-recombinant Gagp37 and two vaccinations with MVA-CMDR encoding subtype A Gagp55 Gag-specific T-cell responses were studied in 42 vaccinees using fresh peripheral blood mononuclear cells...
July 12, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28699560/dengue-occurrence-relations-and-serology-cross-sectional-analysis-of-results-from-the-guerrero-state-mexico-baseline-for-a-cluster-randomised-controlled-trial-of-community-mobilisation-for-dengue-prevention
#19
Elizabeth Nava-Aguilera, Arcadio Morales-Pérez, Alejandro Balanzar-Martínez, Ofelia Rodríguez-Ramírez, Abel Jiménez-Alejo, Miguel Flores-Moreno, David Gasga-Salinas, José Legorreta-Soberanis, Sergio Paredes-Solís, Pedro Antonio Morales-Nava, María de Lourdes Soto-Ríos, Robert J Ledogar, Joséfina Coloma, Eva Harris, Neil Andersson
BACKGROUND: The Mexican arm of the Camino Verde trial of community mobilisation for dengue prevention covered three coastal regions of Guerrero state: Acapulco, Costa Grande and Costa Chica. A baseline cross-sectional survey provided data for community mobilisation and for adapting the intervention design to concrete conditions in the intervention areas. METHODS: Trained field teams constructed community profiles in randomly selected clusters, based on observation and key informant interviews...
May 30, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28695517/high-throughput-colorimetric-assay-for-identifying-parp-1-inhibitors-using-a-large-small-molecule-collection
#20
Elena Kotova, Alexei V Tulin
Poly(ADP-ribose)polymerase 1 (PARP-1) protein became a popular target for treatment of several types of cancer. A number of PARP-1 inhibitors are currently in clinical trials. Most of them were designed competitors with NAD for a binding site on PARP-1 molecule. This strategy resulted in a discovery of mainly nucleotide-like PARP-1 inhibitors, which may target not only PARP-1 but also other pathways involving NAD and other nucleotides. Many cancer types demonstrate rapid development of resistance to NAD-like PARP-1 inhibitors...
2017: Methods in Molecular Biology
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