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Clinical Trials: Journal of the Society for Clinical Trials

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https://www.readbyqxmd.com/read/28819997/comparisons-of-cancer-staging-systems-should-be-based-on-overall-performance-in-the-population
#1
Kathleen F Kerr, Michael LeBlanc, Holly Janes
No abstract text is available yet for this article.
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28819983/an-evaluation-of-the-effectiveness-of-a-risk-based-monitoring-approach-implemented-with-clinical-trials-involving-implantable-cardiac-medical-devices
#2
Christopher A Diani, Angie Rock, Phil Moll
Background Risk-based monitoring is a concept endorsed by the Food and Drug Administration to improve clinical trial data quality by focusing monitoring efforts on critical data elements and higher risk investigator sites. BIOTRONIK approached this by implementing a comprehensive strategy that assesses risk and data quality through a combination of operational controls and data surveillance. This publication demonstrates the effectiveness of a data-driven risk assessment methodology when used in conjunction with a tailored monitoring plan...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28797179/the-optimal-design-of-stepped-wedge-trials-with-equal-allocation-to-sequences-and-a-comparison-to-other-trial-designs
#3
Jennifer A Thompson, Katherine Fielding, James Hargreaves, Andrew Copas
Background/Aims We sought to optimise the design of stepped wedge trials with an equal allocation of clusters to sequences and explored sample size comparisons with alternative trial designs. Methods We developed a new expression for the design effect for a stepped wedge trial, assuming that observations are equally correlated within clusters and an equal number of observations in each period between sequences switching to the intervention. We minimised the design effect with respect to (1) the fraction of observations before the first and after the final sequence switches (the periods with all clusters in the control or intervention condition, respectively) and (2) the number of sequences...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28795844/sample-size-adjustment-designs-with-time-to-event-outcomes-a-caution
#4
Boris Freidlin, Edward L Korn
BACKGROUND: Sample size adjustment designs, which allow increasing the study sample size based on interim analysis of outcome data from a randomized clinical trial, have been increasingly promoted in the biostatistical literature. Although it is recognized that group sequential designs can be at least as efficient as sample size adjustment designs, many authors argue that a key advantage of these designs is their flexibility; interim sample size adjustment decisions can incorporate information and business interests external to the trial...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28795584/use-of-an-android-phone-application-for-automated-text-messages-in-international-settings-a-case-study-in-an-hiv-clinical-trial-in-st-petersburg-russia
#5
Leah S Forman, Gregory J Patts, Sharon M Coleman, Elena Blokhina, John Lu, Tatiana Yaroslavtseva, Natalia Gnatienko, Evgeny Krupitsky, Jeffrey H Samet, Christine E Chaisson
BACKGROUND/AIMS: Reproducible outcomes in clinical trials depend on adherence to study protocol. Short message service (also known as text message) reminders have been shown to improve clinical trial adherence in the United States and elsewhere. However, due to systematic differences in mobile data plans, languages, and technology, these systems are not easily translated to international settings. METHODS: To gauge technical capabilities for international projects, we developed SMSMessenger, an automated Android application that uses a US server to send medication reminders to participants in a clinical trial in St...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28795578/evaluating-biomarkers-for-prognostic-enrichment-of-clinical-trials
#6
Kathleen F Kerr, Jeremy Roth, Kehao Zhu, Heather Thiessen-Philbrook, Allison Meisner, Francis Perry Wilson, Steven Coca, Chirag R Parikh
BACKGROUND/AIMS: A potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment. METHODS: We identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28786330/risk-adapted-monitoring-is-not-inferior-to-extensive-on-site-monitoring-results-of-the-adamon-cluster-randomised-study
#7
Oana Brosteanu, Gabriele Schwarz, Peggy Houben, Ursula Paulus, Anke Strenge-Hesse, Ulrike Zettelmeyer, Anja Schneider, Dirk Hasenclever
Background According to Good Clinical Practice, clinical trials must protect rights and safety of patients and make sure that the trial results are valid and interpretable. Monitoring on-site has an important role in achieving these objectives; it controls trial conduct at trial sites and informs the sponsor on systematic problems. In the past, extensive on-site monitoring with a particular focus on formal source data verification often lost sight of systematic problems in study procedures that endanger Good Clinical Practice objectives...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28783972/motivations-enrollment-decisions-and-socio-demographic-characteristics-of-healthy-volunteers-in-phase-1-research
#8
Christine Grady, Gabriella Bedarida, Ninet Sinaii, Mark Anthony Gregorio, Ezekiel J Emanuel
BACKGROUND/AIM: Phase 1 trials with healthy volunteers are an integral step in drug development. Commentators worry about the possible exploitation of healthy volunteers because they are assumed to be disadvantaged, marginalized, and inappropriately influenced by the offer of money for research for which they do not appreciate the inherent risks. Yet there are limited data to support or refute these concerns. This study aims to describe the socio-demographic characteristics, motivations, and enrollment decision-making of a large cohort of healthy volunteers...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28776422/isotonic-designs-for-phase-i-trials-in-partially-ordered-groups
#9
Mark Conaway
BACKGROUND/AIMS: Dose-finding trials can be conducted such that patients are first stratified into multiple risk groups before doses are allocated. The risk groups are often completely ordered in that, for a fixed dose, the probability of toxicity is monotonically increasing across groups. In some trials, the groups are only partially ordered. For example, one of several groups in a trial may be known to have the least risk of toxicity for a given dose, but the ordering of the risk among the remaining groups may not be known...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28776417/university-of-pennsylvania-ninth-annual-conference-on-statistical-issues-in-clinical-trials-where-are-we-with-adaptive-clinical-trial-designs-afternoon-panel-discussion
#10
Jason T Connor, Angela DeMichele, Janet Wittes
No abstract text is available yet for this article.
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28776412/commentary-on-freidlin-and-korn
#11
Cyrus Mehta
No abstract text is available yet for this article.
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28776409/rejoinder
#12
Boris Freidlin, Edward L Korn
No abstract text is available yet for this article.
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28776406/proceedings-of-the-university-of-pennsylvania-ninth-annual-conference-on-statistical-issues-in-clinical-trials-where-are-we-with-adaptive-clinical-trial-designs
#13
Susan S Ellenberg, Jonas H Ellenberg
No abstract text is available yet for this article.
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28776405/power-estimation-in-biomarker-studies-where-events-are-already-observed
#14
Mei-Yin C Polley
Background The clinical utility of a new biomarker should ideally be established in a prospective randomized clinical trial. However, such trials are not always practical. As such, it is common for investigators to identify promising biomarkers using archived specimens and clinical data collected from previously completed therapeutic trials. Simon et al. defined such biomarker studies as prospective-retrospective studies and proposed specific conditions to satisfy for such evaluations to be more than hypothesis generating...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28766409/phase-1-healthy-volunteer-willingness-to-participate-and-enrollment-preferences
#15
Stephanie C Chen, Ninet Sinaii, Gabriella Bedarida, Mark A Gregorio, Ezekiel Emanuel, Christine Grady
BACKGROUND/AIMS: Healthy volunteers in phase 1 clinical trials contribute to the development of safe drugs and other biologics and accept risks and burdens without anticipated health benefits from participation. Although emerging data have shown that healthy volunteers are influenced by risk, some still worry that financial incentives lead them to take on unreasonable risk. Yet little is known about healthy volunteers' preferences and how they make choices about enrolling in research studies...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28764558/commentary-on-heath-et-al
#16
Virginia Kwitkowski, Selena Daniels, Gregory Reaman, Ann Farrell, Paul Kluetz
No abstract text is available yet for this article.
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28764555/repeated-measures-dose-finding-design-with-time-trend-detection-in-the-presence-of-correlated-toxicity-data
#17
Jun Yin, Xavier Paoletti, Daniel J Sargent, Sumithra J Mandrekar
BACKGROUND: Phase I trials are designed to determine the safety, tolerability, and recommended phase 2 dose of therapeutic agents for subsequent testing. The dose-finding paradigm has thus traditionally focused on identifying the maximum tolerable dose of an agent or combination therapy under the assumption that there is a non-decreasing relationship between dose-toxicity and dose-efficacy. The dose is typically determined based on the probability of severe toxicity observed during the first treatment cycle...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28747074/commentary-on-grady-et-al-using-poor-uninsured-minorities-to-test-the-safety-of-experimental-drugs
#18
Carl Elliott
No abstract text is available yet for this article.
July 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28743191/successful-utilization-of-an-electronic-pain-diary-in-a-multinational-phase-3-interventional-study-of-pediatric-sickle-cell-anemia
#19
Lori E Heath, Matthew M Heeney, Carolyn C Hoppe, Samuel Adjei, Tsiri Agbenyega, Mohamed Badr, Nicoletta Masera, Chunmei Zhou, Patricia B Brown, Joseph A Jakubowski, Carlton Dampier
BACKGROUND/AIMS: Patients with sickle cell anemia can experience recurrent pain episodes, which affect quality of life. The reported prevalence of pain is higher in studies using patient diaries than in healthcare facility utilization data. Determining Effects of Platelet Inhibition on Vaso-Occlusive Events was a multinational study that assessed the efficacy and safety of prasugrel in reducing the rate of vaso-occlusive events in children with sickle cell anemia (NCT01794000) and included an electronic patient-reported outcome diary to record pain occurrence...
July 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28743189/response-to-kerr-et-al
#20
Michael W Kattan, Thomas A Gerds
No abstract text is available yet for this article.
July 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
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