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Clinical Trials: Journal of the Society for Clinical Trials

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https://www.readbyqxmd.com/read/28709387/response
#1
Christine Grady
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/28693389/primary-care-physicians-attitudes-and-beliefs-about-cancer-clinical-trials
#2
Carma L Bylund, Elisa S Weiss, Margo Michaels, Shilpa Patel, Thomas A D'Agostino, Emily B Peterson, Maria Christina Binz-Scharf, Natasha Blakeney, M Diane McKee
BACKGROUND/AIMS: Cancer clinical trials give patients access to state-of-the-art treatments and facilitate the translation of findings into mainstream clinical care. However, patients from racial and ethnic minority groups remain underrepresented in clinical trials. Primary care physicians are a trusted source of information for patients, yet their role in decision-making about cancer treatment and referrals to trial participation has received little attention. The aim of this study was to determine physicians' knowledge, attitudes, and beliefs about cancer clinical trials, their experience with trials, and their interest in appropriate training about trials...
July 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28675302/development-of-a-practical-approach-to-expert-elicitation-for-randomised-controlled-trials-with-missing-health-outcomes-application-to-the-improve-trial
#3
Alexina J Mason, Manuel Gomes, Richard Grieve, Pinar Ulug, Janet T Powell, James Carpenter
BACKGROUND/AIMS: The analyses of randomised controlled trials with missing data typically assume that, after conditioning on the observed data, the probability of missing data does not depend on the patient's outcome, and so the data are 'missing at random' . This assumption is usually implausible, for example, because patients in relatively poor health may be more likely to drop out. Methodological guidelines recommend that trials require sensitivity analysis, which is best informed by elicited expert opinion, to assess whether conclusions are robust to alternative assumptions about the missing data...
July 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28670910/commentary-on-tin%C3%A3-et-al
#4
Lori E Dodd
No abstract text is available yet for this article.
June 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28670909/evidence-of-bias-in-randomized-clinical-trials-of-hepatitis-c-interferon-therapies
#5
Fabio Tinè, Massimo Attanasio, Vito M R Muggeo, Ciprian M Crainiceanu
INTRODUCTION: Bias may occur in randomized clinical trials in favor of the new experimental treatment because of unblinded assessment of subjective endpoints or wish bias. Using results from published trials, we analyzed and compared the treatment effect of hepatitis C antiviral interferon therapies experimental or control. METHODS: Meta-regression of trials enrolling naïve hepatitis C virus patients that underwent four therapies including interferon alone or plus ribavirin during past years...
June 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28653550/group-sequential-designs-for-stepped-wedge-cluster-randomised-trials
#6
Michael J Grayling, James Ms Wason, Adrian P Mander
BACKGROUND/AIMS: The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency gains and ethical benefits. We address this by discussing how established group sequential methodology can be adapted for stepped-wedge designs...
June 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28649874/a-web-application-for-evaluating-phase-i-methods-using-a-non-parametric-optimal-benchmark
#7
Nolan A Wages, Nikole Varhegyi
BACKGROUND/AIMS: In evaluating the performance of Phase I dose-finding designs, simulation studies are typically conducted to assess how often a method correctly selects the true maximum tolerated dose under a set of assumed dose-toxicity curves. A necessary component of the evaluation process is to have some concept for how well a design can possibly perform. The notion of an upper bound on the accuracy of maximum tolerated dose selection is often omitted from the simulation study, and the aim of this work is to provide researchers with accessible software to quickly evaluate the operating characteristics of Phase I methods using a benchmark...
June 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28641461/the-impact-of-data-errors-on-the-outcome-of-randomized-clinical-trials
#8
Marc Buyse, Pierre Squifflet, Elisabeth Coart, Emmanuel Quinaux, Cornelis Ja Punt, Everardo D Saad
Background/aims Considerable human and financial resources are typically spent to ensure that data collected for clinical trials are free from errors. We investigated the impact of random and systematic errors on the outcome of randomized clinical trials. Methods We used individual patient data relating to response endpoints of interest in two published randomized clinical trials, one in ophthalmology and one in oncology. These randomized clinical trials enrolled 1186 patients with age-related macular degeneration and 736 patients with metastatic colorectal cancer...
June 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28627929/design-of-the-hptn-065-tlc-plus-study-a-study-to-evaluate-the-feasibility-of-an-enhanced-test-link-to-care-plus-treat-approach-for-hiv-prevention-in-the-united-states
#9
Theresa Gamble, Bernard Branson, Deborah Donnell, H Irene Hall, Georgette King, Blayne Cutler, Shannon Hader, David Burns, Jason Leider, Angela Fulwood Wood, Kevin G Volpp, Kate Buchacz, Wafaa M El-Sadr
Background/Aims HIV continues to be a major public health threat in the United States, and mathematical modeling has demonstrated that the universal effective use of antiretroviral therapy among all HIV-positive individuals (i.e. the "test and treat" approach) has the potential to control HIV. However, to accomplish this, all the steps that define the HIV care continuum must be achieved at high levels, including HIV testing and diagnosis, linkage to and retention in clinical care, antiretroviral medication initiation, and adherence to achieve and maintain viral suppression...
June 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28622753/re-randomization-tests-for-unplanned-changes-in-clinical-trials
#10
Michael A Proschan
Despite the best efforts of investigators, problems forcing design changes can occur in clinical trials. Changes are usually relatively minor, but sometimes not. The primary endpoint or analysis may need to be revised, for example. It is common to regard any conclusion from such a tarnished trial as hypothesis-generating rather than definitive. This article reviews a very useful technique, re-randomization tests, for dealing with such anomalies. Re-randomization tests remain valid for testing a strong null hypothesis that treatment has no effect on the data that led to design changes...
June 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28532202/experiences-of-establishing-an-academic-early-phase-clinical-trials-unit
#11
Sarah R Brown, Debbie Sherratt, Gill Booth, Julia Brown, Fiona Collinson, Walter Gregory, Louise Flanagan
BACKGROUND: Early phase trials are essential in drug development, determining appropriate dose levels and assessing preliminary activity. These trials are undertaken by industry and academia, with increasing collaborations between the two. There is pressure to perform these trials quickly, safely, and robustly. However, there are inherent differences between developing and managing early phase, compared to late phase, drug trials. This article describes an approach to establishing an academically led early phase trial portfolio, highlighting lessons learned and sharing experiences...
May 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28532162/commentary-on-mason-et-al
#12
Daniel F Heitjan
No abstract text is available yet for this article.
May 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28503947/recommendations-for-data-monitoring-committees-from-the-clinical-trials-transformation-initiative
#13
Karim A Calis, Patrick Archdeacon, Raymond Bain, David DeMets, Miriam Donohue, M Khair Elzarrad, Annemarie Forrest, John McEachern, Michael J Pencina, Jane Perlmutter, Roger J Lewis
Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and conduct. To understand and describe the role and function of data monitoring committees, and establish best practices for data monitoring committee trial oversight, the Clinical Trials Transformation Initiative-a public-private partnership to improve clinical trials-launched a multi-stakeholder project...
May 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28486851/structure-to-utilize-interventionists-implementation-experiences-of-a-family-based-behavioral-weight-management-program-to-enhance-the-dissemination-of-the-standardized-intervention-the-today-study
#14
Jennifer Q Chadwick, Dorothy J Van Buren, Elisa Morales, Alexandra Timpson, Ericka L Abrams, Amy Syme, Jeff Preske, Gerardo Mireles, Barbara Anderson, Nisha Grover, Lori Laffel
Background For a 2- to 6-year period, interventionists for the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) randomized clinical trial delivered a family-based, behavioral weight-loss program (the TODAY Lifestyle Program) to 234 youth with type 2 diabetes. Interventionists held at least a bachelor's degree in psychology, social work, education, or health-related field and had experience working with children and families, especially from diverse ethnic and socioeconomic backgrounds...
May 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28545337/evaluation-of-different-recall-periods-for-the-us-national-cancer-institute-s-pro-ctcae
#15
Tito R Mendoza, Amylou C Dueck, Antonia V Bennett, Sandra A Mitchell, Bryce B Reeve, Thomas M Atkinson, Yuelin Li, Kathleen M Castro, Andrea Denicoff, Lauren J Rogak, Richard L Piekarz, Charles S Cleeland, Jeff A Sloan, Deborah Schrag, Ethan Basch
AIMS: The US National Cancer Institute recently developed the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events). PRO-CTCAE is a library of questions for clinical trial participants to self-report symptomatic adverse events (e.g. nausea). The objective of this study is to inform evidence-based selection of a recall period when PRO-CTCAE is included in a trial. We evaluated differences between 1-, 2-, 3-, and 4-week recall periods, using daily reporting as the reference...
June 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28545336/design-of-a-cluster-randomized-minority-recruitment-trial-recruit
#16
Barbara C Tilley, Arch G Mainous, Daniel W Smith, M Diane McKee, Rossybelle P Amorrortu, Jennifer Alvidrez, Vanessa Diaz, Marvella E Ford, Maria E Fernandez, Robert A Hauser, Carlos Singer, Veronica Landa, Aron Trevino, Stacia M DeSantis, Yefei Zhang, Elvan Daniels, Derrick Tabor, Sally W Vernon
BACKGROUND: Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups...
June 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28545335/controlling-the-family-wise-error-rate-in-multi-arm-multi-stage-trials
#17
Luis A Crouch, Lori E Dodd, Michael A Proschan
BACKGROUND AND AIMS: Multi-arm, multi-stage trials have recently gained attention as a means to improve the efficiency of the clinical trials process. Many designs have been proposed, but few explicitly consider the inherent issue of multiplicity and the associated type I error rate inflation. It is our aim to propose a straightforward design that controls family-wise error rate while still providing improved efficiency. METHODS: In this article, we provide an analytical method for calculating the family-wise error rate for a multi-arm, multi-stage trial and highlight the potential for considerable error rate inflation in uncontrolled designs...
June 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28135830/a-randomized-trial-of-heart-failure-disease-management-in-skilled-nursing-facilities-snf-connect-lessons-learned
#18
Andrea Daddato, Heidi L Wald, Carolyn Horney, Diane L Fairclough, Erin C Leister, Marilyn Coors, Warren H Capell, Rebecca S Boxer
BACKGROUND/AIMS: Conducting clinical trials in skilled nursing facilities is particularly challenging. This manuscript describes facility and patient recruitment challenges and solutions for clinical research in skilled nursing facilities. METHODS: Lessons learned from the SNF Connect Trial, a randomized trial of a heart failure disease management versus usual care for patients with heart failure receiving post-acute care in skilled nursing facilities, are discussed...
June 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28135827/a-conceptual-model-for-the-development-process-of-confirmatory-adaptive-clinical-trials-within-an-emergency-research-network
#19
Samkeliso C Mawocha, Michael D Fetters, Laurie J Legocki, Timothy C Guetterman, Shirley Frederiksen, William G Barsan, Roger J Lewis, Donald A Berry, William J Meurer
BACKGROUND: Adaptive clinical trials use accumulating data from enrolled subjects to alter trial conduct in pre-specified ways based on quantitative decision rules. In this research, we sought to characterize the perspectives of key stakeholders during the development process of confirmatory-phase adaptive clinical trials within an emergency clinical trials network and to build a model to guide future development of adaptive clinical trials. METHODS: We used an ethnographic, qualitative approach to evaluate key stakeholders' views about the adaptive clinical trial development process...
June 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28135804/the-interaction-between-equipoise-and-logistics-in-clinical-trials-a-case-study
#20
Meredith G Warshaw, Vincent J Carey, Elizabeth J McFarland, Liza Dawson, Elaine Abrams, Ann Melvin, Lee Fairlie, Hans Spiegel, Jonathan Jay, Allison L Agwu
INTRODUCTION: Equipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications. BACKGROUND: Clinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials...
June 2017: Clinical Trials: Journal of the Society for Clinical Trials
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