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Clinical Trials: Journal of the Society for Clinical Trials

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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
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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/28452236/mobile-access-to-virtual-randomization-for-investigator-initiated-trials
#7
Thomas M Deserno, András P Keszei
Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand...
April 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28393632/increasing-response-rates-to-follow-up-questionnaires-in-health-intervention-research-randomized-controlled-trial-of-a-gift-card-prize-incentive
#8
Amy J Morgan, Ronald M Rapee, Jordana K Bayer
Background/aims Achieving a high response rate to follow-up questionnaires in randomized controlled trials of interventions is important for study validity. Few studies have tested the value of incentives in increasing response rates to online questionnaires in clinical trials of health interventions. This study evaluated the effect of a gift card prize-draw incentive on response rates to follow-up questionnaires within a trial of an online health intervention. Method The study was embedded in a host randomized controlled trial of an online parenting program for child anxiety...
April 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28393537/inadequacy-of-ethical-conduct-and-reporting-of-stepped-wedge-cluster-randomized-trials-results-from-a-systematic-review
#9
Monica Taljaard, Karla Hemming, Lena Shah, Bruno Giraudeau, Jeremy M Grimshaw, Charles Weijer
Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting...
April 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28385071/treatment-of-missing-data-in-follow-up-studies-of-randomised-controlled-trials-a-systematic-review-of-the-literature
#10
Thomas R Sullivan, Lisa N Yelland, Katherine J Lee, Philip Ryan, Amy B Salter
BACKGROUND/AIMS: After completion of a randomised controlled trial, an extended follow-up period may be initiated to learn about longer term impacts of the intervention. Since extended follow-up studies often involve additional eligibility restrictions and consent processes for participation, and a longer duration of follow-up entails a greater risk of participant attrition, missing data can be a considerable threat in this setting. As a potential source of bias, it is critical that missing data are appropriately handled in the statistical analysis, yet little is known about the treatment of missing data in extended follow-up studies...
April 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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
https://www.readbyqxmd.com/read/28068834/design-considerations-of-a-randomized-controlled-trial-of-sedation-level-during-hip-fracture-repair-surgery-a-strategy-to-reduce-the-incidence-of-postoperative-delirium-in-elderly-patients
#17
Tianjing Li, L Susan Wieland, Esther Oh, Karin J Neufeld, Nae-Yuh Wang, Kay Dickersin, Frederick E Sieber
Background Delirium is an acute change in mental status characterized by sudden onset, fluctuating course, inattention, disorganized thinking, and abnormal level of consciousness. The objective of the randomized controlled trial "A STrategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients" (STRIDE) is to assess the effectiveness of light versus heavy sedation on delirium and other outcomes in elderly patients undergoing hip fracture repair surgery. Our goal is to describe the design considerations and lessons learned in planning and implementing the STRIDE trial...
June 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28359194/data-monitoring-committees-promoting-best-practices-to-address-emerging-challenges
#18
Thomas R Fleming, David L DeMets, Matthew T Roe, Janet Wittes, Karim A Calis, Amit N Vora, Alan Meisel, Raymond P Bain, Marvin A Konstam, Michael J Pencina, David J Gordon, Kenneth W Mahaffey, Charles H Hennekens, James D Neaton, Gail D Pearson, Tomas Lg Andersson, Marc A Pfeffer, Susan S Ellenberg
BACKGROUND AND PURPOSE: Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials. The independence of data monitoring committees from sponsors and investigators is essential in achieving this mission. Creative approaches are needed to address ongoing and emerging challenges that potentially threaten data monitoring committees' independence and effectiveness. METHODS: An expert panel of representatives from academia, industry and government sponsors, and regulatory agencies discussed these challenges and proposed best practices and operating principles for effective functioning of contemporary data monitoring committees...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28359193/corrigendum
#19
(no author information available yet)
No abstract text is available yet for this article.
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28359192/impact-of-individual-clinical-outcomes-on-trial-participants-perspectives-on-enrollment-in-emergency-research-without-consent
#20
Louisa W Whitesides, Jill M Baren, Michelle H Biros, Ross J Fleischman, Prasanthi R Govindarajan, Elizabeth B Jones, Arthur M Pancioli, Rebecca D Pentz, Victoria M Scicluna, David W Wright, Neal W Dickert
BACKGROUND: Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. METHODS: Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
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