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Clinical Trials: Journal of the Society for Clinical Trials

Seung Yeon Song, Deborah Chee, EunYoung Kim
BACKGROUND: With the recent publication of the International Conference on Harmonisation E17 guideline and major reforms in China underway, the platform for clinical trial conduct is expected to change. This study aims to assess the strategic inclusion of regions in clinical trials and its change in trends over the past decade. METHODS: The registry was searched for clinical trials registered by the top 10 pharmaceutical companies between 1 January 2008 and 31 December 2017...
November 16, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Zhiwei Zhang, Linli Tang, Chunling Liu, Vance W Berger
BACKGROUND: Baseline covariate imbalance (between treatment groups) is a common problem in randomized clinical trials which often raises questions about the validity of trial results. Answering these questions requires careful consideration of the statistical implications of covariate imbalance. The possibil ity of having covariate imbalance contributes to the marginal variance of an unadjusted treatment difference estimator, which can be reduced by making appropriate adjustments. Actual observed imbalance introduces a conditional bias into an unadjusted estimator, which may increase the conditional size of an unadjusted test...
November 16, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Jodie Allen, Abbey Child, Sarah Mertens
OBJECTIVE: To develop an end-to-end clinical trial service to improve patient experience during trials, reduce the burden of participating in a trial, and increase trial retention. METHODS: A literature search and stakeholder interviews were used to identify current challenges and unmet needs of systemic lupus erythematosus patients and other systemic lupus erythematosus clinical trial stakeholders. The results from the literature search and interviews were used to create a five-phase map describing the current clinical trial experience of all stakeholders...
November 14, 2018: Clinical Trials: Journal of the Society for Clinical Trials
James F Casella, Robert J Adams, Donald J Brambilla, John J Strouse, Pia Maier, Rachel Dlugash, Radhika Avadhani, Krista Vermillion, James Tonascia, Jenifer H Voeks, Daniel F Hanley, Richard E Thompson, Harold P Lehmann
BACKGROUND: Studies of interventions to prevent the many neurological complications of sickle cell disease must take into account multiple outcomes of variable severity, with limited sample size. The goals of the studies presented were to use investigator preferences across outcomes to determine an attitude-based weighting of relevant clinical outcomes and to establish a valid composite outcome for a clinical trial. METHODS: In Study 1, investigators were surveyed about their practice regarding hydroxyurea therapy and opinions about outcomes for the "Hydroxyurea to Prevent the Central Nervous System Complications of Sickle Cell Disease Trial" (HU Prevent), and their minimally acceptable relative risk reduction for the two outcome components, motor and neurocognitive deficits...
November 14, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Michael P Diamond, Esther Eisenberg, Hao Huang, Christos Coutifaris, Richard S Legro, Karl R Hansen, Anne Z Steiner, Marcelle Cedars, Kurt Barnhart, Tracy Ziolek, Tracey R Thomas, Kate Maurer, Stephen A Krawetz, Robert A Wild, J C Trussell, Nanette Santoro, Heping Zhang
BACKGROUND/AIMS: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. METHODS: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites...
October 24, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Haidong Lu, Stephen R Cole, H Irene Hall, Enrique F Schisterman, Tiffany L Breger, Jessie K Edwards, Daniel Westreich
Background Intention-to-treat comparisons of randomized trials provide asymptotically consistent estimators of the effect of treatment assignment, without regard to compliance. However, decision makers often wish to know the effect of a per-protocol comparison. Moreover, decision makers may also wish to know the effect of treatment assignment or treatment protocol in a user-specified target population other than the sample in which the trial was fielded. Here, we aimed to generalize results from the ACTG A5095 trial to the US recently HIV-diagnosed target population...
October 17, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Rick Chappell
No abstract text is available yet for this article.
October 13, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Bethany Jablonski Horton, Nolan A Wages, Mark R Conaway
Background Limited options are available for dose-finding clinical trials requiring group-specific dose selection. While conducting parallel trials for groups is an accessible approach to group-specific dose selection, this approach allows for maximum tolerated dose selection that does not align with clinically meaningful group order information. Methods The two-stage continual reassessment method is developed for dose-finding in studies involving three or more groups where group frailty order is known between some but not all groups, creating a partial order...
October 11, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Philip M Westgate
Background/aims Cluster randomized trials are popular in health-related research due to the need or desire to randomize clusters of subjects to different trial arms as opposed to randomizing each subject individually. As outcomes from subjects within the same cluster tend to be more alike than outcomes from subjects within other clusters, an exchangeable correlation arises that is measured via the intra-cluster correlation coefficient. Intra-cluster correlation coefficient estimation is especially important due to the increasing awareness of the need to publish such values from studies in order to help guide the design of future cluster randomized trials...
October 8, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Francis X Baker, Jon F Merz
Waivers of informed consent for research participation are permitted in the United States under the Common Rule, the Health Insurance Portability and Accountability Act regulations, and the US Food and Drug Administration's Exception from Informed Consent rule for emergency research. We assess the novel question regarding what legal right researchers have to carry out research procedures on or about another person, be it experimental medical intervention, psychological or social manipulation, or invasion of privacy, without the permission of their subjects...
October 3, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Ajay Singh, Ken Twomey, Robert Baker
No abstract text is available yet for this article.
September 29, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Miles D Witham, Margaret M Band, Rosemary J G Price, Roberta L Fulton, Clare L Clarke, Peter T Donnan, Roy L Soiza, Vera Cvoro
Background/Aims Recruitment to trials of intervention for older people who fall is challenging. Evidence suggests that the word falls has negative connotations for older people, and this may present a barrier to engaging with trials in this area. We therefore tested whether a participant information sheet that minimised reference to falls could improve recruitment rates. Methods We conducted a study within a trial, embedded within a randomised controlled trial of vitamin K versus placebo to improve postural sway in patients aged 65 and over with a history of falls...
September 27, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Peter C Trask, Amylou C Dueck, Elisabeth Piault, Alicyn Campbell
As new cancer treatment regimens demonstrate increased potential to improve patients' survival, more focus is directed toward the quality of that extension of life and to obtaining additional information from patients regarding their experience with treatment. The utility of capturing patient-reported treatment-related symptoms to complement traditional clinician-rated symptomatic adverse event reporting is well-documented. The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library aimed at capturing patient-reported symptoms to inform the patient perspective on a treatment's tolerability...
September 19, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Anna Kearney, Nicola L Harman, Anna Rosala-Hallas, Claire Beecher, Jane M Blazeby, Peter Bower, Mike Clarke, William Cragg, Sinead Duane, Heidi Gardner, Patricia Healy, Lisa Maguire, Nicola Mills, Leila Rooshenas, Ceri Rowlands, Shaun Treweek, Akke Vellinga, Paula R Williamson, Carrol Gamble
Background Recruiting the target number of participants within the pre-specified time frame agreed with funders remains a common challenge in the completion of a successful clinical trial and addressing this is an important methodological priority. While there is growing research around recruitment, navigating this literature to support an evidence-based approach remains difficult. The Online resource for Recruitment Research in Clinical triAls project aims to create an online searchable database of recruitment research to improve access to existing evidence and to identify gaps for future research...
August 31, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Andrew Bottomley, Madeline Pe, Jeff Sloan, Ethan Basch, Franck Bonnetain, Melanie Calvert, Alicyn Campbell, Charles Cleeland, Kim Cocks, Laurence Collette, Amylou C Dueck, Nancy Devlin, Hans-Henning Flechtner, Carolyn Gotay, Eva Greimel, Ingolf Griebsch, Mogens Groenvold, Jean-Francois Hamel, Madeleine King, Paul G Kluetz, Michael Koller, Daniel C Malone, Francesca Martinelli, Sandra A Mitchell, Carol M Moinpour, Jammbe Z Musoro, Daniel O'Connor, Kathy Oliver, Elisabeth Piault-Louis, Martine Piccart, Francisco L Pimentel, Chantal Quinten, Jaap C Reijneveld, Christoph Schürmann, Ashley Wilder Smith, Katherine M Soltys, Rajeshwari Sridhara, Martin J B Taphoorn, Galina Velikova, Corneel Coens
Background There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs...
August 24, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Sally P Stenning, William J Cragg, Nicola Joffe, Carlos Diaz-Montana, Rahela Choudhury, Matthew R Sydes, Sarah Meredith
Background/aims In multi-site clinical trials, where trial data and conduct are scrutinised centrally with pre-specified triggers for visits to sites, targeted monitoring may be an efficient way to prioritise on-site monitoring. This approach is widely used in academic trials, but has never been formally evaluated. Methods TEMPER assessed the ability of targeted monitoring, as used in three ongoing phase III randomised multi-site oncology trials, to distinguish sites at which higher and lower rates of protocol and/or Good Clinical Practice violations would be found during site visits...
August 22, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Kathleen Marie Brelsford, Ernesto Ruiz, Laura Beskow
BACKGROUND/AIMS: An increasing body of research is being conducted with non-English-speaking subjects. Study-related materials, including those essential for obtaining informed consent, must often be translated from English into other languages. In this study, we sought to examine the types of issues that may arise when consent materials are translated from English to Spanish. METHODS: Drawing on expertise from five individuals associated with our research team, four of whom are native Spanish speakers of different dialects of Spanish, we crafted translations of our own consent materials for biobanking using a rigorous, multi-step process involving both forward and back translation...
December 2018: Clinical Trials: Journal of the Society for Clinical Trials
Neal W Dickert, David Wendler, Chandan M Devireddy, Sara F Goldkind, Yi-An Ko, Candace D Speight, Scott Yh Kim
BACKGROUND: There has been debate about the role of consent in pragmatic trials comparing qualitatively similar interventions. Consent preferences may differ in acute care contexts, given severe illness, time constraints, and other barriers to consent. In addition, studies have not assessed the impact of disclosing financial considerations as a justification for trials. This study was designed to assess preferences of the general public regarding consent for a pragmatic trial in ST-elevation myocardial infarction...
December 2018: Clinical Trials: Journal of the Society for Clinical Trials
Ekaterina Burduli, Jordan Skalisky, Katherine Hirchak, Michael F Orr, Albert Foote, Alexandria Granbois, Richard Ries, John M Roll, Dedra Buchwald, Michael G McDonell, Sterling M McPherson
BACKGROUND/AIMS: American Indian adults have some of the highest alcohol abstinence rates compared to the overall US population. Despite this, many American Indian people are more likely to concurrently use alcohol and illicit drugs and are less likely to participate and remain in outpatient treatment for alcohol and other drug use compared to the general US population. There is limited knowledge about effective interventions targeting alcohol and drug co-addiction among American Indian adults...
December 2018: Clinical Trials: Journal of the Society for Clinical Trials
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