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Clinical Trials: Journal of the Society for Clinical Trials

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https://www.readbyqxmd.com/read/30230365/patient-reported-outcomes-version-of-the-common-terminology-criteria-for-adverse-events-methods-for-item-selection-in-industry-sponsored-oncology-clinical-trials
#1
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
https://www.readbyqxmd.com/read/30165760/development-of-an-online-resource-for-recruitment-research-in-clinical-trials-to-organise-and-map-current-literature
#2
Anna Kearney, Nicola L Harman, Anna Rosala-Hallas, Claire Beecher, Jane M Blazeby, Peter Bower, Mike Clarke, William Cragg, Sinead Dune, 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
https://www.readbyqxmd.com/read/30156433/contingency-management-intervention-targeting-co-addiction-of-alcohol-and-drugs-among-american-indian-adults-design-methodology-and-baseline-data
#3
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. Contingency management is a behavioral intervention designed to increase drug abstinence by offering monetary incentives in exchange for drug and alcohol negative urine samples...
August 29, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/30141714/moving-forward-toward-standardizing-analysis-of-quality-of-life-data-in-randomized-cancer-clinical-trials
#4
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
https://www.readbyqxmd.com/read/30132361/triggered-or-routine-site-monitoring-visits-for-randomised-controlled-trials-results-of-temper-a-prospective-matched-pair-study
#5
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
https://www.readbyqxmd.com/read/30101615/recruitment-and-retention-of-the-hardest-to-reach-families-in-community-based-asthma-interventions
#6
Hillary Goldman, Maria Fagnano, Tamara T Perry, Ariel Weisman, Amanda Drobnica, Jill S Halterman
Background/Aims Engaging underserved populations in research requires substantial effort for recruitment and retention. The objective of this study is to describe the effort needed to recruit and retain urban participants in pediatric asthma studies and to characterize the Hardest-to-Reach group by demographics and asthma severity. Methods We included 311 children (3-10 years) with persistent asthma enrolled in two school-based asthma interventions in Rochester, NY. Contact logs were collected at four time points (baseline, 2 month, 4 month, 6 month)...
August 13, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/30074410/comparing-two-methods-for-delivering-clinical-trial-informed-consent-information-to-older-adults-singular-versus-stepped-approach
#7
Fleur O'Hare, Zachary Flanagan, Mark Nelson, Andrea Curtis, Stephane Heritier, Simone Spark, Sophia Zoungas
Background Adapting the informed consent process to the needs of older adults may enhance engagement and willingness to participate in a clinical trial. A key aspect of the process is being provided with written clinical trial information and consent documents and having an opportunity to discuss the information with the researcher. However, there are no guidelines on the most appropriate method for delivering this information to older adults and it is not known whether the delivery method is a facilitator or barrier towards clinical trial participation...
August 3, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/30204025/beyond-p-values-a-phase-ii-dual-criterion-design-with-statistical-significance-and-clinical-relevance
#8
Satrajit Roychoudhury, Nicolas Scheuer, Beat Neuenschwander
Background Well-designed phase II trials must have acceptable error rates relative to a pre-specified success criterion, usually a statistically significant p-value. Such standard designs may not always suffice from a clinical perspective because clinical relevance may call for more. For example, proof-of-concept in phase II often requires not only statistical significance but also a sufficiently large effect estimate. Purpose We propose dual-criterion designs to complement statistical significance with clinical relevance, discuss their methodology, and illustrate their implementation in phase II...
October 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/30101616/revisiting-isotonic-phase-i-design-in-the-era-of-model-assisted-dose-finding
#9
Nolan A Wages, Mark R Conaway
Background/aims In the conduct of phase I trials, the limited use of innovative model-based designs in practice has led to an introduction of a class of "model-assisted" designs with the aim of effectively balancing the trade-off between design simplicity and performance. Prior to the recent surge of these designs, methods that allocated patients to doses based on isotonic toxicity probability estimates were proposed. Like model-assisted methods, isotonic designs allow investigators to avoid difficulties associated with pre-trial parametric specifications of model-based designs...
October 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/30084662/performance-and-predictors-of-recruitment-success-in-national-heart-lung-and-blood-institute-s-cardiovascular-clinical-trials
#10
Victoria L Pemberton, Frank Evans, Jamie Gulin, Ellen Rosenberg, Ebyan Addou, Kristin M Burns, David J Gordon, Gail D Pearson, Jonathan R Kaltman
Background/Aims Identifying predictors of recruitment success in clinical trials, particularly prior to study launch, could contribute to higher study completion rates and improved scientific return on investment. This article evaluates the performance of clinical trials funded by the National Heart, Lung, and Blood Institute that began recruitment before and after implementation of National Heart, Lung, and Blood Institute's 2009 Accrual Policy and identifies study-related factors that predict recruitment success...
October 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/30074407/design-of-non-inferiority-randomized-trials-using-the-difference-in-restricted-mean-survival-times
#11
Isabelle R Weir, Ludovic Trinquart
Background/aims Non-inferiority trials with time-to-event outcomes are becoming increasingly common. Designing non-inferiority trials is challenging, in particular, they require very large sample sizes. We hypothesized that the difference in restricted mean survival time, an alternative to the hazard ratio, could lead to smaller required sample sizes. Methods We show how to convert a margin for the hazard ratio into a margin for the difference in restricted mean survival time and how to calculate the required sample size under a Weibull survival distribution...
October 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/30070143/the-ethics-of-uninsured-participants-accessing-healthcare-in-biomedical-research-a-literature-review
#12
Hae Lin Cho, Marion Danis, Christine Grady
Background/aims Sparse literature exists on the challenges and ethical considerations of including people with limited access to healthcare, such as the uninsured and low-income, in clinical research in high-income countries. However, many ethical issues should be considered with respect to working with uninsured and low-income participants in clinical research, including enrollment and retention, ancillary care, and post-trial responsibilities. Attention to the uninsured and low-income is particularly salient in the United States due to the high rates of uninsurance and underinsurance...
October 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/30035644/application-of-multi-state-models-in-cancer-clinical-trials
#13
Jennifer G Le-Rademacher, Ryan A Peterson, Terry M Therneau, Ben L Sanford, Richard M Stone, Sumithra J Mandrekar
Background/aims The goal of this article is to illustrate the utility of multi-state models in cancer clinical trials. Our specific aims are to describe multi-state models and how they differ from standard survival methods, to illustrate how multi-state models can facilitate deeper understanding of the treatment effect on multiple paths along the disease process that patients could experience in cancer clinical trials, to explain the differences between multi-state models and time-dependent Cox models, and to briefly describe available software to conduct such analyses...
October 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29952243/e-recruitment-into-a-bipolar-disorder-trial-using-facebook-tailored-advertising
#14
Marco D Huesch, Dahlia Mukherjee, Erika Fh Saunders
No abstract text is available yet for this article.
October 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29895178/ebovac-salone-lessons-learned-from-implementing-an-ebola-vaccine-trial-in-an-ebola-affected-country
#15
Thomas Mooney, Elizabeth Smout, Bailah Leigh, Brian Greenwood, Luisa Enria, David Ishola, Daniela Manno, Mohamed Samai, Macaya Douoguih, Deborah Watson-Jones
Background/aims During the 2014-2016 West African Ebola epidemic, clinical trials were fast-tracked in order to identify prophylactic vaccines and experimental treatments that might be useful in preventing or treating Ebola. These trials included the ongoing EBOVAC-Salone study, which was established and implemented in Sierra Leone to assess the safety and immunogenicity of the Ad26.ZEBOV/MVA-BN-Filo prime-boost Ebola vaccine regimen. Methods This article describes the experiences of the EBOVAC-Salone research team in setting up and implementing the trial, and provides recommendations for research teams aiming to conduct clinical trials in future outbreak situations...
October 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29871495/rethinking-non-inferiority-a-practical-trial-design-for-optimising-treatment-duration
#16
Matteo Quartagno, A Sarah Walker, James R Carpenter, Patrick Pj Phillips, Mahesh Kb Parmar
Background Trials to identify the minimal effective treatment duration are needed in different therapeutic areas, including bacterial infections, tuberculosis and hepatitis C. However, standard non-inferiority designs have several limitations, including arbitrariness of non-inferiority margins, choice of research arms and very large sample sizes. Methods We recast the problem of finding an appropriate non-inferior treatment duration in terms of modelling the entire duration-response curve within a pre-specified range...
October 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29865904/double-blind-trials-in-hyperbaric-medicine-a-narrative-review-on-past-experiences-and-considerations-in-designing-sham-hyperbaric-treatment
#17
Nina Ca Lansdorp, Rob A van Hulst
Background Hyperbaric oxygen therapy, which consists of breathing 100% oxygen under a higher atmospheric pressure than normal, is utilized worldwide in the treatment of several diseases. With the growing demand for evidence-based research, hyperbaric oxygen therapy has been criticized for delivering too little high-quality research, mainly in the form of randomized controlled trials. While not always indispensable, the addition of a sham-controlled group to such a trial can contribute to the quality of the research...
October 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29792074/lessons-learned-conducting-a-multi-center-trial-with-a-military-population-the-tinnitus-retraining-therapy-trial
#18
Roberta W Scherer, Leonora D Sensinger, Benigno Sierra-Irizarry, Craig Formby
Background The Tinnitus Retraining Therapy Trial (TRTT), a randomized, placebo-controlled, multi-center trial, evaluated the efficacy of tinnitus retraining therapy and its individual components, tinnitus-specific educational counseling and sound therapy versus the standard of care, in military practice to improve study participants' quality of life. The trial was conducted at six US military hospitals to take advantage of the greater prevalence of tinnitus in the military population. Methods During the trial, various challenges arose that were uniquely related to the military setting...
October 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/30129779/abstracts-from-the-sct-39th-annual-meeting-2018
#19
(no author information available yet)
No abstract text is available yet for this article.
August 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/30021497/university-of-pennsylvania-10th-annual-conference-on-statistical-issues-in-clinical-trials-current-issues-regarding-data-and-safety-monitoring-committees-in-clinical-trials-afternoon-panel-session
#20
Kay Dickersin, Dennis Dixon, Frederick Ferris, Judith Goldberg, Stephen Kimmel, John Lachin
No abstract text is available yet for this article.
August 2018: Clinical Trials: Journal of the Society for Clinical Trials
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