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Clinical Trials: Journal of the Society for Clinical Trials

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https://www.readbyqxmd.com/read/29952243/e-recruitment-into-a-bipolar-disorder-trial-using-facebook-tailored-advertising
#1
Marco D Huesch, Dahlia Mukherjee, Erika Fh Saunders
No abstract text is available yet for this article.
June 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29932002/proceedings-of-the-university-of-pennsylvania-10th-annual-conference-on-statistical-issues-in-clinical-trials-current-issues-regarding-data-and-safety-monitoring-committees-in-clinical-trials
#2
Susan S Ellenberg, Jonas H Ellenberg
No abstract text is available yet for this article.
June 1, 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
#3
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...
June 1, 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
#4
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...
June 1, 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
#5
C A 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...
June 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29865897/incidence-and-impact-of-withdrawal-of-life-sustaining-therapies-in-clinical-trials-of-severe-traumatic-brain-injury-a-systematic-review
#6
Guillaume Leblanc, Amélie Boutin, Michèle Shemilt, François Lauzier, Lynne Moore, Véronique Potvin, Ryan Zarychanski, Patrick Archambault, François Lamontagne, Caroline Léger, Alexis F Turgeon
Background Most deaths following severe traumatic brain injury follow decisions to withdraw life-sustaining therapies. However, the incidence of the withdrawal of life-sustaining therapies and its potential impact on research data interpretation have been poorly characterized. The aim of this systematic review was to assess the reporting and the impact of withdrawal of life-sustaining therapies in randomized clinical trials of patients with severe traumatic brain injury. Methods We searched Medline, Embase, Cochrane Central, BIOSIS, and CINAHL databases and references of included trials...
June 1, 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
#7
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...
May 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29779418/modeling-adverse-event-counts-in-phase-i-clinical-trials-of-a-cytotoxic-agent
#8
Daniel G Muenz, Thomas M Braun, Jeremy Mg Taylor
Background/Aims The goal of phase I clinical trials for cytotoxic agents is to find the maximum dose with an acceptable risk of severe toxicity. The most common designs for these dose-finding trials use a binary outcome indicating whether a patient had a dose-limiting toxicity. However, a patient may experience multiple toxicities, with each toxicity assigned an ordinal severity score. The binary response is then obtained by dichotomizing a patient's richer set of data. We contribute to the growing literature on new models to exploit this richer toxicity data, with the goal of improving the efficiency in estimating the maximum tolerated dose...
May 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29741390/the-independent-statistician-model-how-well-is-it-working
#9
David DeMets
With the initiation in the late 1960s of the data and safety monitoring board or equivalently the data monitoring committee in randomized clinical trials came the need for interim statistical reports for these committees to review for study conduct and early evidence of harm or overwhelming evidence of benefit, perhaps leading to early trial termination. Initially, the statistical team was part of the data coordinating center for the trial. Later, starting in the early 1990s in many industry-sponsored trials, this statistical unit was separated organizationally from the team that collected and managed the data...
May 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29871509/the-us-food-and-drug-administration-s-expedited-approval-programs-evidentiary-standards-regulatory-trade-offs-and-potential-improvements
#10
Joshua D Wallach, Joseph S Ross, Huseyin Naci
The US Food and Drug Administration has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs is the regulatory flexibility, which allows for a customized approval approach that enables market authorization on the basis of less rigorous evidence, in exchange for requiring postmarket evidence generation. An increasing share of therapeutic agents approved by the Food and Drug Administration in recent years are associated with expedited programs...
June 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29871508/expediting-drug-development-for-serious-illness-trade-offs-between-patient-access-and-certainty
#11
Janet Woodcock
No abstract text is available yet for this article.
June 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29871507/the-us-food-and-drug-administration-s-expedited-approval-programs-addressing-premarket-flexibility-with-enhanced-postmarket-evidence-generation
#12
Joshua D Wallach, Joseph S Ross, Huseyin Naci
No abstract text is available yet for this article.
June 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29871506/expedited-approval-programs-at-the-food-and-drug-administration
#13
Colin B Begg, Susan S Ellenberg
No abstract text is available yet for this article.
June 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29871505/expedited-and-facilitated-drug-evaluations-and-evidence-of-benefit-and-risk-the-cup-is-half-full
#14
Robert M Califf
No abstract text is available yet for this article.
June 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29871504/access-versus-evidence-the-regulators-dilemma
#15
Richard L Schilsky
No abstract text is available yet for this article.
June 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29671345/a-new-modeling-and-inference-approach-for-the-systolic-blood-pressure-intervention-trial-outcomes
#16
Song Yang, Walter T Ambrosius, Lawrence J Fine, Adam P Bress, William C Cushman, Dominic S Raj, Shakaib Rehman, Leonardo Tamariz
Background/aims In clinical trials with time-to-event outcomes, usually the significance tests and confidence intervals are based on a proportional hazards model. Thus, the temporal pattern of the treatment effect is not directly considered. This could be problematic if the proportional hazards assumption is violated, as such violation could impact both interim and final estimates of the treatment effect. Methods We describe the application of inference procedures developed recently in the literature for time-to-event outcomes when the treatment effect may or may not be time-dependent...
June 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29638145/prevalence-and-reporting-of-recruitment-randomisation-and-treatment-errors-in-clinical-trials-a-systematic-review
#17
Lisa N Yelland, Brennan C Kahan, Elsa Dent, Katherine J Lee, Merryn Voysey, Andrew B Forbes, Jonathan A Cook
Background/aims In clinical trials, it is not unusual for errors to occur during the process of recruiting, randomising and providing treatment to participants. For example, an ineligible participant may inadvertently be randomised, a participant may be randomised in the incorrect stratum, a participant may be randomised multiple times when only a single randomisation is permitted or the incorrect treatment may inadvertently be issued to a participant at randomisation. Such errors have the potential to introduce bias into treatment effect estimates and affect the validity of the trial, yet there is little motivation for researchers to report these errors and it is unclear how often they occur...
June 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29608096/reporting-non-adherence-in-cluster-randomised-trials-a-systematic-review
#18
Schadrac C Agbla, Karla DiazOrdaz
BACKGROUND: Treatment non-adherence in randomised trials refers to situations where some participants do not receive their allocated treatment as intended. For cluster randomised trials, where the unit of randomisation is a group of participants, non-adherence may occur at the cluster or individual level. When non-adherence occurs, randomisation no longer guarantees that the relationship between treatment receipt and outcome is unconfounded, and the power to detect the treatment effects in intention-to-treat analysis may be reduced...
June 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29577741/liberti-a-smart-study-in-plastic-surgery
#19
Jonathan C Hibbard, Jonathan S Friedstat, Sonia M Thomas, Renee E Edkins, C Scott Hultman, Michael R Kosorok
BACKGROUND/AIMS: Laser treatment of burns scars is considered by some providers to be standard of care. However, there is little evidence-based research as to the true benefit. A number of factors hinder evaluation of the benefit of laser treatment. These include significant heterogeneity in patient response and possible delayed effects from the laser treatment. Moreover, laser treatments are often provided sequentially using different types of equipment and settings, so there are effectively a large number of overall treatment options that need to be compared...
June 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29552919/beyond-total-treatment-effects-in-randomised-controlled-trials-baseline-measurement-of-intermediate-outcomes-needed-to-reduce-confounding-in-mediation-investigations
#20
Sabine Landau, Richard Emsley, Graham Dunn
BACKGROUND: Random allocation avoids confounding bias when estimating the average treatment effect. For continuous outcomes measured at post-treatment as well as prior to randomisation (baseline), analyses based on (A) post-treatment outcome alone, (B) change scores over the treatment phase or (C) conditioning on baseline values (analysis of covariance) provide unbiased estimators of the average treatment effect. The decision to include baseline values of the clinical outcome in the analysis is based on precision arguments, with analysis of covariance known to be most precise...
June 2018: Clinical Trials: Journal of the Society for Clinical Trials
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