Sequential monitoring of covariate adaptive randomized clinical trials with sample size re-estimation
Once scientific questions are determined, other design features of clinical trials including increasing the power while controlling the type I error rate, planning interim analysis, and achieving treatment balance among subgroups will be either required or preferred. We propose to sequentially monitor the covariate adaptive randomization (CAR) procedures with sample size re-estimation (SSR) to satisfy a variety of design objectives of clinical trials. However, each of the three adaptive designs (sequential monitoring, CAR, and SSR) poses a challenge to the control of the type I error rate. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 31, 2019 Category: Radiology Authors: Jun Yu, Dejian Lai Source Type: research
Study to Promote Innovation in Rural Integrated Telepsychiatry (SPIRIT): Rationale and design of a randomized comparative effectiveness trial of managing complex psychiatric disorders in rural primary care clinics
Managing complex psychiatric disorders like PTSD and bipolar disorder is challenging in Federally Qualified Health Centers (FQHCs) delivering care to U.S residents living in underserved rural areas. This protocol paper describes SPIRIT, a pragmatic comparative effectiveness trial designed to compare two approaches to managing PTSD and bipolar disorder in FQHCs. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 29, 2019 Category: Radiology Authors: John C. Fortney, Patrick J. Heagerty, Amy M. Bauer, Joseph M. Cerimele, Debra Kaysen, Paul N. Pfeiffer, Melissa J. Zielinski, Jeffrey M. Pyne, Deb Bowen, Joan Russo, Lori Ferro, Danna Moore, J.P. Nolan, Florence C. Fee, Tammy Heral, Jode Freyholtz-London, Source Type: research
The SAFE-trial: Safe surgery for glioblastoma multiforme: Awake craniotomy versus surgery under general anesthesia. Study protocol for a multicenter prospective randomized controlled trial
Surgery of GBM nowadays is usually performed under general anesthesia (GA) and resections are often not as aggressive as possible, due to the chance of seriously damaging the patient with a rather low life expectancy. A surgical technique optimizing resection of the tumor in eloquent areas but preventing neurological deficits is necessary to improve survival and quality of life in these patients. Awake craniotomy (AC) with the use of cortical and subcortical stimulation has been widely implemented for low-grade glioma resections (LGG), but not yet for GBM. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 28, 2019 Category: Radiology Authors: Jasper K.W. Gerritsen, Markus Klimek, Clemens M.F. Dirven, Esther Oomen-de Hoop, Michiel Wagemakers, Geert Jan M. Rutten, Alfred Kloet, Giorgio G. Hallaert, Arnaud J.P.E. Vincent Source Type: research
Biostatistics pitfalls: Lessons learned from analysis of medical data
In several recent issues of The Lancet, we identified a few common pitfalls in the analysis of clinical trial and medical data in the published articles (Mok et al., 2019; Herrlinger et al., 2019; Reindl-Schwaighofer et al., 2019; He et al., 2019). Without careful validation of model assumptions, even the primary endpoint of the trial might be analyzed using improper statistical methods. We carried out an in-depth analysis of the statistical issues in four real clinical trials, which highlights the importance of statistics in the medical field. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 28, 2019 Category: Radiology Authors: Guosheng Yin, Chenyang Zhang, Zhao Yang Tags: Short Communication Source Type: research
Awake craniotomy versus craniotomy under general anaesthesia for glioblastoma multiforme (the SAFE-trial): Study protocol for a randomized controlled trial
Glioblastoma Multiforme (GBM) or astrocytoma's grade IV (WHO) are devastating tumors with one of the worst prognoses in oncology. Extending resection improves survival in patients with GBM. Surgery of GBM nowadays is usually performed under general anaesthesia (GA) and resections are not as aggressive as possible, due to the chance of seriously damaging the patient with a rather low life expectancy. A surgical technique optimizing resection of the tumor in eloquent areas but preventing neurological deficits is necessary to improve survival and quality of life in these patients. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 28, 2019 Category: Radiology Authors: Jasper K.W. Gerritsen, Markus Klimek, Clemens M.F. Dirven, Esther Oomen, Michiel Wagemakers, Geert Jan M. Rutten, Alfred Kloet, Giorgio G. Hallaert, Arnaud J.P.E. Vincent Source Type: research
Design of a comparative outcome analysis of open, laparoscopic, or robotic-assisted incisional or inguinal hernia repair utilizing surgeon experience and a novel follow-up model
In a recent publication, the International Guidelines for Groin Hernia Management by the European Hernia Society (EHS) recognized the need to individualize and tailor the surgical approach for hernia repair. There may be different opportunities for optimization of the surgical technique for surgeons performing open, laparoscopic, or robotic-assisted hernia repair. Robotic-assisted hernia repair is a relatively new minimally invasive surgical approach compared to laparoscopic and open repair. Currently, there is a lack of comparative prospective studies designed to evaluate long-term outcomes of patients undergoing robotic-...
Source: Contemporary Clinical Trials - October 24, 2019 Category: Radiology Authors: Karl A. LeBlanc Source Type: research
Serum 25-hydroxyvitamin D in the VITamin D and OmegA-3 TriaL (VITAL): Clinical and demographic characteristics associated with baseline and change with randomized vitamin D treatment
The VITamin D and OmegA-3 TriaL (VITAL) is a completed randomized, placebo-controlled trial of vitamin D3 (2000 IU/day) and marine omega-3 (1 g/day) supplements in the primary prevention of cancer and cardiovascular disease. Here we examine baseline and change in 25-hydroxyvitamin D (25(OH)D) and related biomarkers with randomized treatment and by clinical factors. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 23, 2019 Category: Radiology Authors: Heike Luttmann-Gibson, Samia Mora, Carlos A. Camargo, Nancy R. Cook, Olga V. Demler, Amit Ghoshal, Jay Wohlgemuth, Kris Kulkarni, Julia Larsen, James Prentice, Michael Cobble, Vadim Bubes, Chunying Li, Georgina Friedenberg, I-Min Lee, Julie E. Buring, JoA Source Type: research
Preventing child mental health problems through parenting interventions in Southeastern Europe (RISE): Protocol for a multi-country cluster randomized factorial study
Child mental health problems continue to be a major global concern, especially in low- and middle-income countries (LMICs). Parenting interventions have been shown to be effective for reducing child behavior problems in high-income countries, with emerging evidence supporting similar effects in LMICs. However, there remain substantial barriers to scaling up evidence-based interventions due to limited human and financial resources in such countries. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 23, 2019 Category: Radiology Authors: Jamie M. Lachman, Nina Heinrichs, Elena Jansen, Antonia Br ühl, Diana Taut, Xiangming Fang, Frances Gardner, Judy Hutchings, Catherine L. Ward, Margiad Elen Williams, Marija Raleva, Adriana Båban, Galina Lesco, Heather M. Foran Source Type: research
Hybrid clinical trials to generate real-world evidence: design considerations from a sponsor's perspective
Randomized controlled trials have traditionally been the gold standard for evaluating efficacy and safety of medical products and for regulatory decision-making. With the advancement of information technologies, vast amounts of data pertinent to patient health status and health care delivery are becoming available from a variety of real-world sources, including electronic health records, medical claims, patient registries, and patient-generated data. In 2016, the United States Congress passed the 21st Century Cures Act, mandating the U.S. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 23, 2019 Category: Radiology Authors: Ming Zhu, Saranya Sridhar, Rosalind Hollingsworth, Ayman Chit, Tammy Kimball, Kerry Murmello, Michael Greenberg, Sanjay Gurunathan, Josh Chen Source Type: research
Enhanced exposure therapy for combat-related Posttraumatic Stress Disorder (PTSD): Study protocol for a randomized controlled trial
PTSD, which has been identified in up to 23% of post-9-11 veterans, often results in a chronic, pernicious course. Thus, effective treatments are imperative. The Institute of Medicine (IOM) concluded that the only intervention for PTSD with sufficient evidence to conclude efficacy is exposure therapy. This Phase III trial compares the efficacy of exposure therapy for combat-related PTSD delivered in two different formats- via virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS), a cognitive enhancer shown to facilitate the extinction of fear. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 23, 2019 Category: Radiology Authors: JoAnn Difede, Barbara O. Rothbaum, Albert A. Rizzo, Katarzyna Wyka, Lisa Spielman, Tanja Jovanovic, Christopher Reist, Michael J. Roy, Seth D. Norrholm, Charles Glatt, Francis Lee Source Type: research
Bayesian hypothesis testing with frequentist characteristics in clinical trials
Through the use of an informative prior, Bayesian methodologies could potentially borrow the strength of historical information and become more and more popular for their applications to clinical trials. Nonetheless, even with tremendous effort, the reconciliation of the formulation of the hypotheses and the calculation of type I error between a Bayesian analysis and traditional frequentist analysis is still not very clear. In this research, we apply an inferential prior, null prior and design prior to the Bayesian data analysis, type I error control and sample size calculation. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 23, 2019 Category: Radiology Authors: Hui Quan, Bingzhi Zhang, Yu Lan, Xiaodong Luo, Xun Chen Source Type: research
Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study
The objectives of this study are: 1) to determine whether either of two patient-centered treatment models – patient navigation (PN) or modified directly observed therapy (mDOT) – results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence ( (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 23, 2019 Category: Radiology Authors: Alain H. Litwin, John Jost, Katherine Wagner, Moonseong Heo, Alison Karasz, Judith Feinberg, Arthur Y. Kim, Paula J. Lum, Shruti H. Mehta, Lynn E. Taylor, Judith I. Tsui, Irene Pericot-Valverde, Kimberly Page, the HERO Study Group Source Type: research
A relationship-based approach to improving clinical trials: The imCORE research network experience
The rapid evolution of cancer immunotherapies has increased demand for timely introduction of new therapies and subsequently increased the demand on leading cancer research institutions worldwide. As a leader in cancer therapy research, Roche created the immunotherapy Centers of Research Excellence (imCORE) Network, a worldwide research network designed to more closely connect members in an open environment of shared information, expertise, and decisions. This network is dedicated to increasing the understanding of the underlying science in order to prioritize and accelerate the most promising new treatment options for pat...
Source: Contemporary Clinical Trials - October 23, 2019 Category: Radiology Authors: Sarah Helou, Camber Gadberry, San Tran, Nickolas Zahara, Jon Talbot, Tanya Vidhyarkorn, Claire Nickols, Janice Russell, Dan Otap, Sarah Churchill, Myriam Estrabaut, Jessica Piggee, Catherine Scher Source Type: research
Telephone interventions for co-morbid insomnia and osteoarthritis pain: The OsteoArthritis and therapy for sleep (OATS) randomized trial design
The OsteoArthritis and Therapy for Sleep (OATS) study is a population-based randomized controlled trial of cognitive behavioral therapy for insomnia (CBTI) with four innovative methodological aims. These are to: (1) Enroll representative participants across Washington state, including those from medically underserved communities; (2) Enroll persons with persistent insomnia and chronic osteoarthritis (OA) pain; (3) Test a scalable CBT-I intervention; and (4) Evaluate patient-reported outcomes (insomnia, pain severity, fatigue, depression) and cost-effectiveness over one year. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 12, 2019 Category: Radiology Authors: Susan M. McCurry, Michael Von Korff, Charles M. Morin, Amy Cunningham, Kenneth C. Pike, Manu Thakral, Robert Wellman, Kai Yeung, Weiwei Zhu, Michael V. Vitiello Source Type: research
A pragmatic, adaptive clinical trial design for a rare disease: The FOcal Cerebral Arteriopathy Steroid (FOCAS) trial
We present a pragmatic approach to clinical trial design that may inform the approach to other rare disorders. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 12, 2019 Category: Radiology Authors: Yeonhee Park, Heather J. Fullerton, Jordan J. Elm Source Type: research
