Meta-analysis of blinded and unblinded studies for ongoing aggregate safety monitoring and evaluation
During the course of clinical development, ongoing aggregate safety monitoring and evaluation are needed to understand the evolving safety profile and to ensure effective risk-management strategies for medicinal products. CIOMS reports and global regulatory guidance (including from ICH, US FDA, and EMA) compel sponsors for assessment of safety based on aggregate data. To identify and characterize the risks of medicinal products at a program level in a more timely and informed manner, aggregate safety evaluations should combine all available information, including from ongoing blinded trials, completed unblinded trials, and...
Source: Contemporary Clinical Trials - June 26, 2020 Category: Radiology Authors: Li-An Lin, Shuai Sammy Yuan, Nathan Li, Greg Ball Source Type: research
Caring for older veterans with chronic low back pain using a geriatric syndrome approach: Rationale and methods for the aging back clinics (ABC) trial
The purpose of the ongoing trial is to improve care of older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6 months on ≥ half the days). Current CLBP care is limited by being either overly spine-focused or non-specifically prescribed and both approaches frequently lead to suboptimal reduction in pain and improvement in function. Through prior studies we have laid the foundation for a patient-cente red approach to care for older Veterans with CLBP in which the spine is a source of vulnerability but not the sole treatment target. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 24, 2020 Category: Radiology Authors: Debra K. Weiner, Angela Gentili, Meika A. Fang, Edward Garay, Thiru Annaswamy, Steven Castle, Lenore Joseph, Laura Lawson, Cathy C. Lee, Una E. Makris, Michelle I. Rossi, Beverly Thorn, Kimberly Clemens, Dave Newman, Subashan Perera Source Type: research
Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City)
We describe the design of a pragmatic trial to evaluate the incremental effectiveness of metformin, as an adjunct to a simple lifestyle counseling. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 20, 2020 Category: Radiology Authors: Luis A. Rodr íguez, Simón Barquera, Carlos A. Aguilar-Salinas, Jaime Sepúlveda-Amor, Luz María Sánchez-Romero, Edgar Denova-Gutiérrez, Nydia Balderas, Lizbeth Moreno-Loaeza, Margaret A. Handley, Sanjay Basu, Oliva López-Arellano, Alberto Gallardo-H Source Type: research
Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design
Calcium intake is critical for adequate bone mineralization in adolescence, but it is usually inadequate in US adolescents. A strategy to maximize bone mineralization is to increase calcium absorption, which could be achieved by soluble corn fiber (SCF). There are no studies determining the long-term effects of SCF on bone mass in children. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 19, 2020 Category: Radiology Authors: C. Palacios, Trak-Fellermeier, C.M. P érez, F. Huffman, Y. Hernandez Suarez, Z. Bursac, T.B. Gambon, C.H. Nakatsu, C.M. Weaver Source Type: research
A prospective, multi-center randomized, controlled, blinded trial of vagus nerve stimulation for difficult to treat depression: A novel design for a novel treatment
Few treatment options exist for patients with difficult-to-treat depression (DTD). One potentially efficacious treatment is vagus nerve stimulation (VNS): chronic stimulation of the vagus nerve using an implanted stimulator. Given a series of recent VNS clinical studies, including a large, five-year naturalistic investigation, the Center for Medicare and Medicaid Services (CMS) reconsidered the previous non coverage determination and announced coverage for patients participating in a “coverage with evidence” trial. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 18, 2020 Category: Radiology Authors: Charles R. Conway, Bryan Olin, Scott T. Aaronson, Harold A. Sackeim, Mark Bunker, Christopher Kriedt, Theresa Greco, Kristine Broglio, Matteo Vestrucci, A. John Rush Source Type: research
Emergency department safety assessment and follow-up evaluation 2: An implementation trial to improve suicide prevention
Emergency departments (EDs) are important for preventing suicide. Historically, many patients with suicide risk are not detected during routine clinical care, and those who are often do not receive suicide-specific intervention. The original Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE 1) study examined the implementation of universal suicide risk screening and a multi-component ED-initiated suicide prevention intervention. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 17, 2020 Category: Radiology Authors: Edwin D. Boudreaux, Brianna L. Haskins, Celine Larkin, Lori Pelletier, Sharon A. Johnson, Barbara Stanley, Gregory Brown, Kristin Mattocks, Yunsheng Ma Source Type: research
A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol
Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 15, 2020 Category: Radiology Authors: C.R. Pearson, D. Kaysen, D. Huh, M. Bedard-Gillgan, D. Walker, R. Marin, K. Saluskin Source Type: research
A randomized clinical trial of a collaborative home-based diabetes intervention to reduce emergency department visits and hospitalizations in black individuals with diabetes
The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system. These three factors account for higher rates of acute medical care use in blacks with DM. To address this disparity, we developed DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care), a home-based multidisciplinary behavioral intervention that integrates care from a community health worker (CHW), the participant's primary care physician (...
Source: Contemporary Clinical Trials - June 15, 2020 Category: Radiology Authors: Robin Casten, Barry Rovner, Anna Marie Chang, Judd E. Hollander, Megan Kelley, Benjamin Leiby, Ginah Nightingale, Laura Pizzi, Neva White, Kristin Rising Source Type: research
Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial
Posttraumatic stress disorder (PTSD) is the most highly prevalent mental health disorder among U.S. military Veterans. Prolonged Exposure (PE) therapy is one of the most widely used evidence-based treatments for PTSD, but there is substantial room for improvement in outcomes and retention rates. Accumulating data suggest that oxytocin offers a promising pharmacological approach towards achieving this goal. Therefore, the primary objective of this two-site Phase II study is to examine the ability of oxytocin (vs. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 15, 2020 Category: Radiology Authors: Julianne C. Flanagan, Jennifer M. Mitchell, Nathaniel L. Baker, Joshua Woolley, Bethany Wangelin, Sudie E. Back, John R. McQuaid, Thomas C. Neylan, William R. Woolfe, Kathleen T. Brady Source Type: research
Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 11, 2020 Category: Radiology Source Type: research
Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review
Informed consent is an essential requirement prior to clinical trial participation, however some ‘vulnerable’ groups, such as people with cognitive impairments and those in medical emergency situations, may lack decisional capacity to consent. This raises ethical and practical challenges when designing and conducting clinical trials involving these populations, who are frequently excluded a s a result. Despite recent advances in improving informed consent processes, there has been far less attention paid to the enrolment of adults lacking capacity. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 7, 2020 Category: Radiology Authors: Victoria Shepherd Source Type: research
Extensions of the 2-in-1 adaptive design
The 2-in-1 adaptive design [Chen et al. 2018] allows seamless expansion of an ongoing Phase 2 trial into a Phase 3 trial to expedite a drug development program. An intermediate endpoint can be used for the adaptive decision. Under a mild assumption that is expected to generally hold in practice, both the Phase 2 trial (in case of no expansion) and the Phase 3 trial (in case of expansion) can be tested at the full alpha level without inflating the overall Type I error of the study. Due to its flexibility and robustness, the design has quickly generated a lot of interest since its recent publication. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 2, 2020 Category: Radiology Authors: Cong Chen, Wen Li, Qiqi Deng Source Type: research
Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART)
There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 30, 2020 Category: Radiology Authors: Michele Heisler, Jeffrey Kullgren, Caroline Richardson, Shelley Stoll, Cristina Alvarado Nieves, Deanne Wiley, Tali Sedgwick, Alyce Adams, Monique Hedderson, Eileen Kim, Megan Rao, Julie A. Schmittdiel Source Type: research
Design, data linkage, and implementation considerations in the first cooperative group led study assessing financial outcomes in cancer patients and their informal caregivers
We report our experience navigating design and implementation barriers. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 29, 2020 Category: Radiology Authors: Veena Shankaran, Joseph M. Unger, Amy K. Darke, Dawn L. Hershman, Scott D. Ramsey Source Type: research
A pharmacy liaison-patient navigation intervention to reduce inpatient and emergency department utilization among primary care patients in a Medicaid accountable care organization: A pragmatic trial protocol.
To determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital....
Source: Contemporary Clinical Trials - May 29, 2020 Category: Radiology Authors: Karen E. Lasser, Pablo Buitron de la Vega, Erin M. Ashe, Ziming Xuan, Sonia Alva, Leandra Battisti, Stephanie Losi, Christina Sieber, Carla Richards, Patricia Sullivan, Leah Triscari, Lauren Brody, Mary-Tara Roth, Alison LeBlanc, Michael Silverstein Source Type: research
