Estimand framework: Delineating what to be estimated with clinical questions of interest in clinical trials
ICH (International Council for Harmonization) E9 R1 (2019) proposes a framework to define estimands in clinical trials. Although the concept of estimand was proposed previously when US Food and Drug Administration (FDA) issued the panel report on handling missing data in clinical trials, many details including attributes and different strategies have not been developed until the recent ICH E9 (R1) addendum. A clearly defined estimand should include considerations of five attributes including patient population, treatment regimen of interest, endpoint/variables, handling of intercurrent events (IEs), and summary measures fo...
Source: Contemporary Clinical Trials - August 6, 2020 Category: Radiology Authors: Man Jin, Guanghan Liu Source Type: research
Rationale, design, and methods of the autism centers of excellence (ACE) network study of oxytocin in autism to improve reciprocal social behaviors (SOARS-B)
To describe the rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 6, 2020 Category: Radiology Authors: Marina Spanos, Tara Chandrasekhar, Soo-Jeong Kim, Robert M. Hamer, Bryan H. King, Christopher J. McDougle, Kevin B. Sanders, Simon G. Gregory, Alexander Kolevzon, Jeremy Veenstra-VanderWeele, Linmarie Sikich Source Type: research
Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients
We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 6, 2020 Category: Radiology Authors: Federico E. Vaca, James Dziura, Fuad Abujarad, Michael V. Pantalon, Allen Hsiao, Craig A. Field, Gail D'Onofrio Source Type: research
The effect of preventing subclinical transmission on the containment of COVID-19: Mathematical modeling and experience in Taiwan
The control strategies preventing subclinical transmission differed among countries. A stochastic transmission model was used to assess the potential effectiveness of control strategies at controlling the COVID-19 outbreak. Three strategies included lack of prevention of subclinical transmission (Strategy A), partial prevention using testing with different accuracy (Strategy B) and complete prevention by isolating all at-risk people (Strategy C, Taiwan policy). The high probability of containing COVID-19 in Strategy C is observed in different scenario, had varied in the number of initial cases (5, 20, and 40), the reproduc...
Source: Contemporary Clinical Trials - August 5, 2020 Category: Radiology Authors: Hsiao-Hui Tsou, Yu-Chieh Cheng, Hsiang-Yu Yuan, Ya-Ting Hsu, Hsiao-Yu Wu, Fang-Jing Lee, Chao A. Hsiung, Wei J. Chen, Huey-Kang Sytwu, Shiow-Ing Wu, Shu-Man Shih, Tzai-Hung Wen, Shu-Chen Kuo Source Type: research
Weight management for adults with mobility related disabilities: Rationale and design for an 18-month randomized trial
Adults with mobility related disabilities (MRDs) represent an underserved group with a high prevalence of overweight/obesity and limited options for weight management. We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs ( −6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity. However, the costs/logistics associated with intervention delivery by individual home visits limits the potential for scaling and i mplementation of this approach. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 4, 2020 Category: Radiology Authors: Richard A. Washburn, Lauren T. Ptomey, Anna M. Gorczyca, Patricia R. Smith, Matthew S. Mayo, Robert Lee, Joseph E. Donnelly Source Type: research
Recent advances in clinical trial design considerations in Thera “nostics”
Theranostics in drug development is an evolving framework, known as combining ‘thera’ (a therapeutic drug) with ‘nostics’ (a diagnostic imaging drug) and with the latter being mostly used to select patient for evaluation of safety and efficacy of an investigational therapeutics. However, when a diagnostic imaging drug is still investigational, patient selection perfor mance of a nostics imaging has not been demonstrated. Clinical trials conducted to assess the effect of an investigational therapeutics in a theranostics setting may focus only on the therapeutics development and not necessarily require definitive tru...
Source: Contemporary Clinical Trials - August 4, 2020 Category: Radiology Authors: Sue-Jane Wang Source Type: research
Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss
Behavioral interventions produce clinically significant weight reduction, with many participants regaining weight subsequently. Most interventions focus on an individual, but dietary and physical activity behaviors occur with, or are influenced by, domestic partners. According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change. We utilized interdependence theory to develop a partner-assisted intervention to increase long-term weight loss. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 31, 2020 Category: Radiology Authors: Corrine I. Voils, Ryan Shaw, Rachel Adler, Elizabeth Jeanes, Megan A. Lewis, Whitney Sharp, Kate A. Cronin, Scott Hetzel, Lu Mao, Heather M. Johnson, Felix Elwert, Samantha Pabich, Kara L. Gavin, William S. Yancy Jr., Laura S. Porter Source Type: research
Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 31, 2020 Category: Radiology Source Type: research
Patient-centered and efficacious advance care planning in cancer: Protocol and key design considerations for the PEACe-compare trial
Failure to deliver care near the end of life that reflects the needs, values and preferences of patients with advanced cancer remains a major shortcoming of our cancer care delivery system. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 29, 2020 Category: Radiology Authors: Judith M. Resick, Robert M. Arnold, Rebecca L. Sudore, David Farrell, Shane Belin, Andrew D. Althouse, Betty Ferrell, Bernard J. Hammes, Edward Chu, Douglas B. White, Kimberly J. Rak, Yael Schenker Source Type: research
Design and rationale of a multicenter defeat alcoholic steatohepatitis trial: (DASH) randomized clinical trial to treat alcohol-associated hepatitis
Despite high mortality of alcohol-associated hepatitis, there has been limited advancement in treatment strategies. Defeat Alcoholic Steatohepatitis (DASH) is a multicenter, randomized, double-blind controlled trial whose primary objective was to evaluate the safety and efficacy of a novel combination of 3 drugs targeting different perturbations in AH. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 29, 2020 Category: Radiology Authors: Srinivasan Dasarathy, Mack C. Mitchell, Bruce Barton, Craig J. McClain, Gyongyi Szabo, Laura E. Nagy, Svetlana Radaeva, Arthur J. McCullough Source Type: research
Cancer history and risk factors in healthy older people enrolling in the ASPREE clinical trial
Cancer is a leading cause of death globally. Given the elevated risk of cancer with age and an ageing population, it is important to understand the changing burden of cancer in older populations. The ASPirin in Reducing Events in the Elderly (ASPREE) study randomised healthy older individuals to 100 mg aspirin or placebo, with clinical outcomes and disability-free survival endpoints. Detailed baseline data provides a rare opportunity to explore cancer burden in a uniquely healthy older population. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 29, 2020 Category: Radiology Authors: Suzanne G. Orchard, Jessica E. Lockery, Peter Gibbs, Galina Polekhina, Rory Wolfe, John Zalcberg, Andrew Haydon, John J. McNeil, Mark R. Nelson, Christopher M. Reid, Brenda Kirpach, Anne M. Murray, Robyn L. Woods, ASPREE Investigator Group Source Type: research
Randomized controlled trial of the COPE-P intervention to improve mental health, healthy lifestyle behaviors, birth and post-natal outcomes of minority pregnant women: Study protocol with implications
Emotionally distressed pregnant minority women experience multiple adverse outcomes, including pre-eclampsia, preterm birth, operative deliveries and low birth weight. Although the United States Preventive Services Task Force recommends screening in pregnant women, many practices do not screen because efficacious interventions and systems are not in place to treat them. Aim: Purpose of this randomized controlled trial (RCT) is to test a group delivered manualized cognitivebehavioral skills building intervention entitled COPE-P versus an attention control program on the mental health, birth and postpartum outcomes of minori...
Source: Contemporary Clinical Trials - July 29, 2020 Category: Radiology Authors: Bernadette Mazurek Melnyk, Susan Gennaro, Laura A. Szalacha, Jacqueline Hoying, Caitlin O'Connor, Andrea Cooper, Anne Gibeau Source Type: research
Adaptive design implementation in confirmatory trials: Methods, practical considerations and case studies
The rapidly changing drug development landscapes have brought unique challenges to sponsors in designing clinical trials in a faster and more efficient way. With the ability to accelerate development timeline, reduce redundant sample size, and select the right dose and patient population during the clinical trial, adaptive designs help to increase the probability of success of clinical trials and eventually contribute to bringing the promising drugs to patients earlier and fulfilling their unmet medical needs. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 29, 2020 Category: Radiology Authors: Qing Li, Jianchang Lin, Yunzhi Lin Source Type: research
Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care
For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people ...
Source: Contemporary Clinical Trials - July 28, 2020 Category: Radiology Authors: Megan A. Lewis, Camilla Harshbarger, Carla Bann, Olivia Burrus, Susana Peinado, Bryan R. Garner, Olga Khavjou, Ram K. Shrestha, Shawn Karns, Craig B. Borkowf, Brittany A. Zulkiewicz, Alexa Ortiz, Carla A. Galindo, Michelle DallaPiazza, Pam Holm, Vincent C Source Type: research
The home air in agriculture pediatric intervention (HAPI) trial: Rationale and methods
Data addressing air quality effects on children with asthma in rural U.S. communities are rare. Our community engaged research partnership previously demonstrated associations between neighborhood NH3 and ambient PM2.5 and asthma in the agricultural lower Yakima Valley of Washington. As a next step, the partnership desired an intervention approach to address concerns about pediatric asthma in this largely Latino immigrant, farm worker community. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 24, 2020 Category: Radiology Authors: Erin E. Masterson, Lisa B. Younglove, Adriana Perez, Elizabeth Torres, Jennifer E. Krenz, Maria I. Tchong French, Anne M. Riederer, Paul D. Sampson, Nervana Metwali, Esther Min, Karen L. Jansen, Gino Aisenberg, Ryan S. Babadi, Stephanie A. Farquhar, Peter Source Type: research
