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Contemporary Clinical Trials Communications

E Tenti, G Simonetti, M T Bochicchio, G Martinelli
The new Regulation (EU) No. 536/2014 for clinical trials of medicinal products for human is part of a European regulatory framework in which the European Commission has wished to give a strong impetus to scientific research and industrial progress. It is a new regulation that fills a series of regulatory gaps in the Clinical Trials through the creation of a uniform framework for the authorization of clinical trials by all interested Member States with a single assessment of the results. The Regulation thus facilitates cross-border cooperation to make the clinical tests wider and encourage the development of special treatments, for example for rare diseases, but above all streamlines the rules on clinical trials across European Union (EU), introducing simplified rules for experimentation so-called 'low level of intervention', on which much has been discussed and still arouses concern, providing for authorized medicines or used off-label in the presence of scientific evidence published on efficacy and safety and to benefit from they will be mainly the pediatric and oncological therapeutic areas...
September 2018: Contemporary Clinical Trials Communications
Pearl A McElfish, Rachel S Purvis, Christopher R Long
Background: Health research participants want to receive the results from research studies in which they have participated, and health research funding agencies encourage the returning of results to research participants. However, researchers rarely return results to research participants. This study protocol aims to fill the significant gap in knowledge that exists regarding experiences, perceptions, and challenges health researchers have with returning results to research participants...
September 2018: Contemporary Clinical Trials Communications
Fleur O'Hare, Simone Spark, Zachary Flanagan, Stephane Heritier, Andrea Curtis, Sophia Zoungas
Aims: To compare recruitment, refusal and randomisation rates of older adults into a general practice-based clinical trial with two versions (varied format, content and language) of the Participant Information and Consent Form (PICF). Methods: This prospective PICF study was conducted within the STAREE (STAtins in Reducing Events in the Elderly) clinical trial. Participants phone screened between October 2015 to February 2016 formed Group 1 and were mailed the extended PICF version and participants phone screened between October 2016 to February 2017 formed Group 2 and were mailed the shortened PICF version...
September 2018: Contemporary Clinical Trials Communications
Jiacheng Yuan, Daniel Radecki, Denise Bugarin, Till Geib, Jihao Zhou, Jeen Liu
This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a smaller sample size and a shorter overall duration leading to a budget saving of 30% in study operations.
September 2018: Contemporary Clinical Trials Communications
Charikleia Stefanaki, Flora Bacopoulou, Athanasios Michos
Background: Recent studies have demonstrated that a significant proportion of adolescents exhibit abdominal obesity in early-middle adolescence, and impaired glucose metabolism. Dysregulation of glucose metabolism is aggravated by the existing osteosarcopenia not only in obese but also in overweight youth. Biochemical inflammation, derived from glucose metabolism dysregulation, in combination with increased stress levels lead to the accumulation of reactive oxygen species, also known as ROS, which seem to afflict the integrity of the gastrointestinal wall, gut mucosa, and commensal, intestinal gut microflora...
September 2018: Contemporary Clinical Trials Communications
Sarah Browne, Tarweh Carter, Risa Eckes, Greg Grandits, Melvin Johnson, Irene Moore, Laura McNay
Introduction: This article describes a retrospective review of participant follow-up and retention strategies in the Partnership for Research on the Ebola Virus in Liberia (PREVAIL) I Vaccine Trial. It illustrates and analyzes strategies used to retain participants in an emergency clinical research response vaccine trial conducted during the 2014 Ebola outbreak in Liberia. Methods: An anecdotal review of participant retention strategies developed and employed during the PREVAIL I vaccine trial...
September 2018: Contemporary Clinical Trials Communications
Martina Giacalone, Tali Capua, Itai Shavit
Distal forearm fracture is the most common fracture in childhood. Patients with this type of injury suffer from meaningful pain after Emergency Department (ED) discharge. Previous studies demonstrated that short arm (below-the-elbow) casts perform as well as long arm (above-the-elbow) casts for maintaining the reduction of distal forearm fractures, with a similar rate of complications. Consequently, short casts are the commonly used method of immobilization after closed reduction of a distal forearm fractures in children older than 4 years...
September 2018: Contemporary Clinical Trials Communications
Joseph Toninato, Hannah Casey, Mohit Uppal, Tessneem Abdallah, Thomas Bergman, JamesT Eckner, Uzma Samadani
Reporting of sports-related concussions (SRCs) has risen dramatically over the last decade, increasing awareness of the need for treatment and prevention of SRCs. To date most prevention studies have focused on equipment and rule changes to sports in order to reduce the risk of injury. However, increased neck strength has been shown to be a predictor of concussion rate. In the TRAIN study, student-athletes will follow a simple neck strengthening program over the course of three years in order to better understand the relationship between neck strength and SRCs...
September 2018: Contemporary Clinical Trials Communications
Damanpreet K Kandola, Davina Banner, Yuriko Araki, Joanna Bates, Haidar Hadi, Scott A Lear
Background: Telehealth has been proposed as an alternative means to providing traditional modes of care while alleviating the need for participant travel and reducing overall healthcare costs. The purpose of this study was to explore contemporary perspectives of patients and stakeholders regarding non-participation in telehealth trials. Methods: We undertook a two-phase exploratory qualitative study to understand the reasons behind patient non-participation in telehealth...
September 2018: Contemporary Clinical Trials Communications
Twisk J, Bosman L, Hoekstra T, Rijnhart J, Welten M, Heymans M
Background: Regarding the analysis of RCT data there is a debate going on whether an adjustment for the baseline value of the outcome variable should be made. When an adjustment is made, there is a lot of misunderstanding regarding the way this should be done. Therefore, the aims of this educational paper are: 1) to explain different methods used to estimate treatment effects in RCTs, 2) to illustrate the different methods with a real life example and 3) to give an advise on how to analyse RCT data...
June 2018: Contemporary Clinical Trials Communications
Tu Xu, Qin Qin, Xin Wang
The group sequential design has been well understood and widely applied in designs of late phase clinical trial to enable potentially early stopping for efficacy or futility. The information fraction (IF) is one of the key elements to determine the decision boundary at the interim analyses. The family-wise error rate (FWER) control is highly critical for clinical trials with multiple endpoints to be tested. In this article, we illustrate the importance of properly defining the information fraction for each individual endpoint regarding the FWER control through the numerical evaluation and a case study...
June 2018: Contemporary Clinical Trials Communications
Revathi Ananthakrishnan, Stephanie Green, Daniel Li, Michael LaValley
With the emergence of immunotherapy and other novel therapies, the traditional assumption that the efficacy of the study drug increases monotonically with dose levels is not always true. Therefore, dose-finding methods evaluating only toxicity data may not be adequate. In this paper, we have first compared the Modified Toxicity Probability Interval (mTPI) and Toxicity Equivalence Range (TEQR) dose-finding oncology designs for safety with identical stopping rules; we have then extended both designs to include efficacy in addition to safety - we determine the optimal dose for safety and efficacy using these designs by applying isotonic regression to the observed toxicity and efficacy rates, once the early phase trial is completed...
June 2018: Contemporary Clinical Trials Communications
Gregg A Robbins-Welty, Lisa Mueser, Chandler Mitchell, Nicole Pope, Robert Arnold, SeoYoung Park, Doug White, Kenneth J Smith, Charles Reynolds, Margaret Rosenzweig, Marie Bakitas, Yael Schenker
Context: Intervention fidelity is a critical component of behavioral research that has received inadequate attention in palliative care studies. With increasing focus on the need for palliative care models that can be widely disseminated and delivered by non-specialists, rigorous yet pragmatic strategies for training interventionists and maintaining intervention fidelity are needed. Objectives: (1) Describe components of a plan for interventionist training and monitoring and maintaining intervention fidelity as part of a primary palliative care trial (CONNECT) and (2) present data about perceived training effectiveness and delivery of key intervention content...
June 2018: Contemporary Clinical Trials Communications
Sudipta Bhattacharya
Recurrent adverse events, once occur often continue for some duration of time in clinical trials; and the number of events along with their durations is clinically considered as a measure of severity of a disease under study. While there are methods available for analyzing recurrent events or durations or for analyzing both side by side, no effort has been made so far to combine them and present as a single measure. However, this single-valued combined measure may help clinicians assess the wholesome effect of recurrence of incident comprising events and durations...
June 2018: Contemporary Clinical Trials Communications
Christianne L Roumie, Niral J Patel, Daniel Muñoz, Justin Bachmann, Ashton Stahl, Ryan Case, Cardella Leak, Russell Rothman, Sunil Kripalani
Background: The Patient Centered Outcomes Research Institute (PCORI) established Clinical Data Research Networks (CDRNs) to support pragmatic research. The objective was to electronically identify, recruit, and survey coronary heart disease (CHD) patients and describe their characteristics, health status, and willingness to participate in future research. Methods: We developed a computable phenotype and assembled CHD patients 30 years or older and had visits or hospitalizations between 2009 and 2015...
June 2018: Contemporary Clinical Trials Communications
Dalia S Mikhail, Teresa B Jensen, Todd W Wade, Jane F Myers, Jennifer M Frank, Mark Wieland, Don Hensrud, M Molly McMahon, Maria L Collazo-Clavell, Haitham Abu-Lebdeh, Kurt A Kennel, Daniel L Hurley, Karen Grothe, Michael D Jensen
Despite the large number of U.S. adults who overweight or obese, few providers have ready access to comprehensive lifestyle interventions, the cornerstone of medical obesity management. Our goal was to establish a research infrastructure embedded in a comprehensive lifestyle intervention treatment for obesity. The Obesity Treatment Research Program (OTRP) is a multi-specialty project at Mayo Clinic in Rochester, Minnesota designed to provide a high intensity, year-long, comprehensive lifestyle obesity treatment...
June 2018: Contemporary Clinical Trials Communications
Meera Muthukrishnan, Siobhan Sutcliffe, Jean M Hunleth, Jean S Wang, Graham A Colditz, Aimee S James
Background: Colorectal cancer (CRC) is the second most common cancer in the US. Despite evidence that screening reduces CRC incidence and mortality, screening rates are sub-optimal with disparities by race/ethnicity, income, and geography. Rural-urban differences in CRC screening are understudied even though approximately one-fifth of the US population lives in rural areas. This focus on urban populations limits the generalizability and dissemination potential of screening interventions...
June 2018: Contemporary Clinical Trials Communications
Thuva Vanniyasingam, Caitlin Daly, Xuejing Jin, Yuan Zhang, Gary Foster, Charles Cunningham, Lehana Thabane
Objectives: This study reviews simulation studies of discrete choice experiments to determine (i) how survey design features affect statistical efficiency, (ii) and to appraise their reporting quality. Outcomes: Statistical efficiency was measured using relative design (D-) efficiency, D-optimality, or D-error. Methods: For this systematic survey, we searched Journal Storage (JSTOR), Since Direct, PubMed, and OVID which included a search within EMBASE...
June 2018: Contemporary Clinical Trials Communications
Jessica S Merlin, Sarah R Young, Mallory O Johnson, Michael Saag, William Demonte, Robert Kerns, Matthew J Bair, Stefan Kertesz, Janet M Turan, Meredith Kilgore, Olivio J Clay, Dorothy Pekmezi, Susan Davies
Chronic pain is an important comorbidity among individuals with HIV. Behavioral interventions are widely regarded as evidence-based, efficacious non-pharmacologic interventions for chronic pain in the general population. An accepted principle in behavioral science is that theory-based, systematically-developed behavioral interventions tailored to the unique needs of a target population are most likely to be efficacious. Our aim was to use Intervention Mapping to systematically develop a Social Cognitive Theory (SCT)-based intervention for chronic pain tailored to individuals with HIV that will improve pain intensity and pain-related functional impairment...
June 2018: Contemporary Clinical Trials Communications
Thomas Carmody, Tracy L Greer, Robrina Walker, Chad D Rethorst, Madhukar H Trivedi
Objective: Exercise is a promising treatment for substance use disorders, yet an intention-to-treat analysis of a large, multi-site study found no reduction in stimulant use for exercise versus health education. Exercise adherence was sub-optimal; therefore, secondary post-hoc complier average causal effects (CACE) analysis was conducted to determine the potential effectiveness of adequately dosed exercise. Method: The STimulant use Reduction Intervention using Dosed Exercise study was a randomized controlled trial comparing a 12 kcal/kg/week (KKW) exercise dose versus a health education control conducted at nine residential substance use treatment settings across the U...
June 2018: Contemporary Clinical Trials Communications
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