Ticagrelor versus placebo for the reduction of vaso-occlusive crises in pediatric sickle cell disease: Rationale and design of a randomized, double-blind, parallel-group, multicenter phase 3 study (HESTIA3)
An unmet need for therapies exists to reduce sickle cell disease (SCD) complications in pediatric patients. Activated platelets contribute to the formation of cellular aggregates during sickling and vaso-occlusive crises (VOCs). Ticagrelor is an oral, direct-acting, and reversible adenosine diphosphate P2Y12 receptor antagonist that inhibits platelet activation and aggregation. Although ticagrelor was well tolerated in two phase 2 studies in children and young adults with SCD, larger and longer-term treatment studies are needed to assess ticagrelor's efficacy to reduce VOCs. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 21, 2019 Category: Radiology Authors: Matthew M. Heeney, Miguel R. Abboud, Carl Amilon, Marielle Andersson, Jessie Githanga, Baba Inusa, Julie Kanter, Maria Leonsson-Zachrisson, Alan D. Michelson, Anders R. Berggren, on behalf of the HESTIA3 study investigators Source Type: research
Assessing readability and comprehension of informed consent materials for medical device research: A survey of informed consents from FDA's Center for Devices and Radiological Health
Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDAs Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs.The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 20, 2019 Category: Radiology Authors: Fabienne Santel, Isatu Bah, Katherine Kim, Ja-An Lin, Jack McCracken, Adaeze Teme Source Type: research
Sequential tests of promise with discrete time-to-event data
We introduce a family of sequential test procedures in the context of a futility study design, or as we prefer to call it, a formal test of promise, suitable for use with time-to-event data. The procedures are motivated by an actual trial that was undertaken to test the promise of very early antiretroviral therapy to achieve viral remission in infants with perinatally-acquired HIV. Important gains in efficiency are illustrated in terms of early stopping and statistical power compared with other methods such as Simon's two-stage design with binary outcomes. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 20, 2019 Category: Radiology Authors: Bruce Levin, Louise Kuhn, Cheng-Shiun Leu, Wei-Yann Tsai Source Type: research
A survey of informed consents from FDA's center for devices and radiological health
Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDA's Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs.The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 20, 2019 Category: Radiology Authors: Fabienne Santel, Isatu Bah, Katherine Kim, Ja-An Lin, Jack McCracken, Adaeze Teme Source Type: research
Defining optimal care for functional gut disorders - Multi-disciplinary versus standard care: A randomized controlled trial protocol
Functional gastrointestinal disorders (FGIDs) are the commonest reason for gastroenterological consultation, with patients usually seen by a specialist working in isolation. There is a wealth of evidence testifying to the benefit provided by dieticians, behavioral therapists, hypnotherapists and psychotherapists in treating these conditions, yet they rarely form a part of the therapeutic team, and these treatment modalities are rarely offered as part of the therapeutic management. There has been little examination of different models of care for FGIDs. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 18, 2019 Category: Radiology Authors: Chamara Basnayake, Michael A. Kamm, Michael Salzberg, Angela Khera, Danny Liew, Kathryn Burrell, Amy Wilson-O'Brien, Annalise Stanley, Nicholas J. Talley, Alexander J. Thompson Source Type: research
