Picking and Choosing Among Phase I Trials
This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others ’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collec tive experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials.
Authors: Karimi G, Vard B, Riyahi R, Motlagh ME, Heshmat R, Kelishadi R Abstract This cross-sectional study was conducted among 14,400 Iranian students, aged 7-18 years to determine the association between the frequency of family dinner and mental health. Family dinner frequency, family relationship, life satisfaction (LS), self-perceived health and anxiety were assessed by validated questionnaires. Of 14,274 participants, 50.6% were boys and 71.4% were urban residents, with a mean (SD) age of 12.28 (3.16) years. Family dinner frequency was significantly correlated with LS (boys: β = 0.27, p
In this study we explored the use of a natural compound rubusoside (RUB) as a solubilizer to enhance the solubility of a fluorescence-labeled C6-Ceramide (NBD C6-Ceramide) and to characterize its pharmacokinetics and tissue distribution in an animal model. RUB significantly enhanced the solubility of NBD C6-Ceramide by forming nanomicelles, and efficiently delivered NBD C6-Ceramide in rats by oral and intravenous administration. RUB loaded 1.96% of NBD C6-Ceramide in the nanomicelles and solubilized it to a concentration of 3.6 mg/mL in water. NBD C6-Ceramide in nanomicelles remained stable in aqueous solutions, all...
Publication date: Available online 10 December 2019Source: Prostaglandins &Other Lipid MediatorsAuthor(s): Giorgio Mottola, Evan Werlin, Bian Wu, Mian Chen, Anuran Chatterjee, Melinda Schaller, Michael S. ConteAbstractInflammation ensuing from vascular injury promotes intimal hyperplasia (IH) and restenosis. Resolvin D1 (RvD1) is a lipid mediator that attenuates IH in vivo when delivered locally to the vessel wall in animal models. We tested the hypothesis that peri-procedural oral administration of RvD1 could blunt the local inflammatory response to angioplasty, and attenuate downstream IH. Carotid angioplasty was per...
First-of-its-kind trial evaluates decision aid’s efficacy
Authors: Glauser W PMID: 31818934 [PubMed - in process]
Authors: Owens B PMID: 31818933 [PubMed - in process]
Authors: Dermer M, Martel J, Greenhill A PMID: 31818932 [PubMed - in process]
Authors: Robson R PMID: 31818931 [PubMed - in process]
Authors: Lamb S PMID: 31818930 [PubMed - in process]
Authors: Zimmer V, Glanemann M, Lammert F PMID: 31818929 [PubMed - in process]