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Drug evaluation in children
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
It is accepted that sick children need to be treated by paediatric health professionals. Similarly for clinical trials involving children, paediatric health care professionals need to be involved, ideally within a paediatric unit. One, therefore, cannot perform a paediatric clinical trial in an adult clinical trials unit. Clinical trials and other aspects of paediatric drug research can be performed in district general hospitals [1]. For general paediatric conditions, these units are probably preferable to tertiary centres where one is more likely to see a highly selective patient group that is not representative of children throughout the community.
Ethics Analysis of Radiotherapy Scenarios
Published in Jim Malone, Friedo Zölzer, Gaston Meskens, Christina Skourou, Ethics for Radiation Protection in Medicine, 2018
Jim Malone, Friedo Zölzer, Gaston Meskens, Christina Skourou
Dr Loeen recently joined Spring Clinic as a staff radiation oncologist. She requests that all her patients be scanned daily while on treatment. Even though she cannot show evidence of benefit to the patient, she argues ‘If weekly imaging is good for the patient, daily imaging can only be better’. Dr Loeen’s request is made with her best intentions for the well being of her patients. However, it will cause a fivefold increase in the number of scans. The additional risk with no proven benefit scores an (N) for both non-maleficence and prudence. Mr Brickfielder, the medical physicist in the department who has calculated the increase in dose to the patient from daily scanning, understands that it is his professional responsibility to question Dr Loeen’s instructions. He insists that any change in practice unsupported by evidence should be initiated under the auspices of the clinical trials unit with ethics approval. To initiate such a study is time consuming and Dr Loeen tells Mr Brickfielder to ‘Stay out of it’ and that ‘Her patients are not going to receive suboptimal treatment because of bureaucracy’. The choice to ignore expert advice and follow established pathways to ensure the safety of the patient scores a capital (N) for honesty. As her proposed practice is justified by her experience and may be proven beneficial to the patient if properly studied, and as she will consent the patient for the additional exposure, her practice scores a small (y) for beneficence and for autonomy (Table 5.1).
Mutual Benefit, Added Value?
Published in Ann H. Kelly, P. Wenzel Geissler, The Value of Transnational Medical Research, 2013
This brief record of my first contact with the world of clinical trials stays with me as an example of the mindfulness with which my fellow researchers approach their work and its definition. At the time, the clinic is one of approximately 10 centres gathering data for a major multinational study, funded by one of the biggest pharmaceutical companies in the world. Though the site looks like a hospital ward to me – curtained bays, a single desk staffed by nurses, weighing machine – the investigators clearly distinguish the place from therapeutic settings. Commercial funding helps make this spatial strategy possible by funding a kind of clinical trials unit formally affiliated to a university rather than the hospital. This institutional separation is reflected in arrangements for recruitment to the trial and the use of medication within it.
Tolerability, safety, pharmacokinetics and pharmacodynamics of SHR0534, a potent G protein-coupled receptor 40 (GPR40) agonist, at single- and multiple-ascending oral doses in healthy Chinese subjects
Published in Xenobiotica, 2021
Yuqing Zhao, Lijun Xie, Ning Ou, Jie Wu, Hongwen Zhang, Sufeng Zhou, Yun Liu, Juan Chen, Lu Wang, Libin Wang, Jingjing Wang, Feng Shao
This was a phase-I, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study (ClinicalTrials.gov Identifier: NCT02750553) in healthy Chinese subjects to determine the safety/tolerability and PK/PD characteristics of SHR0534 oral tablets. A pilot trial, single-blinded to timely assess safety at the first dose of 5 mg, and a main trial, double-blinded to evaluate safety/tolerability and PK/PD characteristics, were parts of this study. The overview of the trial flow and design are shown in Figure 1 and Table 1. The study was conducted at the Phase I Clinical Trial Unit in Jiangsu Province Hospital (Nanjing, China). All eligible subjects were randomly assigned into a single-dose treatment period, followed by a washout period of 9 days, and then a 14-day multiple-dose treatment period was continued at the same dose levels.
Valvular Resistance and Bleeding Events Among Patients Undergoing Transcatheter Aortic Valve Replacement
Published in Structural Heart, 2019
Masahiko Asami, Thomas Pilgrim, Stefan Stortecky, Fabien Praz, Jonas Lanz, Dik Heg, Eva Roost, Stephan Windecker, Lukas Hunziker
All patients undergoing TAVR for AS at Bern University Hospital are consecutively included into a prospective registry as part of the Swiss TAVI Registry (ClinicalTrials.gov NCT01368250). For the purpose of the present analysis, we considered consecutive patients that underwent TAVR between August 2007 and December 2015 and had available RHC data for calculating VR before the intervention. Device selection and all decisions regarding peri-procedural management were carefully based on preprocedural heart team assessment and imaging data. The study has been approved by the local ethics committee and all participants provided written informed consent for participation in the registry. Data was prospectively entered in a web-based database held at the Clinical Trial Unit at the University of Bern, Switzerland.
Effects of a tailored multidisciplinary counselling intervention to support the adjustment process after a traumatic injury: a randomized controlled trial
Published in Disability and Rehabilitation, 2022
Julia Katharina Hegy, Sandra Abegglen, Volker Schade, Ulrike Hoffmann-Richter, Hansjörg Znoj
The study was designed as a randomized controlled trial consisting of an intervention group and a control group. The study population consisted of German speaking, adult workers (≥18 years) who suffered an accident within 3 months prior to the participation in this study. Ethical approval was obtained from the Ethics Committee of the University of Bern (No. 2011-04-172) and the study was registered at the ISRCTN registry (ISRCTN05534684). Furthermore, the study was monitored and assessed by the Clinical Trial Unit Bern, an independent national clinical trial management facility coordinating patient-oriented clinical research.