China
Africa
Explore chapters and articles related to this topic
Patient autonomy and criminal law
Published in Paweł Daniluk, Patient Autonomy and Criminal Law, 2023
According to Sec. 11, Part 1 of the Law on the Rights of Patients, involvement of a patient in a clinical study approved in accordance with the procedures prescribed by regulatory acts on clinical studies is subject to the patient's written informed consent. Legal protection of a person who participates in the research process is similar to that of a patient. Detailed procedure for participation by a person in a research process, upon informed consent obtain from the person or the person's representative, is stipulated in the Cabinet Regulations No. 280 ‘Regulations Concerning the Procedure for Conduct of Clinical Study and Assessment of the Findings; Procedure for Labelling of the Medication under Research and Procedure for Assessment of Conformity of the Clinical Study of the Medication with the Requirements of Good Clinical Practice' of 23 March 2010.9
Off-label use of medicines between clinical research and practice
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
In contrast, if healthcare professionals choose to pursue research on a given off-label use, they may initiate a post-authorisation study. This is because off-label uses concern medicines that have already been authorised. Therefore, studies on such uses, by definition, qualify as post-authorisation studies. Post-authorisation studies may be clinical trials or non-interventional studies. Clinical trials require a protocol designed according to the Good Clinical Practice (GCP) principles (Art. 1(2), Directive 2001/20), the free and informed consent of the research participant,67 and a favourable opinion of the competent ethics committee according to the Directive and national implementing legislation (Art. 9(1), Directive 2001/20).68
Designing and Running a Clinical Trial
Published in Trevor F. Cox, Medical Statistics for Cancer Studies, 2022
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (https://www.ich.org) has guidelines for Good Clinical Practice (GCP). There are 13 core principles for GCP, which we will not repeat here, they include ethics, risks, safety and well-being for subjects, information to be made available, etc.
Clinical trials for neuroregenerative therapies for spinal cord injury: what have we learnt so far?
Published in Expert Review of Neurotherapeutics, 2023
Raymond Wong, Nader Hejrati, Michael G. Fehlings
Lastly, Good Clinical Practice (GCP) regulations represent an international standard for the design, conduct, and reporting of SCI clinical trials. Accordingly, proper documentation of every aspect of clinical trials, including study protocols, case report forms, informed consent forms, and other trial-related documents is required to ensure that studies are conducted in a standardized manner so that results are accurate and reliable [84]. Importantly, study documentation must be kept secure and confidential, but also readily retrievable for review and inspection by regulatory agencies and other authorized parties (e.g. sponsor, contract research organization). External audits are necessary to ensure compliance and involves a qualified third party doing an independent review of the clinical trial to verify that it is being conducted in accordance with study protocol, GCP regulations, and other applicable laws [84]. Investigators of SCI clinical trials should be familiar with GCP regulations to ensure proper study documentation and conduct.
Hepatic safety of the antifungal triazole agent posaconazole: characterization of adverse event reports in a manufacturer’s safety database
Published in Expert Opinion on Drug Safety, 2022
Rose O’Flynn, Yun-Ping Zhou, Hetty Waskin, Ronald Leong, Walter Straus
The global safety database of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD), contains all spontaneous AE cases (including those in the literature) and noninterventional study AE cases reported to the company in the postmarketing period as well as all serious AEs (SAEs) reported in company-sponsored interventional clinical trials and investigator-initiated studies. MSD clinical trials are run in accordance with the Declaration of Helsinki, Good Clinical Practice requirements, and applicable country and/or local statutes and regulations regarding Institutional Ethics Committee review, written informed consent, and protection of human participants in biomedical research. The level of clinical information varies considerably across reported cases and is dependent on the quality and completeness of submitted data [23]. After receiving and analyzing each report, the manufacturer codes the case using preferred terms (PTs) from the Medical Dictionary for Regulatory Activities (MedDRA) current at the time the reports were entered [24]. To protect patient privacy and avoid duplicate reports, each report (or case) is assigned a unique identification number.
PASTEC - a prospective, single-center, randomized, cross-over trial of pure physical versus physical plus attentional training in children with cancer
Published in Pediatric Hematology and Oncology, 2022
Andrea Fontana, Sonia Matthey, Claire Mayor, Céline Dufour, Alice Destaillats, Pierluigi Ballabeni, Stéphane Maeder, Christopher J. Newman, Maja Beck Popovic, Raffaele Renella, Manuel Diezi
Patients treated at our institution were contacted sequentially and offered the possibility to participate in the PA program until 24 slots were filled. Inclusion criteria were diagnosis of cancer, age 6-18 years and a foreseeable weekly participation in the program. Exclusion criteria were physical limitations, therapy side effects that would preclude active participation, auto-/allogeneic stem cell transplantation or planned surgical procedures. Patients with a fully implantable venous access could be included in the study. Patients were not excluded on predetermined complete blood count cutoffs. Patients were followed by a pediatric oncologist during the study to discontinue participation if deemed necessary. The trial was approved by the local Institutional Review Board (IRB) (CER-VD-n°182/15) and conducted in accordance with the Declaration of Helsinki. Informed consent was obtained according to institutional guidelines and good clinical practices.