Clinical Trials
Michael Ljungberg in Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
In the European Clinical Trial Regulation (EU No 536/2014), the wider term “clinical study” is used to identify any research performed on human subjects with the intention to gain an understanding of the effect of a drug/intervention from a clinical, pharmacological, and/or pharmacodynamic perspective. The overall aim of any clinical study is to ascertain the safety and/or efficacy of a medicinal product. According to the same document, a clinical trial is a prospective clinical study where the treatment under study is one that is not considered normal clinical practice and the decision to include a subject in the study is directly related to the decision to offer them the investigational treatment. Furthermore, the safety and efficacy of the treatment is evaluated using procedures that are more elaborate than what would be considered standard clinical practice. The term “clinical trial” thus more specifically describes a prospectively conducted medical interventional experiment, while “clinical study” may include, for example, retrospective and observational approaches as well.
Epidemiology: The Methods and their Utilization
Lars Granath, William D. McHugh in Systematized Prevention of Oral Disease: Theory and Practice, 2019
The terms efficacy, effectiveness, and efficiency are widely used and have been defined in several ways by different authors. In this chapter, we will use the words effectiveness and efficiency and omit efficacy from our vocabulary, although the latter word is most often used as a synonym for effectiveness. We will begin by stating that the usefulness of a preventive measure, that is to say its effectiveness and efficiency, are established after successful replications of clinical trials of the agent. These clinical trials are of two types: controlled clinical trials and community clinical trials. The controlled clinical trial measures the effectiveness of a preventive measure and the community clinical trial measures its efficiency. In some cases, but not usually, a clinical trial can have elements of both the controlled and community varieties.
Clinical trials: acute and chronic pain
Harald Breivik, William I Campbell, Michael K Nicholas in Clinical Pain Management, 2008
Is the clinical trial necessary, and is it ethical to randomize patients and to give placebo treatment? The answer to these questions depends on what we know about the treatments in question. In medical practice, potentially harmful treatments are often given without any documentation of effect. The major ethical question is to evaluate the balance between the importance of the objective of the study and the inherent risk to the participating subject. The degree of risk and discomfort must be favorably balanced by the probability of benefit to the patient or to patients in general. Participation in a clinical trial may have several advantages for the patient. However, even a modest additional discomfort or risk would be unethical if the study were designed in a way to preclude useful conclusions, or if the results for some reason are withheld from publication. Thus, proper study design, including placebo when relevant and publication of the results, are important ethical imperatives.16
The complexities of AAC intervention research: emerging trends to consider
Published in Augmentative and Alternative Communication, 2018
MaryAnn Romski, Rose A. Sevcik
The World Health Organization (WHO) has developed an International Clinical Trials Registry Platform (ICTRP; http://www.who.int/ictrp/en/). The WHO website states that, ‘The registration of all interventional trials is a scientific, ethical and moral responsibility’. A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials also may be referred to as intervention trials. Interventions include, but are not restricted to, drugs, cells, and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials, as described in Table 1.
A systematic review of evaluating the efficacy of acne scar treatment by Fractional Laser with or without using adjunctive treatments
Published in Journal of Cosmetic and Laser Therapy, 2021
A systematic literature review was performed by searching the electronic databases PubMed, Google Scholar and Embase. Search terms included “Fractional laser,” “acne scar,” “Skin treatment” and, “Randomized control trail.” The search results on PubMed, Google Scholar, and Embase were screened for duplicates, which resulted in a total of 1387 unique records that were screened based on title and abstract. 1268 articles were excluded and the remaining 119 reports were screened based on full text. Randomized controlled trials, controlled clinical trials, clinical trials, comparative study, prospective clinical trial, cohort study, retrospective study were included. Pilot study, in vitro and review were excluded. The reviewed articles were analyzed and compared on study design, treatment protocol, laser parameters, and therapeutic results. 40 articles met our inclusion criteria.
Effect of patient-reported outcomes as a dialogue-based tool in cancer consultations on patient self-management and health-related quality of life: a clinical, controlled trial
Published in Acta Oncologica, 2021
Pernille Christiansen Skovlund, Henriette Vind Thaysen, Henrik Schmidt, Jan Alsner, Niels Henrik Hjollund, Kirsten Lomborg, Berit Kjærside Nielsen
In this prospective non-randomized controlled, clinical trial, patients were assigned to either the intervention (systematic feedback of completed PRO-measures to physicians during each consultation) or the control group (treatment as usual without any use of PRO-measures in the consultation). No extra time was allocated for consultations in any of the two groups. The intervention took place at the Department of Oncology, Aarhus University Hospital, Denmark. Patients in the control group were recruited from two other departments in Denmark treating patients with metastatic melanoma (Odense University Hospital and Herlev Hospital). All patients were recruited from June 2017 to July 2019. Outcomes were measured at baseline, and after 3, 6, and 12 months using the following questionnaires: Patient Activation Measure (PAM), Functional Assessment of Cancer Therapy – Melanoma (FACT-M), Cancer Behavior Inventory – Brief Version (CBI-B), Perceived Efficacy in Patient–Physician Interaction (PEPPI).
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