Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.
The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.
In the United States, when a test article is unapproved or not yet cleared by the Food and Drug Administration (FDA), or when an approved or cleared test article is used in a way that may significantly increase the risks (or decreases the acceptability of the risks), the data obtained from the pre-clinical studies or other supporting evidence, case studies of off label use, etc. are submitted in support of an Investigational New Drug (IND) application to the FDA for review prior to conducting studies that involve even one human and a test article if the results are intended to be submitted to or held for inspection by the FDA at any time in the future (in the case of an already approved test article, if intended to submit or hold for inspection by the FDA in support of a change in labeling or advertising). Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption (IDE) application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA.
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This course covers the steps in the development and commercialization of drugs, medical devices, food and nutritional products. The aim is to educate and motivate students to explore career paths in t
This course integrates knowledge in basic, systems, clinical and computational neuroscience, and engineering with the goal of translating this integrated knowledge into the development of novel method
Individual research during the semester under the guidance of a professor or an assistant.
The Declaration of Helsinki (DoH, Helsingin julistus, ) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics. It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations.
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought.
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research done at that institution to ensure that the projects are ethical. Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans, and they are legally required in some countries under certain specified circumstances.
Explores the challenges of inferring epidemiological parameters from clinical data, focusing on COVID-19 and the complexities of estimating infection fatality ratios.
Sometimes treatment effects are absent in a subgroup of the population. For example, penicillin has no effect on severe symptoms in individuals infected by resistant Staphylococcus aureus, and codeine has no effect on pain in individuals with certain polym ...
Background aims: Age-related macular degeneration (AMD) is the most common cause of blindness in elderly patients within developed countries, affecting more than 190 million worldwide. In AMD, the retinal pigment epithelial (RPE) cell layer progressively d ...
IMPACT (Isotope and Muon Production with Advanced Cyclotron and Target Technologies) is a proposed initia- tive envisaged for the high-intensity proton accelerator fa- cility (HIPA) at the Paul Scherrer Institute (PSI). As part of IMPACT, a radioisotope ta ...