Clinical trial in the context of "Preclinical research"

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⭐ Core Definition: Clinical trial

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. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.

Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.

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👉 Clinical trial in the context of Preclinical research

In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.

The main goals of preclinical studies are to determine a starting, safe dose for first-in-human study and assess potential toxicity of the product, which typically include new medical devices, prescription drugs, and diagnostics.

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Clinical trial in the context of Neurology

Neurology (from Greek: νεῦρον (neûron), "string, nerve" and the suffix -logia, "study of") is the branch of medicine dealing with the diagnosis and treatment of all categories of conditions and disease involving the nervous system, which comprises the brain, the spinal cord and the peripheral nerves. Neurological practice relies heavily on the field of neuroscience, the scientific study of the nervous system, using various techniques of neurotherapy.

A neurologist is a physician specializing in neurology and trained to investigate, diagnose and treat neurological disorders. Neurologists diagnose and treat myriad neurologic conditions, including stroke, epilepsy, movement disorders such as Parkinson's disease, brain infections, autoimmune neurologic disorders such as multiple sclerosis, sleep disorders, brain injury, headache disorders like migraine, tumors of the brain and dementias such as Alzheimer's disease. Neurologists may also have roles in clinical research, clinical trials, and basic or translational research. Neurology is a nonsurgical specialty, its corresponding surgical specialty is neurosurgery.

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Clinical trial in the context of Medical research

Medical research (or biomedical research), also known as health research, refers to the process of using scientific methods with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of health.

Medical research encompasses a wide array of research, extending from "basic research" (also called bench science or bench research), – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine.

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Clinical trial in the context of Baseline (science)

A baseline in science (including medicine) is the initial conditions found by observation and measurement at the beginning of a survey or clinical trial or which is used for comparison with later data collected during or after the survey or trial to identify and measure changes, often with the intention of assessing the effects of a treatment or procedure.

In environmental science a baseline study is necessary to be able to accurately determine impact by monitoring the environment and comparing the changing situation with the initial conditions after development has occurred. In some cases, baseline information already be available from previous surveys, but it may be necessary to gather data in the field.

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Clinical trial in the context of COVID-19 drug development

COVID-19 drug development is the research process to develop preventative therapeutic prescription drugs that would alleviate the severity of coronavirus disease 2019 (COVID-19). From early 2020 through 2021, several hundred drug companies, biotechnology firms, university research groups, and health organizations were developing therapeutic candidates for COVID-19 disease in various stages of preclinical or clinical research (506 total candidates in April 2021), with 419 potential COVID-19 drugs in clinical trials, as of April 2021.

As early as March 2020, the World Health Organization (WHO), European Medicines Agency (EMA), US Food and Drug Administration (FDA), and the Chinese government and drug manufacturers were coordinating with academic and industry researchers to speed development of vaccines, antiviral drugs, and post-infection therapies. The International Clinical Trials Registry Platform of the WHO recorded 536 clinical studies to develop post-infection therapies for COVID-19 infections, with numerous established antiviral compounds for treating other infections under clinical research to be repurposed.

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Clinical trial in the context of Alternative medicine

Alternative medicine refers to practices that aim to achieve the healing effects of conventional medicine, but that typically lack biological plausibility, testability, repeatability, or supporting evidence of effectiveness. Such practices are generally not part of evidence-based medicine. Unlike modern medicine, which employs the scientific method to test plausible therapies by way of responsible and ethical clinical trials, producing repeatable evidence of either effect or of no effect, alternative therapies reside outside of mainstream medicine and do not originate from using the scientific method, but instead rely on testimonials, anecdotes, religion, tradition, superstition, belief in supernatural "energies", pseudoscience, errors in reasoning, propaganda, fraud, or other unscientific sources. Frequently used terms for relevant practices are New Age medicine, pseudo-medicine, unorthodox medicine, holistic medicine, fringe medicine, and unconventional medicine, with little distinction from quackery.

Some alternative practices are based on theories that contradict the established science of how the human body works; others appeal to the supernatural or superstitions to explain their effect or lack thereof. In others, the practice has plausibility but lacks a positive risk–benefit outcome probability. Research into alternative therapies often fails to follow proper research protocols (such as placebo-controlled trials, blind experiments and calculation of prior probability), providing invalid results. History has shown that if a method is proven to work, it eventually ceases to be alternative and becomes mainstream medicine.

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Clinical trial in the context of Beneficence (ethics)

Beneficence in general means "active well-doing". Duties of beneficence form a part of various religious and secular ethical theories. As an applied ethical concept relating to research, beneficence means that researchers should have the welfare of the research participant as a goal of any clinical trial or other research study. The antonym of this term, maleficence, describes a practice that opposes the welfare of any research participant. According to the Belmont Report, researchers are required to follow two moral requirements in line with the principle of beneficence: do not harm, and maximize possible benefits for research while minimizing any potential harm on others.

The idea that medical professionals and researchers would always practice beneficence seems natural to most patients and research participants, but in fact, every health intervention or research intervention has potential to harm the recipient. There are many different precedents in medicine and research for conducting a cost–benefit analysis and judging whether a certain action would be a sufficient practice of beneficence, and the extent to which treatments are acceptable or unacceptable is under debate.

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