The Korea Research Institute of Standards and Science (KRISS) has developed the world's first reference material to improve the accuracy of body fat measurements conducted through MRI and CT scans. The study is published ...
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Drug development is typically slow: the pipeline from basic research discoveries that provide the basis for a new drug to clinical trials to production of a widely available medicine can take decades. But decades can feel ...
Jun 27, 2024
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Researchers from the University of Missouri School of Medicine found that a targeted gene therapy may make acute myeloid leukemia (AML) more sensitive to chemotherapy, while also protecting the heart against toxicity often ...
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Despite significant improvements in data sharing for cancer clinical trials over the last 10 years, further changes are still needed to ensure patient-centered care, medical advancements, and trust in the pharmaceutical industry, ...
Jun 27, 2024
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Sickle cell disease, a genetic blood disorder, affects about 100,000 Americans. Millions more carry the gene, which can get passed down through generations, and may not know it.
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Eligibility requirements for clinical trials help protect patients whose comorbidities may put them at an additional risk of severe harm from the treatment being tested. Further, they help ensure that analyses are performed ...
Jun 27, 2024
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Underrepresented populations have been historically excluded from clinical trials including women, racial and ethnic minority groups, and pregnant, lactating, pediatric and geriatric populations. While the importance of including ...
Jun 26, 2024
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Service dogs can alleviate some symptoms of post-traumatic stress disorder for veterans, according to a study our team published in June 2024 in the medical journal JAMA Network Open.
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In clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.
Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.
Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be the pharmaceutical or biotechnology company that developed the agent under study. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization
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