|
Surrogate Endpoint
In clinical trials, a surrogate endpoint (or surrogate marker) is a Outcome measure, measure of effect of a specific treatment that may correlate with a ''real'' clinical endpoint but does not necessarily have a guaranteed relationship. The National Institutes of Health (USA) defines surrogate endpoint as "a biomarker intended to substitute for a clinical endpoint". Surrogate markers are used when the primary endpoint is undesired (e.g., death), or when the number of events is very small, thus making it impractical to conduct a clinical trial to gather a statistical significance, statistically significant number of endpoints. The Food and Drug Administration, FDA and other regulatory agencies will often accept evidence from clinical trials that show a direct clinical benefit to surrogate markers. Surrogate endpoints can be obtained from different modalities, such as, behavioural or cognitive scores, or biomarkers from Electroencephalography (Quantitative electroencephalography, qEE ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, 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 institutional review board, 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 experiment, pi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Oncology
Oncology is a branch of medicine that deals with the study, treatment, diagnosis, and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's Etymology, etymological origin is the Greek word ὄγκος (''ónkos''), meaning "tumor", "volume" or "mass". Oncology is focused on the diagnosis of cancer in a person, therapy (e.g., surgery, chemotherapy, radiotherapy and other modalities), monitoring of patients after treatment, palliative care of people with advanced-stage cancers, Ethics, ethical questions surrounding cancer care, Screening (medicine), screening of patients, and the study of cancer treatments through clinical research. An oncologist typically focuses on a specialty area in cancer treatment, such as surgery, Radiation therapy, radiation, gynecology, gynecologic oncology, geriatrics, geriatric oncology, pediatrics, pediatric oncology, and various organ-specific disciplines (breast, brain, liver, among others). The exp ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
FDA Accelerated Approval Program
The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. The faster approval relies on use of surrogate endpoints. Drug approval typically requires clinical trials with endpoints that demonstrate a clinical benefit, such as increased survival for cancer patients. Drugs with accelerated approval can initially be tested in clinical trials that use a surrogate endpoint, or something that is thought to predict clinical benefit. Surrogate endpoints typically require less time, and in the case of a cancer patient, it is much faster to measure a reduction in tumor size, for example, than overall patient survival. Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and those trials are known as phase 4 confirmatory trials. If the drug later proves unable ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Randomized Controlled Trials
A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures, diets or other medical treatments. Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled. By randomly allocating participants among compared treatments, an RCT enables ''statistical control'' over these influences. Provided it is designed well, conducted properly, and enrolls enough participants, an RCT may achieve sufficient control over these confounding factors to deliver a useful comparison of the treatments studied. Definition and examples An RCT in clinical research typically compares a proposed new treatment against an existing standard of care; these are then termed the 'experi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Researchers
Research is creative and systematic work undertaken to increase the stock of knowledge. It involves the collection, organization, and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness to controlling sources of bias and error. These activities are characterized by accounting and controlling for biases. A research project may be an expansion of past work in the field. To test the validity of instruments, procedures, or experiments, research may replicate elements of prior projects or the project as a whole. The primary purposes of basic research (as opposed to applied research) are documentation, discovery, interpretation, and the research and development (R&D) of methods and systems for the advancement of human knowledge. Approaches to research depend on epistemologies, which vary considerably both within and between humanities and sciences. There are several forms of research: scientific, humanities, artistic, economic, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Standard Protocol Items Recommendations For Interventional Trials
Standard may refer to: Symbols * Colours, standards and guidons, kinds of military signs * Standard (emblem), a type of a large symbol or emblem used for identification Norms, conventions or requirements * Standard (metrology), an object that bears a defined relationship to a unit of measure used for calibration of measuring devices * Standard (timber unit), an obsolete measure of timber used in trade * Breed standard (also called bench standard), in animal fancy and animal husbandry * BioCompute Standard, a standard for next generation sequencing * ''De facto'' standard, product or system with market dominance * Gold standard, a monetary system based on gold; also used metaphorically for the best of several options, against which the others are measured * Internet Standard, a specification ratified as an open standard by the Internet Engineering Task Force * Learning standards, standards applied to education content * Standard displacement, a naval term describing the weig ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CONSORT
__NOTOC__ Consort may refer to: Music * "The Consort" (Rufus Wainwright song), from the 2000 album ''Poses'' * Consort of instruments, term for instrumental ensembles * Consort song (musical), a characteristic English song form, late 16th–early 17th centuries Places * Consort, Alberta, a village in Alberta, Canada * Consort Islands, two small islands in the Dion Islands, Marguerite Bay, Antarctica * Consort Mountain, in the Victoria Cross Ranges, Alberta, Canada Titles * Royal consort, a spouse, concubine or companion, in particular the spouse of a reigning monarch: **Queen consort, wife of a reigning king ** Prince consort, husband of a reigning princess or queen ** King consort, rarely used alternative title for husband of a reigning queen ** Princess consort, wife of a reigning prince; also, rarely used alternative title for wife of a reigning king **Viceregal consort of Canada, spouse of the Governor General of Canada Other uses * Consolidated Standards of Reporting ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Epidemiologists
Epidemiology is the study and analysis of the distribution (who, when, and where), patterns and determinants of health and disease conditions in a defined population, and application of this knowledge to prevent diseases. It is a cornerstone of public health, and shapes policy decisions and evidence-based practice by identifying risk factors for disease and targets for preventive healthcare. Epidemiologists help with study design, collection, and statistical analysis of data, amend interpretation and dissemination of results (including peer review and occasional systematic review). Epidemiology has helped develop methodology used in clinical research, public health studies, and, to a lesser extent, basic research in the biological sciences. Major areas of epidemiological study include disease causation, transmission, outbreak investigation, disease surveillance, environmental epidemiology, forensic epidemiology, occupational epidemiology, screening, biomonitoring, and comparis ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinicians
A clinician is a health care professional typically employed at a skilled nursing facility or clinic. Clinicians work directly with patients rather than in a laboratory, community health setting or in research. A clinician may diagnose, treat and care for patients as a psychologist, clinical pharmacist, clinical scientist, nurse, occupational therapist, speech-language pathologist, physiotherapist, dentist, optometrist, physician assistant, clinical officer, physician, paramedic, or chaplain. Clinicians undergo and take comprehensive training and exams to be licensed and some complete graduate degrees (master's or doctorates) in their field of expertise. The main function of a clinician is to manage a sick person in order to cure their illness, reduce pain and suffering, and extend life considering the impact of illness upon the patient and their family as well as other social factors. See also * List of healthcare occupations A listing of health care professions by medica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Randomized Controlled Trials
A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures, diets or other medical treatments. Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled. By randomly allocating participants among compared treatments, an RCT enables ''statistical control'' over these influences. Provided it is designed well, conducted properly, and enrolls enough participants, an RCT may achieve sufficient control over these confounding factors to deliver a useful comparison of the treatments studied. Definition and examples An RCT in clinical research typically compares a proposed new treatment against an existing standard of care; these are then termed the 'exper ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Aducanumab
Aducanumab, sold under the brand name Aduhelm, is an anti-amyloid drug designed to treat Alzheimer's disease. It is a monoclonal antibody that targets aggregated forms (plaque) of amyloid beta (Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup. It was developed by Biogen and Eisai. Aducanumab is given via intravenous infusion. Aducanumab was approved for medical use in the United States by the Food and Drug Administration (FDA) in June 2021, in a controversial decision that led to the resignation of three advisers to the FDA in the absence of evidence that the medication is effective. The FDA stated that it represents a first-of-its-kind treatment approved for Alzheimer's disease and that it is the first new treatment approved for Alzheimer's since 2003. Aducanumab's approval is controversial for numerous reasons including ambiguous clinical trial results regarding efficacy, the high cost of the medication and the very high rate of serious adve ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Alzheimer's Disease
Alzheimer's disease (AD) is a neurodegenerative disease and the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As the disease advances, symptoms can include problems with language, disorientation (including easily getting lost), mood swings, loss of motivation, self-neglect, and behavioral issues. As a person's condition declines, they often withdraw from family and society. Gradually, bodily functions are lost, ultimately leading to death. Although the speed of progression can vary, the average life expectancy following diagnosis is three to twelve years. The causes of Alzheimer's disease remain poorly understood. There are many environmental and genetic risk factors associated with its development. The strongest genetic risk factor is from an allele of apolipoprotein E. Other risk factors include a history of head injury, clinical depression, and high blood pressure. The progression of the di ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
