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STEPS Trial
The STEPS trial (an acronym for Study of Neurontin: Titrate to Efficacy, Profile of Safety) was a clinical trial sponsored by Parke-Davis (now Pfizer) to evaluate the anticonvulsant Neurontin. It is notable for being a seeding trial to promote that drug and for contributing to the drug companies loss in the court case '' Franklin v. Parke-Davis''. Detailed documents were released due to litigation against Parke-Davis and reviewed by several researchers in a 2011 ''Annals of Internal Medicine'' article. The STEPS trial was presented as a phase IV clinical trial with the stated objective to "study efficacy, safety, tolerability, and quality of life among gabapentin users"; however, the trial was actually completely uncontrolled and unblinded and the scientific validity of the trial was considered dubious by independent external sources. Documents also revealed that the trial recruited 772 physician investigators, many with very limited research experience, provided inadequate tr ... [...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] |
Parke-Davis
Parke-Davis is a subsidiary of the pharmaceutical company Pfizer. Although Parke, Davis & Co. is no longer an independent corporation, it was once America's oldest and largest drug maker, and played an important role in medical history. In 1970 Parke-Davis was acquired by Warner–Lambert, which in turn was acquired by Pfizer in 2000. History Parke, Davis and Company was founded in Detroit, Michigan by Dr. Samuel P. Duffield, a physician and pharmacist. In 1860, Dr. Duffield owned a small drugstore at the corner of Gratiot and Woodward Avenues. Dr. Duffield made a variety of pharmaceutical preparations, including Hoffman’s anodyne and mercurial ointment, but was overwhelmed by the operations of the business. Dr. Duffield and Hervey Coke Parke formed a partnership in October 1866, with George S. Davis becoming a third partner in 1867. Parke was a businessman looking for business opportunities and Davis, an ambitious man with skills in sales. Duffield withdrew in 1869 beca ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pfizer
Pfizer Inc. ( ) is an American Multinational corporation, multinational Pharmaceutical industry, pharmaceutical and biotechnology corporation headquartered at The Spiral (New York City), The Spiral in Manhattan, New York City. Founded in 1849 in New York by German entrepreneurs Charles Pfizer (1824–1906) and Charles F. Erhart (1821–1891), Pfizer is one of the oldest pharmaceutical companies in North America. Pfizer develops and produces medicines and vaccines for immunology, oncology, cardiology, endocrinology, and neurology. The company's largest products by sales are the Pfizer–BioNTech COVID-19 vaccine ($11 billion in 2023 revenues), apixaban ($6 billion in 2023 revenues), a pneumococcal conjugate vaccine ($6 billion in 2023 revenues), palbociclib ($4 billion in 2023 revenues), and tafamidis ($3 billion in 2023 revenues). In 2023, 46% of the company's revenues came from the United States, 6% came from Japan, and 48% came from other countries. Pfizer has been a publi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Anticonvulsant
Anticonvulsants (also known as antiepileptic drugs, antiseizure drugs, or anti-seizure medications (ASM)) are a diverse group of pharmacological agents used in the treatment of epileptic seizures. Anticonvulsants are also used in the treatment of bipolar disorder and borderline personality disorder, since many seem to act as mood stabilizers, and for the treatment of neuropathic pain. Anticonvulsants suppress the uncontrolled and excessive firing of neurons during seizures and in doing so can also prevent the spread of the seizure within the brain. Conventional antiepileptic drugs have diverse mechanisms of action but many block sodium channels or enhance γ-aminobutyric acid ( GABA) function. Several antiepileptic drugs have multiple or uncertain mechanisms of action. Next to voltage-gated sodium channels and components of the GABA system, their targets include GABAA receptors, the GABA transporter type 1, and GABA transaminase. Additional targets include voltage-gate ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Neurontin
Gabapentin, sold under the brand name Neurontin among others, is an anticonvulsant medication primarily used to treat neuropathic pain and also for partial seizures of epilepsy. It is a commonly used medication for the treatment of neuropathic pain caused by diabetic neuropathy, postherpetic neuralgia, and central pain. It is moderately effective: about 30–40% of those given gabapentin for diabetic neuropathy or postherpetic neuralgia have a meaningful benefit. Gabapentin, like other gabapentinoid drugs, acts by decreasing activity of the α2δ-1 protein, coded by the CACNA2D1 gene, first known as an auxiliary subunit of voltage gated calcium channels. However, see Pharmacodynamics, below. By binding to α2δ-1, gabapentin reduces the release of excitatory neurotransmitters (primarily glutamate) and as a result, reduces excess excitation of neuronal networks in the spinal cord and brain. Sleepiness and dizziness are the most common side effects. Serious side effects incl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Seeding Trial
A seeding trial or marketing trial is a form of marketing, conducted in the name of research, designed to target product sampling towards selected consumers. In the marketing research field, seeding is the process of allocating marketing to specific customers, or groups of customers, in order to stimulate the internal dynamics of the market, and enhance the diffusion process. In medicine, seeding trials are clinical trials or research studies in which the primary objective is to introduce the concept of a particular medical intervention—such as a pharmaceutical drug or medical device—to physicians, rather than to test a scientific hypothesis. To create loyalty and advocacy towards a brand, seeding trials take advantage of opinion leadership to enhance sales, capitalizing on the Hawthorne Effect. In a seeding trial, the brand provides potential opinion leaders with the product for free, aiming to gain valuable pre-market feedback and also to build support among the testers, creati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Franklin V
Franklin may refer to: People and characters * Franklin (given name), including list of people and characters with the name * Franklin (surname), including list of people and characters with the name * Franklin (class), a member of a historical English social class Places * Franklin (crater), a lunar impact crater * Franklin County (other), in a number of countries * Mount Franklin (other), including Franklin Mountain Australia * Franklin, Tasmania, a township * Division of Franklin, federal electoral division in Tasmania * Division of Franklin (state), state electoral division in Tasmania * Franklin, Australian Capital Territory, a suburb in the Canberra district of Gungahlin * Franklin River, river of Tasmania * Franklin Sound, waterway of Tasmania Canada * District of Franklin, a former district of the Northwest Territories * Franklin, Quebec, a municipality in the Montérégie region * Rural Municipality of Franklin, Manitoba * Franklin, Mani ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Litigation
A lawsuit is a proceeding by one or more parties (the plaintiff or claimant) against one or more parties (the defendant) in a civil court of law. The archaic term "suit in law" is found in only a small number of laws still in effect today. The term "lawsuit" is used with respect to a civil action brought by a plaintiff (a party who claims to have incurred loss as a result of a defendant's actions) who requests a legal remedy or equitable remedy from a court. The defendant is required to respond to the plaintiff's complaint or else risk default judgment. If the plaintiff is successful, judgment is entered in favor of the plaintiff, and the court may impose the legal or equitable remedies available against the defendant (respondent). A variety of court orders may be issued in connection with or as part of the judgment to enforce a right, award damages or restitution, or impose a temporary or permanent injunction to prevent an act or compel an act. A declaratory judgment m ... [...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] |
Tolerability
In pharmacology, tolerability refers to the degree to which overt adverse effects of a drug can be tolerated by a patient. Tolerability of a particular drug can be discussed in a general sense, or it can be a quantifiable measurement as part of a clinical study. Usually, it is measured by the rate of "dropouts", or patients that forfeit participation in a study due to extreme adverse effects. Tolerability, however, is often relative to the severity of the medical condition a drug is designed to treat. For instance, cancer patients may tolerate significant pain or discomfort during a chemotherapeutic study with the hope of prolonging survival or finding a cure, whereas patients experiencing a benign condition, such as a headache, are less likely to. As an example, tricyclic antidepressants (TCAs) are very poorly tolerated and often produce severe side effects including sedation, orthostatic hypotension, and anticholinergic effects, whereas newer antidepressants have far fewer ad ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Of Life
Quality of life (QOL) is defined by the World Health Organization as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns". Standard indicators of the quality of life include wealth, employment, the environment, physical and mental health, education, recreation and leisure time, social belonging, religious beliefs, safety, security and freedom. QOL has a wide range of contexts, including the fields of international development, healthcare, politics and employment. Health related QOL (HRQOL) is an evaluation of QOL and its relationship with health. Engaged theory One approach, called the engaged theory, outlined in the journal of ''Applied Research in the Quality of Life'', posits four domains in assessing quality of life: ecology, economics, politics and culture. In the domain of culture, for example, it includes the following subd ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Scientific Control
A scientific control is an experiment or observation designed to minimize the effects of variables other than the independent variable (i.e. confounding variables). This increases the reliability of the results, often through a comparison between control measurements and the other measurements. Scientific controls are a part of the scientific method. Controlled experiments Controls eliminate alternate explanations of experimental results, especially experimental errors and experimenter bias. Many controls are specific to the type of experiment being performed, as in the molecular markers used in SDS-PAGE experiments, and may simply have the purpose of ensuring that the equipment is working properly. The selection and use of proper controls to ensure that experimental results are valid (for example, absence of confounding variables) can be very difficult. Control measurements may also be used for other purposes: for example, a measurement of a microphone's background noise in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
