|
Clinical Trials Publication
Clinical trials publication is having research published in a peer reviewed journal following clinical trials. Most investigators will want to have such a publication but the nature of clinical trials may create special considerations and obstacles. Most agreements for a clinical trial between sponsor and investigator grants that the sponsor may control publication of results by requesting publication delays, deleting portions of a manuscript, or placing limits on the types of issues that can be discussed. These controls serve to prevent disclosure of information that would compromise the sponsor's ability to patent inventions; to prevent disclosure of confidential information shared with investigator; and to coordinate the disclosure of results when a clinical trial is being conducted at multiple sites. These are legitimate business concerns, but may not restrict the investigator from freely publishing research results in the end of the study and approval process. Due to repe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Peer Review
Peer review is the evaluation of work by one or more people with similar competencies as the producers of the work (peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. Peer review methods are used to maintain quality standards, improve performance, and provide credibility. In academia, scholarly peer review is often used to determine an academic paper's suitability for publication. Peer review can be categorized by the type of activity and by the field or profession in which the activity occurs, e.g., medical peer review. It can also be used as a teaching tool to help students improve writing assignments. Henry Oldenburg (1619–1677) was a German-born British philosopher who is seen as the 'father' of modern scientific peer review. Professional Professional peer review focuses on the performance of professionals, with a view to improving quality, upholding standards, or providing certification. In academia, peer ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Sponsor (commercial)
Sponsoring something (or someone) is the act of supporting an event, activity, person, or organization financially or through the provision of products or services. The individual or group that provides the support, similar to a benefactor, is known as the sponsor. Definition Sponsorship is a cash and/or in-kind fee paid to a property (typically in sports, arts, entertainment or causes) in return for access to the exploitable commercial potential associated with that property. While the sponsoree (property being sponsored) may be nonprofit, unlike philanthropy, sponsorship is done with the expectation of a commercial return. While sponsorship can deliver increased awareness, brand building and propensity to purchase, it is different from advertising. Unlike advertising, sponsorship can not communicate specific product attributes. Nor can it stand alone, as sponsorship requires support elements. Theories A range of psychological and communications theories have been used to exp ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Patent
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A patent is not the grant of a right to make or use or sell. It does not, directly or indirectly, imply any such right. It grants only the right to exclude others. The supposition that a right to make is created by the patent grant is obviously inconsistent with the established distinctions between generic and specific patents, and with the well-known fact that a very considerable portion of the patents granted are in a field covered by a former relatively generic or basic patent, are tributary to such earlier patent, and cannot be practiced unless by license thereunder." – ''Herman v. Youngstown Car Mfg. Co.'', 191 F. 579, 584–85, 112 CCA 185 (6th Cir. 1911) In most countries, patent rights fall under private law and the patent holder mus ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Company
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
The Observer
''The Observer'' is a British newspaper published on Sundays. It is a sister paper to ''The Guardian'' and ''The Guardian Weekly'', whose parent company Guardian Media Group Limited acquired it in 1993. First published in 1791, it is the world's oldest Sunday newspaper. History Origins The first issue, published on 4 December 1791 by W.S. Bourne, was the world's first Sunday newspaper. Believing that the paper would be a means of wealth, Bourne instead soon found himself facing debts of nearly £1,600. Though early editions purported editorial independence, Bourne attempted to cut his losses and sell the title to the government. When this failed, Bourne's brother (a wealthy businessman) made an offer to the government, which also refused to buy the paper but agreed to subsidise it in return for influence over its editorial content. As a result, the paper soon took a strong line against radicals such as Thomas Paine, Francis Burdett and Joseph Priestley. 19th century In 180 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Chilling Effect (law)
In a legal context, a chilling effect is the inhibition or discouragement of the legitimate exercise of natural and legal rights by the threat of legal sanction. A chilling effect may be caused by legal actions such as the passing of a law, the decision of a court, or the threat of a lawsuit; any legal action that would cause people to hesitate to exercise a legitimate right (freedom of speech or otherwise) for fear of legal repercussions. When that fear is brought about by the threat of a libel lawsuit, it is called libel chill. A lawsuit initiated specifically for the purpose of creating a chilling effect may be called a Strategic Lawsuit Against Public Participation (SLAPP). "Chilling" in this context normally implies an undesirable slowing. Outside the legal context in common usage; any coercion or threat of coercion (or other unpleasantries) can have a chilling effect on a group of people regarding a specific behavior, and often can be statistically measured or be plainl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Academic Clinical Trials
An academic clinical trial is a clinical trial not funded by pharmaceutical or biotechnology company for commercial ends but by public-good agencies (usually universities or medical trusts) to advance medicine. These trials are a valuable component of the health care system; they benefit patients and help determine the safety and efficacy of drugs and devices, and play an important role in the checks and balances that regular commercially oriented clinical trials. A typical area of academic clinical trials is the advancement and optimization of already existing therapies. Thus, academic clinical trials may for instance test how a combination of registered drugs may improve treatment outcomes; or they may apply registered treatments in additional, less frequent indications. Such research questions are not a primary focus of for-profit companies, and thus these trials are typically initiated by individual investigators or academic research organizations. There are many different ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Contract Research Organization
In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biological assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and Real world evidence. CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets. They aim to simplify entry into drug markets, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant. CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMA, etc.). Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices. However, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Non-disclosure Agreement
A non-disclosure agreement (NDA) is a legal contract or part of a contract between at least two parties that outlines confidential material, knowledge, or information that the parties wish to share with one another for certain purposes, but wish to restrict access to. Doctor–patient confidentiality (physician–patient privilege), attorney–client privilege, priest–penitent privilege and bank–client confidentiality agreements are examples of NDAs, which are often not enshrined in a written contract between the parties. It is a contract through which the parties agree not to disclose any information covered by the agreement. An NDA creates a confidential relationship between the parties, typically to protect any type of confidential and proprietary information or trade secrets. As such, an NDA protects non-public business information. Like all contracts, they cannot be enforced if the contracted activities are illegal. NDAs are commonly signed when two companies, individu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Preregistration (science)
Preregistration is the practice of registering the hypotheses, methods, and/or analyses of a scientific study before it is conducted. This can include analyzing primary data or secondary data. Clinical trial registration is similar, although it may not require the registration of a study's analysis protocol. Finally, registered reports include the peer review and in principle acceptance of a study protocol prior to data collection. Preregistration assists in the identification and/or reduction of a variety of potentially problematic research practices, including p-hacking, publication bias, data dredging, inappropriate forms of post hoc analysis, and (relatedly) HARKing. It has recently gained prominence in the open science community as a potential solution to some of the issues that are thought to underlie the replication crisis. However, critics have argued that it may not be necessary when other open science practices are implemented such as Registered Reports. Types Standar ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
.jpg "Click for more on -> Clinical Trial")
.jpg "Click for more on -> Sponsor (commercial)")
_(6982162417).jpg "Click for more on -> Pharmaceutical Company")
