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ClinicalTrials.gov
ClinicalTrials.gov is a clinical trials registry, registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and holds registrations from over 444,000 trials from 221 countries. History As a result of pressure from HIV-infected men in the gay community, who demanded better access to clinical trials, the U.S. Congress passed the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) which mandated the development of a database of AIDS Clinical Trials Information Services (ACTIS). This effort served as an example of what might be done to improve public access to clinical trials, and motivated other disease-related interest groups to push for something similar for all diseases. The Food and Drug Administration Modernization Act of 1997 (Public Act 105-115) amended the Food, Drug and Cosmetic Act and the Public Health Service Act to require that the NIH create and operate a public information ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trials Registry
Preregistration is the practice of registering the hypotheses, methods, or analyses of a scientific study before it is conducted. 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 has the goal to transparently evaluate the severity of hypothesis tests,, and can have a number of secondary goals (which can also be achieved without preregistering ), including (a) facilitating and documenting research plans, (b) identifying and reducing questionable research practices and researcher biases, (c) distinguishing between confirmatory and exploratory analyses, and, in the case of Registered Reports, (d) facilitating results-blind peer review, and (e) reducing publication bias. A number of research practices such as p-hacking, publication bias, data dredging, inappropriate forms of po ... [...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] |
International Clinical Trials Registry Platform
The International Clinical Trials Registry Platform (ICTRP) is a platform for the registration of clinical trials operated by the World Health Organization. The ICTRP combines data from multiple cooperating clinical trials registries to generate a global view of clinical trials worldwide, with a search portal that allows access to the entire dataset. It requires a minimum standard set of database fields, the WHO Trial Registration Data Set, to be present for a trial to be registered. All entries are given a Universal Trial Number (UTN) that identifies them uniquely. The organization has sought to assist various national governments in establishing their own clinical trials databases. It combines data from the following primary registries and data providers: * Australian New Zealand Clinical Trials Registry (ANZCTR) * Brazilian Clinical Trials Registry (ReBec) * Chinese Clinical Trial Registry (ChiCTR) * Clinical Research Information Service (CRiS), Republic of Korea * Cli ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration Modernization Act Of 1997
The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising. In 2022, the Act was updated with the FDA Modernization Act 2.0, which cancelled a 1938 mandate to require animal testing for every drug development protocol. History Congressman Richard Burr and Senator James M. Jeffords were the chairperson sponsors of the Food and Drug Administration Regulatory Modernization Act of 1997 or FDA Modernization Act of 1997. The U.S. legislation was signed by Bill Clinton William Jefferson Clinton (né Blythe III; born August 19, 1946) is an American politician and lawyer who was the 42nd president of the United States from 1993 to 2001. A member of the Democratic Party (United States), ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Events
In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects, an adverse event does not necessarily mean the medication directly caused the problem. These events can include any unfavorable symptoms, signs, or medical conditions that appear during medical treatment, regardless of whether they are definitively linked to the specific medication being studied. AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to the local ethics committee. Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are merely documented in t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Library Of Medicine
The United States National Library of Medicine (NLM), operated by the United States federal government, is the world's largest medical library. Located in Bethesda, Maryland, the NLM is an institute within the National Institutes of Health. Its collections include more than seven million books, journals, technical reports, manuscripts, microfilms, photographs, and images on medicine and related sciences, including some of the world's oldest and rarest works. the acting director of the NLM was Stephen Sherry. History The precursor of the National Library of Medicine, established in 1836, was the Library of the Surgeon General's Office, a part of the office of the Surgeon General of the United States Army. The Armed Forces Institute of Pathology and its Medical Museum were founded in 1862 as the Army Medical Museum. Throughout their history the Library of the Surgeon General's Office and the Army Medical Museum often shared quarters. From 1866 to 1887, they were ho ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
PubMed
PubMed is an openly accessible, free database which includes primarily the MEDLINE database of references and abstracts on life sciences and biomedical topics. The United States National Library of Medicine (NLM) at the National Institutes of Health maintains the database as part of the Entrez system of information retrieval. From 1971 to 1997, online access to the MEDLINE database was provided via computer and phone lines primarily through institutional facilities, such as university libraries. PubMed, first released in January 1996, ushered in the era of private, free, home- and office-based MEDLINE searching. The PubMed system was offered free to the public starting in June 1997. Content In addition to MEDLINE, PubMed provides access to: * older references from the print version of '' Index Medicus'', back to 1951 and earlier * references to some journals before they were indexed in Index Medicus and MEDLINE, for instance ''Science'', '' BMJ'', and ''Annals of Surg ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ICMJE Recommendations
The ICMJE recommendations (full title, "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals") are a set of guidelines produced by the International Committee of Medical Journal Editors for standardising the ethics, preparation and formatting of manuscripts submitted to biomedical journals for publication. Compliance with the ICMJE recommendations is required by most leading biomedical journals. Levels of real compliance are subject to debate. As of 9 January 2020, 5570 journals worldwide claim to follow the ICMJE recommendations.International Committee of Medical Journal Editors. Journals that have Requested Inclusion on the List of Publications that follow the ICMJE's Uniform Requirements For Manuscripts Submitted to Biomedical Journals omepage on the Internet Philadelphia: ICMJE; c2005 pdated 27 May 2006; cited 30 May 2006 Available from: http://www.icmje.org/journals.html The recommendations were first issued in 1979 und ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States National Library Of Medicine
The United States National Library of Medicine (NLM), operated by the United States federal government, is the world's largest medical library. Located in Bethesda, Maryland, the NLM is an institute within the National Institutes of Health. Its collections include more than seven million books, journals, technical reports, manuscripts, microfilms, photographs, and images on medicine and related sciences, including some of the world's oldest and rarest works. the acting director of the NLM was Stephen Sherry. History The precursor of the National Library of Medicine, established in 1836, was the Library of the Surgeon General's Office, a part of the office of the Surgeon General of the United States Army. The Armed Forces Institute of Pathology and its Medical Museum were founded in 1862 as the Army Medical Museum. Throughout their history the Library of the Surgeon General's Office and the Army Medical Museum often shared quarters. From 1866 to 1887, they were ho ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EudraCT
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European clinical trials database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. The EudraCT database has been established in accordance with Directive 2001/20/EC. The EudraCT Number is unique and is needed on other documents relating to the trials (e.g. SUSAR reports). No new EudraCT numbers are issued since February 2023. They have been replaced by EU CT numbers. Public Side The public side of EudraCT is for organisations to register any of their clinical trials as defined by Directive 2001/20/EC. The process of applying and registering a clinical trial should be completed before submitting an application to any of the Member State/s in which they anticipate running the trial. The public side of EudraCT does not save any of the trial detail entered by the user, and instead provides a saved data file in the form ... [...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] |
