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Clinicaltrials.gov
ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and is the largest clinical trials database, holding registrations from over 329,000 trials from 209 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 pu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trials Registry
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 Stan ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trials Registry
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 Stan ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Deborah Zarin
Deborah Zarin is a program director at the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard University. She was formerly a scientist at the National Institutes of Health and the director of ClinicalTrials.gov. Zarin has a reputation as an advocate for open data. In 2014 Zarin accepted a visiting scholar appointment at the Stanford University School of Medicine to research the quality of scientific investigations. Bibliography * Is a Trial For You?, an article from 2005 in ''The Washington Post ''The Washington Post'' (also known as the ''Post'' and, informally, ''WaPo'') is an American daily newspaper published in Washington, D.C. It is the most widely circulated newspaper within the Washington metropolitan area and has a large nati ...'' * * References External linksprofile at NIH [...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 va ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration Modernization Act Of 1997
The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes were made in order to recognize the changes in the way the FDA would be operating in the 21st century. The main focus of this is the acknowledgment in the advancement of technological, trade, and public health complexities. 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 Food and Drug Administration Modernization Act of 1997. The U.S. legislation was signed by Bill Clinton on 21 November 1997, and was fully enacted by 1 April 1999, putting into law reforms begun under the National Partnership for Reinventing Government. One result of the passing of the act was a reduction in the time for the approval of new pharmaceutic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Events
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. 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, birth defect or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are ... [...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 current director of the NLM is Patricia Flatley Brennan.National Library of Medicine Welcomes New Director Dr. Patricia Flatley Brennan . ''National Library of Medicine''. August 15, 2016. History The precur ...[...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
PubMed
PubMed is a free search engine accessing 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 maintain the database as part of the Entrez system of information retrieval. From 1971 to 1997, online access to the MEDLINE database had been 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 Surgery'' * very recent entries to records for an article be ... [...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 fromhttp://www.icmje.org/journals.html/ref> The recommendations were first issued in 1979 und ... [...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 source registries: * 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 * Clinical Tri ... [...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 current director of the NLM is Patricia Flatley Brennan.National Library of Medicine Welcomes New Director Dr. Patricia Flatley Brennan . ''National Library of Medicine''. August 15, 2016. History The precurso ...[...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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