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Preregistration (pharmaceutical)
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 Trial Transparency 2017
Clinical may refer to: Healthcare * Of or about a clinic, a healthcare facility * Of or about the practice of medicine Other uses * Clinical (film), ''Clinical'' (film), a 2017 American horror thriller See also * * * Clinical chemistry, the analysis of bodily fluids for diagnostic and therapeutic purposes * Clinical death, the cessation of blood circulation and breathing * Clinical formulation, a theoretically-based explanation of information obtained from clinical assessment * Clinical governance, a systematic approach to maintaining and improving the quality of patient care * Clinical linguistics, linguistics applied to speech-language pathology * Clinical psychology, the understanding, preventing, and relieving psychologically-based distress or dysfunction * Clinical research, to determine the safety and effectiveness of medications etc. * Clinical significance, the practical importance of a treatment effect * Clinical trial, experiments or observations done in clinical re ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
FDA 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 pharmaceutica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Multiple Comparisons Problem
In statistics, the multiple comparisons, multiplicity or multiple testing problem occurs when one considers a set of statistical inferences simultaneously or infers a subset of parameters selected based on the observed values. The more inferences are made, the more likely erroneous inferences become. Several statistical techniques have been developed to address that problem, typically by requiring a stricter significance threshold for individual comparisons, so as to compensate for the number of inferences being made. History The problem of multiple comparisons received increased attention in the 1950s with the work of statisticians such as Tukey and Scheffé. Over the ensuing decades, many procedures were developed to address the problem. In 1996, the first international conference on multiple comparison procedures took place in Israel. Definition Multiple comparisons arise when a statistical analysis involves multiple simultaneous statistical tests, each of which has a poten ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Center For Open Science
The Center for Open Science is a non-profit technology organization based in Charlottesville, Virginia with a mission to "increase the openness, integrity, and reproducibility of scientific research." Brian Nosek and Jeffrey Spies founded the organization in January 2013, funded mainly by the Laura and John Arnold Foundation and others. The organization began with work in reproducibility of psychology research, with the large-scale initiative Reproducibility Project: Psychology. A second reproducibility project for cancer biology research has also been started through a partnership with Science Exchange. In March 2017, the Center published a detailed strategic plan. Brian Nosek posted a letter outlining the history of the Center and future directions. Open Science Framework Reproducibility project The Open Science Framework (OSF) is an open source software project that facilitates open collaboration in science research. The framework was initially used to work on a project ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Journal Of Personality
The ''European Journal of Personality'' (EJP) is the official bimonthly academic journal of the European Association of Personality Psychology covering research on personality, published by SAGE Publishing. According to citation reports based on impact factor, the journal ranked seventh of all the empirical journals in the social-personality field. EJP seeks to promote the development of empirical and theoretical work in personality psychology. It publishes papers relevant to advancing the field of personality in the broadest sense, and encompasses topics such as the nature of personality, expressions of personality in a social context, personality development, and the consequences of personality. EJP also publishes work on methodological advances in research on personality. It is abstracted inservices including PsycINFO PsycINFO is a database of abstracts of literature in the field of psychology. It is produced by the American Psychological Association and distributed on the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Nature Human Behaviour
''Nature Human Behaviour'' is a monthly multidisciplinary online-only peer-reviewed scientific journal covering all aspects of human behaviour. It was established in January 2017 and is published by Springer Nature Publishing. The editor-in-chief is Stavroula Kousta, Ph.D. According to the ''Journal Citation Reports'', the journal has a 2021 impact factor The impact factor (IF) or journal impact factor (JIF) of an academic journal is a scientometric index calculated by Clarivate that reflects the yearly mean number of citations of articles published in the last two years in a given journal, as i ... of 24.252. References External links * Human behavior Publications established in 2017 Multidisciplinary social science journals Nature Research academic journals Monthly journals Online-only journals English-language journals {{Social-science-journal-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Editor-in-chief
An editor-in-chief (EIC), also known as lead editor or chief editor, is a publication's editorial leader who has final responsibility for its operations and policies. The highest-ranking editor of a publication may also be titled editor, managing editor, or executive editor, but where these titles are held while someone else is editor-in-chief, the editor-in-chief outranks the others. Description The editor-in-chief heads all departments of the organization and is held accountable for delegating tasks to staff members and managing them. The term is often used at newspapers, magazines, yearbooks, and television news programs. The editor-in-chief is commonly the link between the publisher or proprietor and the editorial staff. The term is also applied to academic journals, where the editor-in-chief gives the ultimate decision whether a submitted manuscript will be published. This decision is made by the editor-in-chief after seeking input from reviewers selected on the basis of re ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Psychological Science (journal)
''Psychological Science'', the flagship journal of the Association for Psychological Science (APS), is a monthly, peer-reviewed, scientific journal published by SAGE Publications. Publication scope ''Psychological Science'' publishes research reports and short commentaries. The journal publishes cutting-edge research articles, short reports, and research reports spanning the entire spectrum of the science of psychology. ''Psychological Science'' is a general-interest journal that publishes articles with a general theoretical significance and broad interest across the field of psychological science. The articles include topics from cognitive, social, developmental and health psychology, as well as behavioral neuroscience and biopsychology. The journal also publishes studies that employ novel research methodologies and innovative analysis techniques. Its editor is Patricia Bauer from Emory University, Atlanta, Georgia. Characteristics Published monthly, the journal appears online ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Animal Study Registry
Animal Study Registry is an online registry for the preregistration of research studies involving animals. Animal Study Registry was launched in January 2019 and can be used by scientists worldwide. History The reproducibility of animal test results in biomedical research has been questioned repeatedly in the past. Discussions about this replication crisis have already reached the public. In clinical research, the call for transparency led to the introduction of clinical trial registries that disclose the experimental design of clinical trials before the study is conducted. In order to increase the transparency and the quality in the field of preclinical and basic research, the establishment of so-called centralized animal study registries was suggested. The German Federal Institute for Risk Assessment (BfR), as a scientifically independent research institution, has decided to provide an international freely accessible platform for the pre-registration of studies involving anima ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Declaration Of Helsinki
The Declaration of Helsinki (DoH, fi, Helsingin julistus, sv, Helsingforsdeklarationen) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics. It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations. Its role was described by a Brazilian forum in 2000 in these words: "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity." Principles The Declaration is morally binding on physicians, and that obligation overrides any national or local laws or regulations, if the Declaration provides for a higher standard of protection of humans than the latter ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Uniform Requirements For Manuscripts Submitted To Biomedical Journals
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 un ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration Amendments Act Of 2007
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate. The FDAAA extended the authority to levy fees to companies applying for approval of drugs, expanded clinical trial guidelines for pediatric drugs, and created the priority review voucher program, amongst other items. Title I: Prescription Drug User Fee Amendments of 2007 Title I amends the Federal Food, Drug, and Cosmetic Act to include post-marketing safety activities in the review of drug application. This included developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety probl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
