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104-607: Preregistration can have a number of different goals, including (a) facilitating and documenting research plans, (b) identifying and reducing questionable research practices and researcher biases, (c) distinguishing between confirmatory and exploratory analyses, (d) transparently evaluating the severity of hypothesis tests, and, in the case of Registered Reports, (e) facilitating results-blind peer review, and (f) reducing publication bias. A number of research practices such as p-hacking , publication bias , data dredging , inappropriate forms of post hoc analysis , and HARKing may increase

208-494: A public health emergency of international concern, marking the second such declaration in the last two years due to the virus's transmission. The WHO's Constitution states that its objective "is the attainment by all people of the highest possible level of health". The WHO fulfils this objective through its functions as defined in its Constitution: As of 2012 , the WHO has defined its role in public health as follows: Since

312-540: A significant finding disturbs the balance of findings in favor of positive results. The study of publication bias is an important topic in metascience . Despite similar quality of execution and design , papers with statistically significant results are three times more likely to be published than those with null results . This unduly motivates researchers to manipulate their practices to ensure statistically significant results, such as by data dredging . Many factors contribute to publication bias. For instance, once

416-623: A clinical trials registry. The World Health Organization has begun the push for clinical trial registration with the initiation of the International Clinical Trials Registry Platform . There has also been action from the pharmaceutical industry, which released plans to make clinical trial data more transparent and publicly available. Released in October 2008, the revised Declaration of Helsinki , states that "Every clinical trial must be registered in

520-502: A convention concerning the bubonic plague was signed by sixteen of the nineteen states attending the Venice conference. While Denmark , Sweden-Norway , and the US did not sign this convention, it was unanimously agreed that the work of the prior conferences should be codified for implementation. Subsequent conferences, from 1902 until the final one in 1938, widened the diseases of concern for

624-410: A decline in the magnitude of the overall effect over time. The key feature of time-lag bias tests is that, as more studies accumulate, the mean effect size is expected to converge on its true value. Two meta-analyses of the efficacy of reboxetine as an antidepressant demonstrated attempts to detect publication bias in clinical trials. Based on positive trial data, reboxetine was originally passed as

728-412: A false sense of credibility to research studies and analyses ( Devezer et al., 2020 ; McPhetres, 2020 ; Pham & Oh, 2020 ; Szollosi et al., 2020 ). Consistent with this view, there is some evidence that researchers view registered reports as being more credible than standard reports on a range of dimensions ( Soderberg et al., 2020 ; see also Field et al., 2020 for inconclusive evidence), although it

832-518: A leading role in several public health achievements, most notably the eradication of smallpox , the eradication of polio , and the development of an Ebola vaccine . Its current priorities include communicable diseases , such as HIV/AIDS , Ebola , malaria and tuberculosis ; non-communicable diseases such as heart disease and cancer ; healthy diet , nutrition, and food security ; occupational health ; and substance abuse . The agency advocates for universal health care coverage, engagement with

936-577: A platform which catalogs registered clinical trials. ClinicalTrials.gov , run by the United States National Library of Medicine (NLM) was the first online registry for clinical trials, and remains the largest and most widely used. In addition to combating bias, clinical trial registries serve to increase transparency and access to clinical trials for the public. Clinical trials registries are often searchable (e.g. by disease/indication, drug, location, etc.). Trials are registered by

1040-425: A publicly accessible database before recruitment of the first subject." The World Health Organization maintains an international registry portal at http://apps.who.int/trialsearch/ . WHO states that the international registry's mission is "to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen

1144-621: A registered report, authors create a study proposal that includes theoretical and empirical background, research questions/hypotheses, and pilot data (if available). Upon submission, this proposal will then be reviewed prior to data collection, and if accepted, the paper resulting from this peer-reviewed procedure will be published, regardless of the study outcomes.” Note that only a very small proportion of academic journals in psychology and neurosciences explicitly stated that they welcome submissions of replication studies in their aim and scope or instructions to authors. This phenomenon does not encourage

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1248-540: A resolution on disability prevention and rehabilitation , with a focus on community-driven care. 1977 and 1978: The first list of essential medicines was drawn up, and a year later the ambitious goal of " Health For All " was declared. 1986: The WHO began its global programme on HIV/AIDS . Two years later preventing discrimination against patients was attended to and in 1996 the Joint United Nations Programme on HIV/AIDS (UNAIDS)

1352-429: A resolution passed on the subject, Alger Hiss , the secretary general of the conference, recommended using a declaration to establish such an organization. Sze and other delegates lobbied and a declaration passed calling for an international conference on health. The use of the word "world", rather than "international", emphasized the truly global nature of what the organization was seeking to achieve. The constitution of

1456-421: A scientific finding is well established, it may become newsworthy to publish reliable papers that fail to reject the null hypothesis . Most commonly, investigators simply decline to submit results, leading to non-response bias . Investigators may also assume they made a mistake, find that the null result fails to support a known finding, lose interest in the topic, or anticipate that others will be uninterested in

1560-508: A series of conferences that took place until 1938, about 87 years. The first conference, in Paris, was almost solely concerned with cholera , which would remain the disease of major concern for the ISC for most of the 19th century. With the cause , origin, and communicability of many epidemic diseases still uncertain and a matter of scientific argument, international agreement on appropriate measures

1664-559: A significant infusion of financial and technical resources. The WHO's official mandate is to promote health and safety while helping the vulnerable worldwide. It provides technical assistance to countries, sets international health standards, collects data on global health issues, and serves as a forum for scientific or policy discussions related to health. Its official publication, the World Health Report , provides assessments of worldwide health topics. The WHO has played

1768-403: A study requires careful deliberation about the study's hypotheses, research design and statistical analyses. This depends on the use of pre-registration templates that provides detailed guidance on what to include and why ( Bowman et al., 2016 ; Haven & Van Grootel, 2019 ; Van den Akker et al., 2021 ). Many pre-registration template stress the importance of a power analysis but not only stress

1872-500: A treatment for depression in many countries in Europe and the UK in 2001 (though in practice it is rarely used for this indication). A 2010 meta-analysis concluded that reboxetine was ineffective and that the preponderance of positive-outcome trials reflected publication bias, mostly due to trials published by the drug manufacturer Pfizer . A subsequent meta-analysis published in 2011, based on

1976-401: A type of publication bias, occurs when authors are more likely to submit, or editors are more likely to accept, positive results than negative or inconclusive results. Outcome reporting bias occurs when multiple outcomes are measured and analyzed, but the reporting of these outcomes is dependent on the strength and direction of its results. A generic term coined to describe these post-hoc choices

2080-633: Is HARKing ("Hypothesizing After the Results are Known"). There is extensive meta-research on publication bias in the biomedical field. Investigators following clinical trials from the submission of their protocols to ethics committees (or regulatory authorities) until the publication of their results observed that those with positive results are more likely to be published. In addition, studies often fail to report negative results when published, as demonstrated by research comparing study protocols with published articles. The presence of publication bias

2184-521: Is a specialized agency of the United Nations responsible for global public health . It is headquartered in Geneva , Switzerland, and has six regional offices and 150 field offices worldwide. Only sovereign States can participate, and it is the largest intergovernmental health organization at the international level. The WHO's purpose is to achieve the highest possible level of health for all

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2288-559: Is also supposed to be “a plan, not a prison” ( Dehaven, 2017 ). However, critics counterargue that, if preregistration is only supposed to be a plan, and not a prison, then researchers should feel free to deviate from that plan and undertake exploratory analyses without fearing accusations of low research credibility due to circular reasoning and inappropriate research practices such as p -hacking and unreported multiple testing that leads to inflated familywise error rates (e.g., Navarro, 2020 ). Again, they have pointed out that preregistration

2392-410: Is increasingly reliant on meta-analysis to assess evidence. Meta-analyses and systematic reviews can account for publication bias by including evidence from unpublished studies and the grey literature. The presence of publication bias can also be explored by constructing a funnel plot in which the estimate of the reported effect size is plotted against a measure of precision or sample size. The premise

2496-428: Is not necessary to address such concerns. For example, concerns about p -hacking and unreported multiple testing can be addressed if researchers engage in other open science practices, such as (a) open data and research materials and (b) robustness or multiverse analyses (Rubin, 2020 ; Steegen et al., 2016 ; for several other approaches, see Srivastava, 2018 ). Finally, and more fundamentally, critics have argued that

2600-412: Is not useful to identify or justify deviations from preregistered plans when those plans do not reflect high quality theory and research practice . As Rubin (2020) explained, “we should be more interested in the rationale for the current method and analyses than in the rationale for historical changes that have led up to the current method and analyses” (pp. 378–379). In addition, pre-registering

2704-557: Is now on the verge of extinction, thanks to a Global Vaccination Drive. The World Health Organization (WHO) stated the eradication programme has saved millions from deadly disease. Between 1990 and 2010, WHO's help has contributed to a 40% decline in the number of deaths from tuberculosis, and since 2005, over 46 million people have been treated and an estimated 7 million lives saved through practices advocated by WHO. These include engaging national governments and their financing, early diagnosis, standardising treatment, monitoring of

2808-418: Is still new in preclinical research. A large part of preclinical and basic biomedical research relies on animal experiments. The non-publication of results gained from animal experiments not only distorts the state of research by reinforcing the publication bias, it further represents an ethical issue. Preregistration is discussed as a measure that could counteract this problem. Following registries are suited for

2912-557: Is that the scatter of points should reflect a funnel shape, indicating that the reporting of effect sizes is not related to their statistical significance. However, when small studies are predominately in one direction (usually the direction of larger effect sizes), asymmetry will ensue and this may be indicative of publication bias. Because an inevitable degree of subjectivity exists in the interpretation of funnel plots, several tests have been proposed for detecting funnel plot asymmetry. These are often based on linear regression including

3016-399: Is the practice of documenting clinical trials before they are performed in a clinical trials registry so as to combat publication bias and selective reporting . Registration of clinical trials is required in some countries and is increasingly being standardized. Some top medical journals will only publish the results of trials that have been pre-registered. A clinical trials registry is

3120-524: Is then posted on a publicly available website such as the Open Science Framework or AsPredicted . The preregistered study is then conducted, and a report of the study and its results are submitted for publication together with access to the preregistration document. This preregistration approach allows peer reviewers and subsequent readers to cross-reference the preregistration document with the published research article in order to identify

3224-706: Is to improve the transparency of reported hypothesis tests, which allows readers to evaluate the extent to which decisions during the data analysis were pre-planned (maintaining statistical error control) or data-driven (increasing the Type 1 or Type 2 error rate). Meta-scientific research has revealed additional benefits. Researchers indicate preregistering a study leads to a more carefully thought through research hypothesis, experimental design, and statistical analysis. In addition, preregistration has been shown to encourage better learning of Open Science concepts and students felt that they understood their dissertation and it improved

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3328-454: Is too low. One effect of publication bias is sometimes called the file-drawer effect , or file-drawer problem . This term suggests that negative results, those that do not support the initial hypotheses of researchers are often "filed away" and go no further than the researchers' file drawers, leading to a bias in published research. The term "file drawer problem" was coined by psychologist Robert Rosenthal in 1979. Positive-results bias,

3432-445: Is unclear whether this represents a "false" sense of credibility due to pre-existing positive community attitudes about preregistration or a genuine causal effect of registered reports on quality of research. Publication bias In published academic research , publication bias occurs when the outcome of an experiment or research study biases the decision to publish or otherwise distribute it. Publishing only results that show

3536-480: Is working toward "achieving consensus on both the minimal and the optimal operating standards for trial registration". For many years, scientists and others have worried about reporting biases such that negative or null results from initiated clinical trials may be less likely to be published than positive results, thus skewing the literature and our understanding of how well interventions work. This worry has been international and written about for over 50 years. One of

3640-609: The New England Journal of Medicine , The Lancet , Annals of Internal Medicine , and JAMA ) announced that they would no longer publish results of drug research sponsored by pharmaceutical companies unless that research was registered in a public clinical trials registry database from the start. Furthermore, some journals (e.g. Trials ), encourage publication of study protocols in their journals. The World Health Organization (WHO) agreed that basic information about all clinical trials should be registered at

3744-497: The Center for Open Science . Other proposed strategies to detect and control for publication bias include p-curve analysis and disfavoring small and non-randomized studies due to high susceptibility to error and bias. Publication bias occurs when the publication of research results depends not just on the quality of the research but also on the hypothesis tested, and the significance and direction of effects detected. The subject

3848-498: The FDA Modernization Act of 1997 (Food and Drug Administration Modernization Act of 1997. Pub L No. 105-115, §113 Stat 2296), but the law provided neither funding nor a mechanism of enforcement. In addition, the law required that ClinicalTrials.gov only include trials of serious and life-threatening diseases. Then, two events occurred in 2004 that increased public awareness of the problems of reporting bias. First,

3952-585: The US Centers for Disease Control and Prevention (CDC), the United Nations Children's Fund (UNICEF), and smaller organizations. As of 2011 , it has been working to immunize young children and prevent the re-emergence of cases in countries declared "polio-free". In 2017, a study was conducted as to why Polio Vaccines may not be enough to eradicate the Virus & conduct new technology. Polio

4056-857: The USSR , called on the World Health Assembly to undertake a global initiative to eradicate smallpox, resulting in Resolution WHA11.54. 1965: The first report on diabetes mellitus and the creation of the International Agency for Research on Cancer . 1966: The WHO moved its headquarters from the Ariana wing at the Palace of Nations to a newly constructed headquarters elsewhere in Geneva. 1967: The WHO intensified

4160-1043: The United Nations Development Programme (UNDP), and the World Bank . 1975: The WHO launched the Special Programme for Research and Training in Tropical diseases (the TDR). Co-sponsored by UNICEF , UNDP, and the World Bank, it was established in response to a 1974 request from the WHA for an intensive effort to develop improved control of tropical diseases. The TDR's goals are, firstly, to support and coordinate international research into diagnosis, treatment and control of tropical diseases; and, secondly, to strengthen research capabilities within endemic countries. 1976: The WHA enacted

4264-572: The World Health Assembly finished on 24 July 1948, having secured a budget of US$ 5 million (then £1,250,000 ) for the 1949 year. G. Brock Chisholm was appointed director-general of the WHO, having served as executive secretary and a founding member during the planning stages, while Andrija Štampar was the assembly's first president. Its first priorities were to control the spread of malaria , tuberculosis and sexually transmitted infections , and to improve maternal and child health , nutrition and environmental hygiene. Its first legislative act

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4368-557: The Health Organization of the League of Nations. After World War II , the United Nations absorbed all the other health organizations, to form the WHO. During the 1945 United Nations Conference on International Organization, Szeming Sze , a delegate from China, conferred with Norwegian and Brazilian delegates on creating an international health organization under the auspices of the new United Nations. After failing to get

4472-686: The ISC, and included discussions of responses to yellow fever , brucellosis , leprosy , tuberculosis , and typhoid . In part as a result of the successes of the Conferences, the Pan-American Sanitary Bureau (1902), and the Office International d'Hygiène Publique or " International office of Public Hygiene " in english(1907) were soon founded. When the League of Nations was formed in 1920, it established

4576-667: The United Nations together with the exchange of letters related thereto, and taking into account the respective co-ordinating responsibilities of both organizations, it is recognized by the World Health Organization that the International Atomic Energy Agency has the primary responsibility for encouraging, assisting and co-ordinating research and development and practical application of atomic energy for peaceful uses throughout

4680-483: The WHO over the organization's unwillingness to share the penicillin recipe. They would not return until 1956. 1950: A mass tuberculosis inoculation drive using the BCG vaccine gets under way. 1955: The malaria eradication programme was launched, although objectives were later modified. (In most areas, the programme goals became control instead of eradication.) 1958: Viktor Zhdanov , Deputy Minister of Health for

4784-604: The WHO was to report as to whether RTS,S /AS01, were a viable malaria vaccine . For the time being, insecticide -treated mosquito nets and insecticide sprays are used to prevent the spread of malaria, as are antimalarial drugs – particularly to vulnerable people such as pregnant women and young children. In 1988, WHO launched the Global Polio Eradication Initiative to eradicate polio . It has also been successful in helping to reduce cases by 99% since WHO partnered with Rotary International ,

4888-425: The WHO's role and priorities in public health, ranging from narrowing its mandate to strengthening its independence and authority. During the 1970s, WHO had dropped its commitment to a global malaria eradication campaign as too ambitious, it retained a strong commitment to malaria control. WHO's Global Malaria Programme works to keep track of malaria cases, and future problems in malaria control schemes. As of 2012,

4992-503: The World Health Organization was signed by all 51 countries of the United Nations, and by 10 other countries, on 22 July 1946. It thus became the first specialized agency of the United Nations to which every member subscribed. Its constitution formally came into force on the first World Health Day on 7 April 1948, when it was ratified by the 26th member state. The WHO formally began its work in September 1, 1948. The first meeting of

5096-705: The average correlations were only about half the magnitude of the findings published in Social Issues Management, Business Ethics, or Business and Society journals". One example cited as an instance of publication bias is the refusal to publish attempted replications of Bem's work that claimed evidence for precognition by The Journal of Personality and Social Psychology (the original publisher of Bem's article). An analysis comparing studies of gene-disease associations originating in China to those originating outside China found that those conducted within

5200-577: The basis for global prevention, treatment, and support the plan to fight the AIDS pandemic . 2006: The WHO launches the Global action plan for influenza vaccines 2016: The Global action plan for influenza vaccines ends with a report which concludes that while substantial progress has been made over the 10 years of the Plan, the world is still not ready to respond to an influenza pandemic. 2016: Following

5304-424: The budget and activities. The WHO is funded primarily by contributions from member states (both assessed and voluntary), followed by private donors. Its total approved budget for 2020–2021 is over $ 7.2 billion, while the approved budget for 2022–2023 is over $ 6.2 billion. The budget is $ 6.83 billion for 2024–2025. The International Sanitary Conferences (ISC), the first of which was held on 23 June 1851, were

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5408-485: The clarity of the manuscript writing, promoted rigour and were more likely to avoid questionable research practices. In addition, it becomes a tool that can supervisors can use to shape students to combat any questionable research practices. A 2024 study in the Journal of Political Economy: Microeconomics preregistration in economics journals found that preregistration did not reduce p-hacking and publication bias, unless

5512-559: The conclusions follow from the data. Because studies are accepted for publication regardless of whether the results are statistically significant Registered Reports prevent publication bias. Meta-scientific research has shown that the percentage of non-significant results in Registered Reports is substantially higher than in standard publications. Preregistration can be used in relation to a variety of different research designs and methods, including: Clinical trial registration

5616-627: The continuing effects of nuclear disasters in Chernobyl and Fukushima . They believe WHO must regain what they see as independence. Independent WHO held a weekly vigil from 2007 to 2017 in front of WHO headquarters. However, as pointed out by Foreman in clause 2 it states: In particular, and in accordance with the Constitution of the World Health Organization and the Statute of the International Atomic Energy Agency and its agreement with

5720-764: The country reported a stronger association and a more statistically significant result. John Ioannidis argues that "claimed research findings may often be simply accurate measures of the prevailing bias." He lists the following factors as those that make a paper with a positive result more likely to enter the literature and suppress negative-result papers: Other factors include experimenter bias and white hat bias . Publication bias can be contained through better-powered studies, enhanced research standards, and careful consideration of true and non-true relationships. Better-powered studies refer to large studies that deliver definitive results or test major concepts and lead to low-bias meta-analysis. Enhanced research standards such as

5824-399: The data and that often observations are not fully independent. As of 1998 , "No trial published in China or Russia/USSR found a test treatment to be ineffective." Where publication bias is present, published studies are no longer a representative sample of the available evidence. This bias distorts the results of meta-analyses and systematic reviews . For example, evidence-based medicine

5928-419: The distinction between confirmatory and exploratory analyses is unclear and/or irrelevant ( Devezer et al., 2020 ; Rubin, 2020 ; Szollosi & Donkin, 2019 ), and that concerns about inflated familywise error rates are unjustified when those error rates refer to abstract, atheoretical studywise hypotheses that are not being tested (Rubin, 2020 , 2021 ; Szollosi et al., 2020 ). There are also concerns about

6032-465: The double standard were systematic reviewers, those who summarize what is known from clinical trials. If the literature is skewed, then the results of a systematic review are also likely to be skewed, possibly favoring the test intervention when in fact the accumulated data do not show this, if all data were made public. ClinicalTrials.gov was originally developed largely as a result of breast cancer consumer lobbying, which led to authorizing language in

6136-449: The editorial staff will be asking for replication of studies with surprising findings from examinations using small sample sizes before allowing the manuscripts to be published. Nature Human Behaviour has adopted the registered report format, as it “shift[s] the emphasis from the results of research to the questions that guide the research and the methods used to answer them”. European Journal of Personality defines this format: “In

6240-675: The effect size, statistical power, and magnitude. The prevalence of publication bias distorted confidence in meta-analytic results, with 66% of initially statistically significant meta-analytic means becoming non-significant after correcting for publication bias. Ecological and evolutionary studies consistently had low statistical power (15%) with a 4-fold exaggeration of effects on average (Type M error rates = 4.4). The presence of publication bias can be detected by Time-lag bias tests, where time-lag bias occurs when larger or statistically significant effects are published more quickly than smaller or non-statistically significant effects. It can manifest as

6344-614: The establishment of international standards for biological products. The WHO was established on April 7, 1948, and formally began its work on September 1, 1948. It incorporated the assets, personnel, and duties of the League of Nations ' Health Organization and the Paris-based Office International d'Hygiène Publique , including the International Classification of Diseases (ICD). The agency's work began in earnest in 1951 after

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6448-601: The fiftieth anniversary of WHO's founding. He, did, however, accept that more had to be done to assist maternal health and that progress in this area had been slow. 2000: The Stop TB Partnership was created along with the UN's formulation of the Millennium Development Goals . 2001: The measles initiative was formed, and credited with reducing global deaths from the disease by 68% by 2007. 2002: The Global Fund to Fight AIDS, Tuberculosis and Malaria

6552-488: The file-drawer problem if it were the sole focus of a contemplated paper. For the same reason, the megastudy research design may encourage researchers to study not only the interventions they consider more likely to be effective but also those interventions that researchers are less sure about and that they would not pick as the sole focus of the study due to the perceived high risk of a null effect. World Health Organization The World Health Organization ( WHO )

6656-401: The findings is provisionally guaranteed (in principle acceptance). The proposed study is then performed, and the research report is submitted for Stage 2 peer review. Stage 2 peer review confirms that the actual research methods are consistent with the preregistered protocol, that quality thresholds are met (e.g., manipulation checks confirm the validity of the experimental manipulation), and that

6760-500: The former has a power analysis and higher sample size than the latter but other than that they do not seem to prevent p-hacking and HARKing, as both the proportion of positive results and effect sizes are similar between preregistered and non-preregistered studies ( Van den Akker et al., 2023 ). In addition, a survey of 27 preregistered studies found that researchers deviated from their preregistered plans in all cases ( Claesen et al., 2019 ). The most frequent deviations were with regards to

6864-449: The global smallpox eradication campaign by contributing $ 2.4 million annually to the effort and adopted a new disease surveillance method, at a time when 2 million people were dying from smallpox per year. The initial problem the WHO team faced was inadequate reporting of smallpox cases. WHO established a network of consultants who assisted countries in setting up surveillance and containment activities. The WHO also helped contain

6968-403: The importance of why the methodology was used. Additionally to the concerns raised about its practical implementation in quantitative research, critics have also argued that preregistration is less applicable, or even unsuitable, for qualitative research. Pre-registration imposes rigidity, limiting researchers' ability to adapt to emerging data and evolving contexts, which are essential to capturing

7072-536: The last European outbreak in Yugoslavia in 1972 . After over two decades of fighting smallpox, a Global Commission declared in 1979 that the disease had been eradicated – the first disease in history to be eliminated by human effort. 1974: The Expanded Programme on Immunization and the control programme of onchocerciasis was started, an important partnership between the Food and Agriculture Organization (FAO),

7176-453: The late 20th century, the rise of new actors engaged in global health—such as the World Bank , the Bill & Melinda Gates Foundation, the U.S. President's Emergency Plan for AIDS Relief ( PEPFAR ) and dozens of public-private partnerships for global health—have weakened the WHO's role as a coordinator and policy leader in the field; subsequently, there are various proposals to reform or reorient

7280-477: The monitoring of public health risks, coordinating responses to health emergencies, and promoting health and well-being generally. The WHO is governed by the World Health Assembly (WHA), which is composed of its 194 member states. The WHA elects and advises an executive board made up of 34 health specialists; selects the WHO's chief administrator, the director-general (currently Tedros Adhanom Ghebreyesus of Ethiopia ); sets goals and priorities; and approves

7384-605: The most important motivator for trial registration, as investigators wanted to reserve the possibility that they could publish their results in prestigious journals, should they want to. In 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) clarified the requirements for registration and also set penalties for non-compliance (Public Law 110-85. The Food and Drug Administration Amendments Act of 2007 [1] . The International Committee of Medical Journal Editors (ICMJE) decided that from July 1, 2005 no trials will be considered for publication unless they are included on

7488-711: The null results. The nature of these issues and the resulting problems form the five diseases that threaten science: " significosis , an inordinate focus on statistically significant results; neophilia , an excessive appreciation for novelty; theorrhea , a mania for new theory; arigorium , a deficiency of rigor in theoretical and empirical work; and finally, disjunctivitis , a proclivity to produce many redundant, trivial, and incoherent works." Attempts to find unpublished studies often prove difficult or are unsatisfactory. In an effort to combat this problem, some journals require studies submitted for publication pre-register (before data collection and analysis) with organizations like

7592-706: The observed data ( Nosek et al., 2018 , p. 2600). However, critics have argued that preregistration is not necessary to identify circular reasoning during exploratory analyses ( Rubin, 2020 ). Circular reasoning can be identified by analysing the reasoning per se without needing to know whether that reasoning was preregistered. Critics have also noted that the idea that preregistration improves research credibility may deter researchers from undertaking non-preregistered exploratory analyses ( Coffman & Niederle, 2015 ; see also Collins et al., 2021, Study 1 ). In response, preregistration advocates have stressed that exploratory analyses are permitted in preregistered studies, and that

7696-441: The original data, found flaws in the 2010 analyses and suggested that the data indicated reboxetine was effective in severe depression (see Reboxetine § Efficacy ). Examples of publication bias are given by Ben Goldacre and Peter Wilmshurst . In the social sciences, a study of published papers exploring the relationship between corporate social and financial performance found that "in economics, finance, and accounting journals,

7800-421: The other organization has or may have a substantial interest, the first party shall consult the other with a view to adjusting the matter by mutual agreement. The nature of this statement has led some groups and activists including Women in Europe for a Common Future to claim that the WHO is restricted in its ability to investigate the effects on human health of radiation caused by the use of nuclear power and

7904-564: The perceived failure of the response to the West Africa Ebola outbreak , the World Health Emergencies programme was formed, changing the WHO from just being a "normative" agency to one that responds operationally to health emergencies. 2020: the World Health Organization announced that it had classified the novel coronavirus outbreak as a public health emergency of international concern. The novel coronavirus

8008-477: The pharmaceutical, biotech or medical device company (Sponsor) or by the hospital or foundation which is sponsoring the study, or by another organization, such as a contract research organization (CRO) which is running the study. There has been a push from governments and international organizations, especially since 2005, to make clinical trial information more widely available and to standardize registries and processes of registering. The World Health Organization

8112-541: The planned sample size, exclusion criteria, and statistical model. Hence, what were intended as preregistered confirmatory tests ended up as unplanned exploratory tests. Again, preregistration advocates argue that deviations from preregistered plans are acceptable as long as they are reported transparently and justified. They also point out that even vague preregistrations help to reduce researcher degrees of freedom and make any residual flexibility transparent ( Simmons et al., 2021, p. 180 ). However, critics have argued that it

8216-436: The popular Eggers regression test, and may adopt a multiplicative or additive dispersion parameter to adjust for the presence of between-study heterogeneity. Some approaches may even attempt to compensate for the (potential) presence of publication bias, which is particularly useful to explore the potential impact on meta-analysis results. In ecology and environmental biology, a study found that publication bias impacted

8320-577: The practical implementation of preregistration. Many preregistered protocols leave plenty of room for p -hacking ( Bakker et al., 2020 ; Heirene et al., 2021 ; Ikeda et al., 2019 ; Singh et al., 2021 ; Van den Akker et al., 2023 ), and researchers rarely follow the exact research methods and analyses that they preregister ( Abrams et al., 2020 ; Claesen et al., 2019 ; Heirene et al., 2021 ; see also Boghdadly et al., 2018 ; Singh et al., 2021 ; Sun et al., 2019 ). For example, pre-registered studies are only of higher quality than non-pre-registered studies if

8424-576: The pre-registration of protocols, the registration of data collections, and adherence to established protocols are other techniques. To avoid false-positive results, the experimenter must consider the chances that they are testing a true or non-true relationship. This can be undertaken by properly assessing the false positive report probability based on the statistical power of the test and reconfirming (whenever ethically acceptable) established findings of prior studies known to have minimal bias. In September 2004, editors of prominent medical journals (including

8528-431: The preregistration of preclinical studies. Over 200 journals offer a registered reports option ( Centre for Open Science, 2019 ), and the number of journals that are adopting registered reports is approximately doubling each year ( Chambers et al., 2019 ). Psychological Science has encouraged the preregistration of studies and the reporting of effect sizes and confidence intervals. The editor-in-chief also noted that

8632-675: The preregistration was accompanied by a preanalysis plan. Proponents of preregistration have argued that it is "a method to increase the credibility of published results" ( Nosek & Lakens, 2014 ), that it "makes your science better by increasing the credibility of your results" ( Centre for Open Science ), and that it "improves the interpretability and credibility of research findings" ( Nosek et al., 2018 , p. 2605). This argument assumes that non-preregistered exploratory analyses are less "credible" and/or "interpretable" than preregistered confirmatory analyses because they may involve "circular reasoning" in which post hoc hypotheses are based on

8736-507: The presence of any undisclosed deviations of the preregistration. Deviations from the preregistration are possible and common in practice, but they should be transparently reported, and the consequences for the severity of the test should be evaluated. The registered report format requires authors to submit a description of the study methods and analyses prior to data collection. Once the theoretical introduction, method, and analysis plan has been peer reviewed (Stage 1 peer review), publication of

8840-677: The probability of incorrect claims. Although the idea of preregistration is old, the practice of preregistering studies has gained prominence to mitigate to some of the issues that are thought to underlie the replication crisis . In the standard preregistration format, researchers prepare a research protocol document prior to conducting their research. Ideally, this document indicates the research hypotheses, sampling procedure, sample size, research design, testing conditions, stimuli, measures, data coding and aggregation method, criteria for data exclusions, and statistical analyses, including potential variations on those analyses. This preregistration document

8944-459: The proposals to address this potential bias was a comprehensive register of initiated clinical trials that would inform the public which trials had been started. Ethical issues were those that seemed to interest the public most, as trialists (including those with potential commercial gain) benefited from those who enrolled in trials, but were not required to “give back,” telling the public what they had learned. Those who were particularly concerned by

9048-425: The reporting or even attempt on replication studies. Overall, the number of participating journals is increasing, as indicated by the Center for Open Science , which maintains a list of journals encouraging the submission of registered reports. Several articles have outlined the rationale for preregistration (e.g., Lakens, 2019 ; Nosek et al., 2018 ; Wagenmakers et al., 2012 ). The primary goal of preregistration

9152-410: The reporting standards of their registry. Worldwide, there is growing number of registries. A 2013 study identified the following top five registries (numbers updated as of August 2013): Similar to clinical research, preregistration can help to improve transparency and quality of research data in preclinical research. In contrast to clinical research where preregistration is mandatory for vast parts it

9256-410: The results of these analyses retain some value vis-a-vis hypothesis generation rather than hypothesis testing. Preregistration merely makes the distinction between confirmatory and exploratory research clearer ( Nosek et al., 2018 ; Nosek & Lakens, 2014 ; Wagenmakers et al., 2012 ). Hence, although preregistraton is supposed to reduce researcher degrees of freedom during the data analysis stage, it

9360-428: The richness of participants' lived experiences ( Souza-Neto & Moyle, 2025 ). Additionally, it conflicts with the inductive and flexible nature of theory-building in qualitative research, constraining the exploratory approach that is central to this methodology ( Souza-Neto & Moyle, 2025 ). Finally, some commentators have argued that, under some circumstances, preregistration may actually harm science by providing

9464-515: The study's inception and that this information should be publicly accessible through the WHO International Clinical Trials Registry Platform . Additionally, the public availability of complete study protocols, alongside reports of trials, is becoming more common for studies. In a megastudy, a large number of treatments are tested simultaneously. Given the inclusion of different interventions in

9568-403: The study, a megastudy's publication likelihood is less dependent on the statistically significant effect of any specific treatment, so it has been suggested that megastudies may be less prone to publication bias. For example, an intervention found to be ineffective would be easier to publish as part of a megastudy as just one of many studied interventions. In contrast, it might go unreported due to

9672-486: The then-New York State Attorney General Eliot Spitzer sued GlaxoSmithKline (GSK) because they had failed to reveal results from trials showing that certain antidepressants might be harmful. Shortly thereafter, the International Committee of Medical Journal Editors (ICMJE) announced that their journals would not publish reports of trials unless they had been registered. The ICMJE action was probably

9776-441: The validity and value of the scientific evidence base." Since 2007, the International Committee of Medical Journal Editors ICMJE accepts all primary registries in the WHO network in addition to clinicaltrials.gov. Clinical trial registration in other registries excluding ClinicalTrials.gov has increased irrespective of study designs since 2014. Various studies have measured the extent to which various trials are in compliance with

9880-488: The world without prejudice to the right of the World Health Organization to concern itself with promoting, developing, assisting and co-ordinating international health work, including research, in all its aspects. The key text is highlighted in bold, the agreement in clause 2 states that the WHO is free to perform any health-related work. 1947: The WHO established an epidemiological information service via telex . 1949: The Soviet Union and its constituent republics quit

9984-407: The world's people, defining health as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." The main functions of the World Health Organization include: to promote the control of epidemic and endemic diseases; to provide and improve the teaching and training in public health, the medical treatment of disease and related matters; and to promote

10088-513: Was a new strain of coronavirus that had never been detected in humans before. The WHO named this new coronavirus " COVID-19 " or "2019-nCov". 2022: The WHO suggests formation of a Global Health Emergency Council, with a new global health emergency workforce, and recommends revision of the International Health Regulations. 2024: WHO has declared the spread of mpox (formerly monkeypox) in several African countries

10192-543: Was concerning the compilation of accurate statistics on the spread and morbidity of disease. The logo of the World Health Organization features the Rod of Asclepius as a symbol for healing. In 1959, the WHO signed Agreement WHA 12–40 with the International Atomic Energy Agency (IAEA), which says: whenever either organization proposes to initiate a programme or activity on a subject in which

10296-475: Was difficult to reach. Seven of these international conferences, spanning 41 years, were convened before any resulted in a multi-state international agreement. The seventh conference, in Venice in 1892, finally resulted in a convention. It was concerned only with the sanitary control of shipping traversing the Suez Canal , and was an effort to guard against importation of cholera. Five years later, in 1897,

10400-416: Was drawn up to improve the resources available. 2005: The WHO revises International Health Regulations (IHR) in light of emerging health threats and the experience of the 2002/3 SARS epidemic , authorizing WHO, among other things, to declare a health threat a Public Health Emergency of International Concern . 2006: The WHO endorsed the world's first official HIV/AIDS Toolkit for Zimbabwe, which formed

10504-428: Was first discussed in 1959 by statistician Theodore Sterling to refer to fields in which "successful" research is more likely to be published. As a result, "the literature of such a field consists in substantial part of false conclusions resulting from errors of the first kind in statistical tests of significance". In the worst case, false conclusions could canonize as being true if the publication rate of negative results

10608-705: Was formed. 1988: The Global Polio Eradication Initiative was established. 1995: The WHO established an independent International Commission for the Certification of Dracunculiasis Eradication (Guinea worm disease eradication; ICCDE). The ICCDE recommends to the WHO which countries fulfil requirements for certification. It also has role in advising on progress made towards elimination of transmission and processes for verification. 1998: The WHO's director-general highlighted gains in child survival, reduced infant mortality , increased life expectancy and reduced rates of "scourges" such as smallpox and polio on

10712-419: Was found in meta-analyses published in prominent medical journals. Meta-analyses (reviews) have been performed in the field of ecology and environmental biology. In a study of 100 meta-analyses in ecology, only 49% tested for publication bias. While there are multiple tests that have been developed to detect publication bias, most perform poorly in the field of ecology because of high levels of heterogeneity in

10816-601: Was investigated in meta-analyses . The largest such analysis investigated the presence of publication bias in systematic reviews of medical treatments from the Cochrane Library . The study showed that statistically positive significant findings are 27% more likely to be included in meta-analyses of efficacy than other findings. Results showing no evidence of adverse effects have a 78% greater probability of inclusion in safety studies than statistically significant results showing adverse effects. Evidence of publication bias

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