Category Archives: oa.who

Open Source Programme Offices (OSPOs) in the UN System – A Spotlight on WHO. 15-16 September 2022 | 77th United Nations General Assembly (UNGA)

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“…Our first side-event will cover the highly anticipated launch of the Open Source Programme Office (OSPO) at the World Health Organization, which is the first OSPO in the entire UN system. Panelists from WHO, GitHub, and the United Nations Envoy on Technology will discuss the technical aspects and the vision of the WHO OSPO, why an OSPO is a major step forward for how WHO engages with open source technologies, and how an OSPO in the UN system can contribute to more equitable technology and inclusive economic growth….”

hosted by GitHub Social Impact, Tech for Social Good 

 

Adoption of World Health Organization Best Practices in Clinical Trial Transparency Among European Medical Research Funder Policies | Global Health | JAMA Network Open | JAMA Network

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Abstract:  Importance  Research funders can reduce research waste and publication bias by requiring their grantees to register and report clinical trials.

Objective  To determine the extent to which 21 major European research funders’ efforts to reduce research waste and publication bias in clinical trials meet World Health Organization (WHO) best practice benchmarks and to investigate areas for improvement.

Design, Setting, and Participants  This cross-sectional study was based on 2 to 3 independent assessments of each funder’s publicly available documentation and validation of results with funders during 2021. Included funders were the 21 largest nonmultilateral public and philanthropic medical research funders in Europe, with a combined budget of more than US $22 billion.

Exposures  Scoring of funders using an 11-item assessment tool based on WHO best practice benchmarks, grouped into 4 broad categories: trial registries, academic publication, monitoring, and sanctions. Funder references to reporting standards were captured.

Main Outcomes and Measures  The primary outcome was funder adoption or nonadoption of 11 policy and monitoring measures to reduce research waste and publication bias as set out by WHO best practices. The secondary outcomes were whether and how funder policies referred to reporting standards. Outcomes were preregistered after a pilot phase that used the same outcome measures.

Results  Among 21 of the largest nonmultilateral public and philanthropic funders in Europe, some best practices were more widely adopted than others, with 14 funders (66.7%) mandating prospective trial registration and 6 funders (28.6%) requiring that trial results be made public on trial registries within 12 months of trial completion. Less than half of funders actively monitored whether trials were registered (9 funders [42.9%]) or whether results were made public (8 funders [38.1%]). Funders implemented a mean of 4 of 11 best practices in clinical trial transparency (36.4%) set out by WHO. The extent to which funders adopted WHO best practice items varied widely, ranging from 0 practices for the French Centre National de la Recherche Scientifique and the ministries of health of Germany and Italy to 10 practices (90.9%) for the UK National Institute of Health Research. Overall, 9 funders referred to reporting standards in their policies.

Conclusions and Relevance  This study found that many European medical research funder policy and monitoring measures fell short of WHO best practices. These findings suggest that funders worldwide may need to identify and address gaps in policies and processes.

Medical research funders across Europe tighten rules on clinical trial reporting

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“Eight of the 21 largest public and philanthropic medical research funders in Europe are stepping up their efforts to improve clinical reporting, following an assessment that found widespread gaps in existing research waste safeguards.

 

 

 

At present, many academic clinical trials in Europe fail to make their results public, wasting taxpayers’ money and leaving large gaps in the medical evidence base.

 

 

 

The public institutions that hand out money to medical researchers can prevent such waste by putting into place eleven safeguards recommended by the World Health Organisation. …”

WHA clinical trial resolution: draft text now public

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“The World Health Organization today published the draft text of the clinical trial resolution being debated at the ongoing World Health Assembly.

 

 

The resolution’s overall aim is to improve the coordination, design, conduct and reporting of clinical trials worldwide. It was partly spurred by the realisation that hundreds – maybe thousands – of Covid clinical trials have ended up as costly research waste….

 

Promoting, as appropriate, measures to facilitate the timely reporting of both positive and negative interpretable clinical trial results in alignment with the WHO joint statement on public disclosure of results from clinical trials and the WHO joint statement on transparency and data integrity, including through registering the results on a publicly available clinical trial registry within the [global trial registry network] ICTRP, and encouraging timely publication of the trial results preferably in an open-access publication.

Exploring measures during public health emergencies of international concern to encourage researchers to rapidly and responsibly share interpretable results of clinical trials, including negative results, with national regulatory bodies or other appropriate authorities, including WHO for clinical guideline development and emergency use listing (EUL), to support rapid regulatory decision-making and emergency adaptation of clinical and public health guidelines as appropriate, including through pre-print publication. …”

 

Why did clinical trial registries fail to prevent Covid research chaos?

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“There is a long-standing global ethical obligation to register all trials before they start, shored up by regulatory requirements in some jurisdictions. Data from 18 registries worldwide feed into the WHO-managed International Clinical Trials Registry Platform (ICTRP), providing a continuously updated overview of who is researching what, when, where and how – at least in theory.

 

 

If the registry infrastructure had worked and been used as intended, much of the COVID-19 research chaos would have been avoided.

 

 

For example, researchers considering launching a hydroxychloroquine trial could have searched ICTRP and discovered that the drug was already being investigated by numerous other trials. Those researchers could accordingly have focused on investigating other treatment options instead, or aligned their outcome measures with existing trials. …

The global registry infrastructure has long been inadequately supported by legislators and regulators, and is woefully underfunded.

 

 

 

This persistent neglect of the world’s only comprehensive directory of medical research led to costly research waste on an incredible scale during the pandemic.

 

 

The WHO recommends that member states should by law require every interventional trial to be registered and reported. In addition, WHO recommends that all trial results should be made public specifically on a registry within 12 months, and that registry data should be kept up to date.

 

 

 

By enforcing these three simple rules, regulators would ensure that there is a comprehensive, up-to-date global database of all trials and their results.

 

In reality, existing laws in the EU and the US only cover a small minority of trials and are not being effectively enforced, while many other jurisdictions have no relevant laws at all. …”

 

 

WHA 75: UK draft resolution on Strengthening Clinical Trials to Improve Public Health – Knowledge Ecology International

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“On 30 March 2022, Knowledge Ecology International (KEI) published the text of the draft resolution on social media. The text of the UK draft resolution on Strengthening Clinical Trials to Improve Public Health can be found here: Strengthening Clinical Trials to Improve Public Health – zero draft …”

Open Access Publishing: Issues and Way Forward – Predatory Journals and Conferences

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“One of the major challenges the world has faced the past two years has been the onset of the COVID-19 pandemic. With scientists putting up lot of research on COVID, the World Health Organization (WHO) came up with a WHO: COVID-19 Literature on corona virus disease. This database provides a way for the general public, along with scientists, to check the scientific literature on COVID-19, in one place, and this also results in wider reach/dissemination.

However, we do not have a common database for other important research areas concerning the general public, such as “Cancer Research” or “Climate Change”. When we say open access, the main aim should be open science to all, and we need more such databases by international agencies like the United Nations to collate research articles on important areas such as the 17 UN Sustainable Development Goals, which should be the need of the hour. Such initiatives will help in the real dissemination of science to the general public, and give authors of important research contributions, the visibility they deserve. This will be unlike publishers asking authors to promote their articles and measuring them with their commercial metrics….”

Changes in Users Trends Before and During the COVID-19 Pandemic on WHO’s Online Learning Platform

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Abstract:  OpenWHO provides open access, online, free and real time learning responses to health emergencies. Before the pandemic, courses on 18 diseases were provided. The increase to 38 courses in response to COVID-19 have led to a massive increase in the number of new learners. As a result, the COVID-19 pandemic affected learners’ trends. This paper presents initial findings of changes perceived in the use and user groups’ attendance to the World Health Organization’s (WHO) health emergency learning platform OpenWHO. Enrolment statistics were based on data collected in December 2019 and March 2021. A descriptive analysis was conducted to explore changes in the usage pattern of the platform. Several user characteristics shifted between before and during the pandemic. More women, younger and older learners joined the learning during the pandemic. Public health education leaned toward a more equitable reach including previously underrepresented groups.

 

WHO starts data-sharing effort to prevent pandemics. Will nations cooperate? | South China Morning Post

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“WHO Hub for Pandemic and Epidemic Intelligence opens in Berlin backed by initial US$100 million from Germany

It aims to pool global disease data, and produce tools to predict outbreaks – but is reliant on countries taking part.”

Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO

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“ICMRA1 and WHO call on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines (whether full or conditional approval, under emergency use, or rejected). Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest….

Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted. In any case, aggregated data are unlikely to lead to re-identification of personal data and techniques of anonymisation can be used….

 

Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada. The COVID-19 pandemic has revealed how essential to public trust access to data is. ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health.”

 

 

Completeness of open access FluNet influenza surveillance data for Pan-America in 2005–2019 | Scientific Reports

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Abstract:  For several decades, the World Health Organization has collected, maintained, and distributed invaluable country-specific disease surveillance data that allow experts to develop new analytical tools for disease tracking and forecasting. To capture the extent of available data within these sources, we proposed a completeness metric based on the effective time series length. Using FluNet records for 29 Pan-American countries from 2005 to 2019, we explored whether completeness was associated with health expenditure indicators adjusting for surveillance system heterogeneity. We observed steady improvements in completeness by 4.2–6.3% annually, especially after the A(H1N1)-2009 pandemic, when 24 countries reached?>?95% completeness. Doubling in decadal health expenditure per capita was associated with?~?7% increase in overall completeness. The proposed metric could navigate experts in assessing open access data quality and quantity for conducting credible statistical analyses, estimating disease trends, and developing outbreak forecasting systems.

 

Vigilance for Medical Products of Human Origin—Progress on t… : Transplantation

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Abstract:  World Health Assembly Resolution WHA 63.22 mandated WHO to facilitate Member State access to appropriate information on Medical Products of Human Origin (MPHO), including collecting data on serious adverse events and reactions. To meet this challenge, the Italian National Transplant Center, with a mandate from WHO, has built and maintains an open access searchable database of instructive records on disease transmission and other MPHO adverse occurrences.

 

Reducing bias and improving transparency in medical research: a critical overview of the problems, progress and suggested next steps – Stephen H Bradley, Nicholas J DeVito, Kelly E Lloyd, Georgia C Richards, Tanja Rombey, Cole Wayant, Peter J Gill, 2020

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Abstract:  In recent years there has been increasing awareness of problems that have undermined trust in medical research. This review outlines some of the most important issues including research culture, reporting biases, and statistical and methodological issues. It examines measures that have been instituted to address these problems and explores the success and limitations of these measures. The paper concludes by proposing three achievable actions which could be implemented to deliver significantly improved transparency and mitigation of bias. These measures are as follows: (1) mandatory registration of interests by those involved in research; (2) that journals support the ‘registered reports’ publication format; and (3) that comprehensive study documentation for all publicly funded research be made available on a World Health Organization research repository. We suggest that achieving such measures requires a broad-based campaign which mobilises public opinion. We invite readers to feedback on the proposed actions and to join us in calling for their implementation.

 

Reducing bias and improving transparency in medical research: a critical overview of the problems, progress and suggested next steps – Stephen H Bradley, Nicholas J DeVito, Kelly E Lloyd, Georgia C Richards, Tanja Rombey, Cole Wayant, Peter J Gill, 2020

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Abstract:  In recent years there has been increasing awareness of problems that have undermined trust in medical research. This review outlines some of the most important issues including research culture, reporting biases, and statistical and methodological issues. It examines measures that have been instituted to address these problems and explores the success and limitations of these measures. The paper concludes by proposing three achievable actions which could be implemented to deliver significantly improved transparency and mitigation of bias. These measures are as follows: (1) mandatory registration of interests by those involved in research; (2) that journals support the ‘registered reports’ publication format; and (3) that comprehensive study documentation for all publicly funded research be made available on a World Health Organization research repository. We suggest that achieving such measures requires a broad-based campaign which mobilises public opinion. We invite readers to feedback on the proposed actions and to join us in calling for their implementation.

 

The World Health Organization and Wikimedia Foundation expand access to trusted information about COVID-19 on Wikipedia

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“The World Health Organization (WHO) and the Wikimedia Foundation, the nonprofit that administers Wikipedia, announced today a collaboration to expand the public’s access to the latest and most reliable information about COVID-19. 

The collaboration will make trusted, public health information available under the Creative Commons Attribution-ShareAlike license at a time when countries face continuing resurgences of COVID-19 and social stability increasingly depends on the public’s shared understanding of the facts. 

Through the collaboration, people everywhere will be able to access and share WHO infographics, videos, and other public health assets on Wikimedia Commons, a digital library of free images and other multimedia. 

With these new freely-licensed resources, Wikipedia’s more than 250,000 volunteer editors can also build on and expand the site’s COVID-19 coverage, which currently offers more than 5,200 coronavirus-related articles in 175 languages. This WHO content will also be translated across national and regional languages through Wikipedia’s vast network of global volunteers.”