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

“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. …”

 

 

Changing dynamics of scholarly publication: a perspective towards open access publishing and the proposed one nation, one subscription policy of India

Abstract:  In the midst of the most widely used subscription-based publishing model, open access publishing is gaining a foothold in the publishing world. India, as one of the world’s leading producers of scientific information, has seen a considerable escalation in the production of open access knowledge content, which has sparked a scholarly debate towards the availability and accessibility of scholarly knowledge to all. Despite the fact that two major science funding agencies of India, the Department of Science and Technology and Department of Biotechnology, adopted an open access policy in 2014 to promote green open access to articles produced from publicly financed research projects, academic content still remains out of reach for everyone due to inadequate planning and implementation. Recently the Government of India has proposed a “one nation, one subscription” (ONOS) policy to make scholarly knowledge more accessible to Indian citizens. The study’s primary goal is to look into the open-access situation across many subject groups in India and globally. The aim is to understand whether a blanket subscription policy is the best way to facilitate the accessibility of scholarly knowledge or if subject-specific needs implications of other global OA initiatives are worth considering when implementing the ONOS policy.

Data and Software for Authors | AGU

“AGU requires that the underlying data needed to understand, evaluate, and build upon the reported research be available at the time of peer review and publication. Additionally, authors should make available software that has a significant impact on the research. This entails:

Depositing the data and software in a community accepted, trusted repository, as appropriate, and preferably with a DOI
Including an Availability Statement as a separate paragraph in the Open Research section explaining to the reader where and how to access the data and software
And including citation(s) to the deposited data and software, in the Reference Section….”

Which solutions best support sharing and reuse of code? – The Official PLOS Blog

“PLOS has released a preprint and supporting data on research conducted to understand the needs and habits of researchers in relation to code sharing and reuse as well as to gather feedback on prototype code notebooks and help determine strategies that publishers could use to increase code sharing.

Our previous research led us to implement a mandatory code sharing policy at PLOS Computational Biology in March 2021 to increase the amount of code shared alongside published articles. As well as exploring policy to support code sharing, we have also been collaborating with NeuroLibre, an initiative of the Canadian Open Neuroscience Platform, to learn more about the potential role of technological solutions for enhancing code sharing. Neurolibre is one of a growing number of interactive or executable technologies for sharing and publishing research, some of which have become integrated with publishers’ workflows….”

UK regulatory overhaul aims to make publication of clinical trial results a legal requirement

“The UK’s medicines regulator is planning to make the registration of clinical trial results and publication of their results a legal requirement as part of a wider overhaul of UK clinical trial regulation.

 

 

Regulator MHRA proposes to enshrine three transparency requirements in law:

 

 

Trials must be registered

Trial results must be made public within 12 months of trial end

Trial participants must be informed of trial results…”

Accelerating Open Research: A Multi-stakeholder Discussion – The Scholarly Kitchen

“As we move through a transition to a fully open research environment, there are challenges for all stakeholders in the ecosystem. Many funders have taken a leadership role in driving this transition, yet even with funder mandates in place for nearly two decades, the transition to open research globally has been slow (Larivière and Sugimoto, 2018). 

A recent study led by the Research on Research Institute (Waltman et al., 2021 ) found that commitments to open research and data sharing fell short during the pandemic and that lack of collaboration was a key factor. 

On the 10th February 2022, the Society for Scholarly Publishing (SSP) Publisher-Funder Task Force convened a closed forum of funders, publishers, librarians and academics to discuss how collaborating among stakeholder groups may accelerate a transition to open research. The meeting was conducted under the Chatham House Rule, enabling 22 international participants to freely express opinions and ideas without fear of comments being attributed to those present. …

To this end, they discussed these questions:

Where have funder policies and mandates succeeded as tools for change? What are some of the challenges?
How might we collaborate to ensure that researchers are able to engage constructively with this transition?
How might we collaborate to ensure that we are building a truly equitable global system of open research? 
How might we collaborate to ensure a sustainable approach to accelerating the transition to open research, allowing for stakeholders to thrive amidst a culture of openness? …”

NIH issues a seismic mandate: share data publicly

“In January 2023, the US National Institutes of Health (NIH) will begin requiring most of the 300,000 researchers and 2,500 institutions it funds annually to include a data-management plan in their grant applications — and to eventually make their data publicly available.

Researchers who spoke to Nature largely applaud the open-science principles underlying the policy — and the global example it sets. But some have concerns about the logistical challenges that researchers and their institutions will face in complying with it. Namely, they worry that the policy might exacerbate existing inequities in the science-funding landscape and could be a burden for early-career scientists, who do the lion’s share of data collection and are already stretched thin….

Such a seismic shift in practice has left some researchers worried about the amount of work that the mandate will require when it becomes effective….

Others worry that data-management activities will further sap funds from under-resourced labs. Although the policy outlines certain fees that researchers can add to their proposed budgets to offset the costs of compliance with the mandate, it doesn’t specify what criteria the NIH will use to grant these requests….

Despite its potential pitfalls, Ross thinks that the policy will have a ripple effect that will persuade smaller funding agencies and industry to adopt similar changes. “This policy establishes what people expect from clinical research,” he says. “It’s essentially saying the culture of research needs to change.” ”

Belgium discloses penalties for failing to report clinical trial results

“In the latest move to crack down on wayward clinical trial sponsors, Belgium may now fine companies, hospitals, and universities that fail to publicly disclose study results, a sign that more European regulators are growing concerned about a lack of transparency surrounding medical data….”

Today publication of drug trial results becomes mandatory in 30 European countries

“The European Union today launches its new clinical trial registry, marking a watershed in medical research transparency.

 

 

Companies, universities and hospitals are now legally obliged to make the results of drug trials public within one year completing a trial.

All 27 European Union countries plus Norway, Iceland and Liechtenstein have integrated the regulation into their national legal frameworks, meaning that sponsors that fail to share trial results will be in violation of national law.

 

 

 

 

 

Each country has also adopted penalties for violating this transparency requirement. Penalties vary from one country to the next. …”

 

New deposit obligation as of 1 January 2022 – Open Science

“As of 1 January 2022 the KU Leuven deposit obligation has been extended: in addition to journal articles, KU Leuven authors are now also required to deposit in Lirias a full text of every book chapter and conference proceeding they publish. Uploading the full texts of other publication types is strongly encouraged. When you select the ‘public access’ license, the Open Access Support Desk will monitor the publisher’s OA policy and the Belgian OA legislation and will apply the correct accessibility. …”

Incentivising research data sharing: a scoping review

Abstract:  Background: Numerous mechanisms exist to incentivise researchers to share their data. This scoping review aims to identify and summarise evidence of the efficacy of different interventions to promote open data practices and provide an overview of current research.

Methods: This scoping review is based on data identified from Web of Science and LISTA, limited from 2016 to 2021. A total of 1128 papers were screened, with 38 items being included. Items were selected if they focused on designing or evaluating an intervention or presenting an initiative to incentivise sharing. Items comprised a mixture of research papers, opinion pieces and descriptive articles.

Results: Seven major themes in the literature were identified: publisher/journal data sharing policies, metrics, software solutions, research data sharing agreements in general, open science ‘badges’, funder mandates, and initiatives.

Conclusions: A number of key messages for data sharing include: the need to build on existing cultures and practices, meeting people where they are and tailoring interventions to support them; the importance of publicising and explaining the policy/service widely; the need to have disciplinary data champions to model good practice and drive cultural change; the requirement to resource interventions properly; and the imperative to provide robust technical infrastructure and protocols, such as labelling of data sets, use of DOIs, data standards and use of data repositories.