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. …”



‘The EMA is withholding too much information”, 1 May 2022

“Transparency is a requirement for better and safer patient care. There is no valid reason to hide information about clinical trials, their methodology or their results, or evaluation data obtained on drugs after their market introduction, particularly data on adverse effects.

The creation of the European Medicines Agency (EMA) in 1995 constituted a step forward, compared with the practices of France’s drug regulatory agency at the time. For example, the EMA’s online publication of information on drug evaluations, such as European Public Assessment Reports, was a major advance in transparency as to the data in its possession….

It is one thing for pharmaceutical companies to consider that data showing the limitations of their drugs are commercially sensitive. But it is quite another – and utterly unacceptable – for the EMA to actually orchestrate the concealment of these data by pharmaceutical companies.

Transparency is not a fad or an end in itself. In the pharmaceutical field, it is a requirement for better and safer patient care. There is no valid reason to hide information about clinical trials, their methodology or their results, or evaluation data obtained on drugs after their market introduction, particularly data on adverse effects.


Perhaps there are certain individuals within the EMA who are dissatisfied with this situation? Or who are simply resigned to the power relations at play? Or who feel that the way the EMA operates is a necessary compromise, given the varying legislation? If so, these individuals are not speaking up and their opinions are not reflected in the EMA’s practices. Whatever the case may be, Prescrire’s negative assessment of the level of transparency at the EMA is intended as a wake-up call for policy makers and for legal bodies (such as the Ombudsman) who are in a position to improve the EMA’s operational practices….”


RE: Copyright Concerns With Public Access Language in U.S. Innovation and Competition Act – Section 2527(b)

“We write to express our serious concerns about Section 2527(b) of the United States Innovation and Competition Act of 2021 (“USICA,” S. 1260). Instead of supporting American innovation and competitiveness, this provision—which addresses public access requirements for certain copyrighted works that discuss federally funded research—would undermine copyright protection and weaken American intellectual property exports, ultimately impeding the commercialization of research and stifling American competitiveness. We understand that this language remained in the Senate-passed USICA last year largely because of procedural challenges with amending the bill following its introduction. We were grateful that this language was not included in the House’s America COMPETES Act 2022 (“COMPETES,” H.R. 4521), and we urge you to ensure that Section 2527(b) of USICA is not included in the final legislation following a conference on these two bills….”

Discrepancies between FDA documents and ClinicalTrials.gov for Orphan Drug-related clinical trial data

Abstract:  Clinical trial registries such as ClinicalTrials.gov (CTG) hold large amounts of data regarding trials. Drugs for rare diseases are known as orphan drugs (ODs), and it is particularly important that trials for ODs are registered, and the data in the trial record are accurate. However, there may be discrepancies between trial-related data that were the basis for the approval of a drug, as available from Food and Drug Administration (FDA) documents such as the Medical Review, and the data in CTG. We performed an audit of FDA-approved ODs, comparing trial-related data on phase, enrollment, and enrollment attribute (anticipated or actual) in such FDA documents and in CTG. The Medical Reviews of 63 ODs listed 422 trials. We used study identifiers in the Medical Reviews to find matches with the trial ID number, ‘Other ID’ or ‘Acronyms’ in CTG, and identified 202 trials that were registered with CTG. In comparing the phase data from the ‘Table of Clinical Studies’ of the Medical Review, with the data in CTG, there were exact matches in only 75% of the cases. The enrollment matched only in 70% of the cases, and the enrollment attribute in 91% of the cases. A similar trend was found for the sub-set of pivotal trials. Going forward, for all trials listed in a registry, it is important to provide the trial ID in the Medical Review. This will ensure that all trials that are the basis of a drug approval can be swiftly and unambiguously identified in CTG. Also, there continue to be discrepancies in trial data between FDA documents and CTG. Data in the trial records in CTG need to be updated when relevant.



No records found for 220 clinical trials of orphan drugs approved by the FDA

“A new study has found widespread gaps and inconsistencies in clinical trials of orphan drugs, suggesting suboptimal data management by the FDA and failures by some pharma companies to consistently register clinical trials and keep public registry records up to date.



The study team compared publicly available FDA documents and ClinicalTrials.gov registry data for 63 orphan drugs approved between 2009-2019.



FDA documents identified 422 clinical trials linked to these drug approvals, but the team was only able to find 202 related trials in the ClinicalTrials.gov registry. 220 trials could not be located on the registry.\



For those trials with data available in both types of sources, the number of trial participants recruited did not match in over 30% of cases….”

Maryland Gives Up on Its Library E-book Law

“Maryland’s library e-book law is effectively dead. In a court filing this week, Maryland Attorney General Brian E. Frosh said the state would present no new evidence in a legal challenge filed by the Association of American Publishers, allowing the court’s recently issued preliminary injunction blocking the law to stand, and paving the way for it to be converted into a permanent injunction. …

First introduced in January 2021, the Maryland law required any publisher offering to license “an electronic literary product” to consumers in the state to also offer to license the content to public libraries “on reasonable terms” that would enable library users to have access. The bill passed the Maryland General Assembly unanimously on March 10, and went into effect on January 1, 2022.

The law emerged after a decade of tension in the digital library market, with libraries long complaining of unsustainable, non-negotiated high prices and restrictions. More specifically, however, the law emerged as a direct response to Macmillan’s (since abandoned) 2019 embargo on frontlist e-book titles, which prompted numerous appeals to both federal and state legislators to protect basic access to digital works in libraries. …”

European parliamentarians urge action on missing clinical trial results

“A cross-party group of members of the European parliament has sent an open letter to regulators urging them to not drop the ball on over 3,400 clinical trial results that are still missing on the EudraCT trial registry, in violation of long-standing transparency rules.



Under European rules, institutions running investigative drug trials must make their results public within 12 months of trial completion. While the rules are set at the European level, responsibility for encouraging and enforcing compliance lies with the national medicines regulators in each country….”

Goodbye, world! OER World Map Blog

The North-Rhine Westphalian Library Service Centre (hbz) will cease operating the OER World Map on 2022-04-29. We would like to thank all those who have supported and promoted the project in recent years. hbz will provide an appropriate solution for archiving the collected data. The software and data are openly licensed, so it is possible to continue operating the platform. If you are interested in continuing to operate the OER World Map, please do not hesitate to contact us at info@oerworldmap.org.  

Proposal for a Digital Services Act — Research, Education, and Science as Collateral Damage – LIBER Europe

“Schools and universities are highly reliant on the multiple digital platforms and infrastructures that provide services to students, teachers, and researchers. It is therefore surprising that the Digital Services Act (DSA) does not consider the impact that this new regulation will have on education and Open Science.

In fact, despite high levels of public investment in education and research, infrastructures (such as institutional and national repositories as well as platforms like Zenodo, the European Open Science Cloud, arXiv.org etc.), they do not feature at all in the European Commission’s impact assessment, nor are they mentioned in the draft Digital Services Act….”

Substantial delays in clinical data published by the European Medicines Agency – a cross sectional study – Journal of Clinical Epidemiology



Reporting bias poses a fundamental threat to the transparency and validity of interpretations of clinical trials, which may, in part, be mitigated through access Clinical Study Reports (CSRs). The European Medicines Agency (EMA), under their Policy 0070, prospectively publishes clinical data, including CSRs, submitted as part of marketing authorization applications or post-authorization procedures, although this practice is currently suspended for non-COVID-19 medicines, and have set out planned timelines for publication.



We conducted a cross-sectional study assessing the content and characteristics of all clinical data packages released by the EMA under Policy 0070 and the time to their publication. We extracted the number and characteristics of trials included in the clinical packages, assessed the delay to publication relative to the EMAs planned timeline and whether it differed between the EMAs various transparency measures and types of application procedures.



We identified 148 clinical data packages that contained data on a total of 1,005 clinical trials, of which 261 (26%) were labelled as phase 3 trials. Full CSRs were available for 913 (90•8%) of the trials. The median time to publication was 511 (IQR 411 to 574) days. Only 2 (1•4%) of the clinical data packages were published within the EMA’s planned timeline. The delay was shorter for clinical data packages released under the EMAs transparency measures for COVID.19 medicines compared with their standard transparency measure.



The clinical data packages released by the EMA under Policy 0070 contained CSRs on many trials but were published with considerable delays relative to the timeline set forth by the EMA, reducing their potential impact on reporting bias.

Where are the Clinical Study Reports we were promised?

“Years ago, the European Medicines Agency announced that it would proactively make CSRs accessible to independent researchers. It was the first regulator worldwide to do so. Medical researchers strongly applauded the move. (Health Canada has since launched a similar transparency effort.)



However, new research shows that the European Medicines Agency’s efforts have lagged far behind its own disclosure targets. …”

Mozilla adds tiered subscription plans to MDN Web Docs • The Register

“The Mozilla Developer Network, which hosts free, open access to web standard documentation, tools, samples and other good stuff, is going pay-for-play with a premium subscription plan that adds new personalization features. 

The Firefox maker announced today the subscription service, called MDN Plus, saying it will add three features for paid MDN users at launch: Notifications, collections, and MDN Offline….”