Social media attention and citations of published outputs from re-use of clinical trial data: a matched comparison with articles published in the same journals | BMC Medical Research Methodology | Full Text

Abstract:  Background

Data-sharing policies in randomized clinical trials (RCTs) should have an evaluation component. The main objective of this case–control study was to assess the impact of published re-uses of RCT data in terms of media attention (Altmetric) and citation rates.

Methods

Re-uses of RCT data published up to December 2019 (cases) were searched for by two reviewers on 3 repositories (CSDR, YODA project, and Vivli) and matched to control papers published in the same journal. The Altmetric Attention Score (primary outcome), components of this score (e.g. mention of policy sources, media attention) and the total number of citations were compared between these two groups.

Results

89 re-uses were identified: 48 (53.9%) secondary analyses, 34 (38.2%) meta-analyses, 4 (4.5%) methodological analyses and 3 (3.4%) re-analyses. The median (interquartile range) Altmetric Attention Scores were 5.9 (1.3—22.2) for re-use and 2.8 (0.3—12.3) for controls (p?=?0.14). No statistical difference was found on any of the components of in the Altmetric Attention Score. The median (interquartile range) numbers of citations were 3 (1—8) for reuses and 4 (1 – 11.5) for controls (p?=?0.30). Only 6/89 re-uses (6.7%) were cited in a policy source.

Conclusions

Using all available re-uses of RCT data to date from major data repositories, we were not able to demonstrate that re-uses attracted more attention than a matched sample of studies published in the same journals. Small average differences are still possible, as the sample size was limited. However matching choices have some limitations so results should be interpreted very cautiously. Also, citations by policy sources for re-uses were rare.

Delays in reporting and publishing trial results during pandemics: cross sectional analysis of 2009 H1N1, 2014 Ebola, and 2016 Zika clinical trials | BMC Medical Research Methodology | Full Text

Abstract:  Background

Pandemic events often trigger a surge of clinical trial activity aimed at rapidly evaluating therapeutic or preventative interventions. Ensuring rapid public access to the complete and unbiased trial record is particularly critical for pandemic research given the urgent associated public health needs. The World Health Organization (WHO) established standards requiring posting of results to a registry within 12 months of trial completion and publication in a peer reviewed journal within 24 months of completion, though compliance with these requirements among pandemic trials is unknown.

Methods

This cross-sectional analysis characterizes availability of results in trial registries and publications among registered trials performed during the 2009 H1N1 influenza, 2014 Ebola, and 2016 Zika pandemics. We searched trial registries to identify clinical trials testing interventions related to these pandemics, and determined the time elapsed between trial completion and availability of results in the registry. We also performed a comprehensive search of MEDLINE via PubMed, Google Scholar, and EMBASE to identify corresponding peer reviewed publications. The primary outcome was the compliance with either of the WHO’s established standards for sharing clinical trial results. Secondary outcomes included compliance with both standards, and assessing the time elapsed between trial completion and public availability of results.

Results

Three hundred thirty-three trials met eligibility criteria, including 261 H1N1 influenza trials, 60 Ebola trials, and 12 Zika trials. Of these, 139 (42%) either had results available in the trial registry within 12 months of study completion or had results available in a peer-reviewed publication within 24 months. Five trials (2%) met both standards. No results were available in either a registry or publication for 59 trials (18%). Among trials with registered results, a median of 42 months (IQR 16–76 months) elapsed between trial completion and results posting. For published trials, the median elapsed time between completion and publication was 21 months (IQR 9–34 months). Results were available within 24 months of study completion in either the trial registry or a peer reviewed publication for 166 trials (50%).

Conclusions

Very few trials performed during prior pandemic events met established standards for the timely public dissemination of trial results.

JAMA Publishes Trial Results Delayed 5 Years. Here’s Why

“A treatment for shortening the painful episodes of sickle cell disease (SCD) is not effective, results published in JAMA indicate. But the effort it took to publish the findings is an important part of the story and reveal problems with data ownership, company motivations, and public resources that go well beyond a single clinical trial or experimental agent….”

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

“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.”

 

 

What is RIAT? – RIAT Support Center

“RIAT is an international effort to tackle bias in the way research is reported with the goal of providing more accurate information to patients and other healthcare decision makers.

Randomized controlled trials are known as medicine’s “gold standard” for reliable evidence. However, they are falling short of that standard, in large part due to two fundamental problems:

MISREPORTING: many trials that are published are inaccurately or incompletely reported (misreported trials)
INVISIBILITY: not all trials conducted are published (unpublished trials)

When the original investigators or sponsors do not correct misreporting, or even leave the entire trial unpublished, they can be considered to have abandoned their trial. And the downstream effects can be substantial, drawing to false conclusions about the effectiveness and safety of medical interventions.

The RIAT initiative aims to address these problems by offering a methodology that allows other people to responsibly correct the record….”

Line-by-line data of clinical trial audit – a Freedom of Information request to Health Research Authority – WhatDoTheyKnow

“This FOI is filed on behalf of TranspariMED.

The FOI relates to the HRA’s “Clinical Trial Registration Audit Report” covering trials receiving ethics approval during H1 2018:
https://www.hra.nhs.uk/planning-and-impr…

Please provide the following information:

1. A copy of the full data set that formed the basis for the report of September 2015, including all lines and columns included in the original data set. Please provide the data in Excel format. In case you do not provide the full data set, please redact (rather than delete) the data fields not released, leaving intact the corresponding line and/or column headings.

2. An estimate of the total HRA staff workload involved in performing this audit, using FTE person-days as the metric.

Please note that in response to a similar previous request, the HRA found that it is in the public interest to release this information:
https://www.whatdotheyknow.com/request/d…

Please also note that in its previous response (linked above), the HRA provided a data set that was barely usable. Please provide a data set that is comprehensible and fully usable in order to avoid the need to manage a request for internal review….”

Actives from MMV Open Access Boxes? A suggested way forward

Abstract:  It is estimated that more than 1 billion people across the world are affected by a neglected tropical disease (NTD) that requires medical intervention. These diseases tend to afflict people in areas with high rates of poverty and cost economies billions of dollars every year. Collaborative drug discovery efforts are required to reduce the burden of these diseases in endemic regions. The release of “Open Access Boxes” is an initiative launched by Medicines for Malaria Venture (MMV) in collaboration with its partners to catalyze new drug discovery in neglected diseases. These boxes are mainly requested by biology researchers across the globe who may not otherwise have access to compounds to screen nor knowledge of the workflow that needs to be followed after identification of actives from their screening campaigns. Here, we present guidelines on how to move such actives beyond the hit identification stage, to help in capacity strengthening and enable a greater impact of the initiative.

 

 

Promoting versatile vaccine development for emerging pandemics | npj Vaccines

“In this case, the generated knowledge is a clear example of a positive spillover that creates a need for public intervention into the market for research and development. However, this relies on the results of translatable work on prototype pathogens—such as insights into antigen optimisation—being accessible to public use. Therefore, public funding of prototype pathogen work should seek to promote research that generates openly accessible and translatable insights as far as practicable, while also judiciously taking advantage of generating proprietary intellectual property. Even in the cases where a proprietary insight might primarily benefit the originating organisation, such as early preclinical evidence and safety data from clinical trials, the research remains worthy of subsidy because society benefits from having developers that are better prepared to respond to emerging infectious diseases….”

Bill Gates, Vaccine Monster | The New Republic

“Battle-scarred veterans of the medicines-access and open-science movements hoped the immensity of the pandemic would override a global drug system based on proprietary science and market monopolies. By March, strange but welcome melodies could be heard from unexpected quarters. Anxious governments spoke of shared interests and global public goods; drug companies pledged “precompetitive” and “no-profit” approaches to development and pricing. The early days featured tantalizing glimpses of an open-science, cooperative pandemic response. In January and February 2020, a consortium led by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases collaborated to produce atomic-level maps of the key viral proteins in record time. “Work that would normally have taken months—or possibly even years—has been completed in weeks,” noted the editors of Nature. …

By then, however, the optimism and sense of possibility that defined the early days were long gone. Advocates for pooling and open science, who seemed ascendant and even unstoppable that winter, confronted the possibility they’d been outmatched and outmaneuvered by the most powerful man in global public health.

In April, Bill Gates launched a bold bid to manage the world’s scientific response to the pandemic. Gates’s Covid-19 ACT-Accelerator expressed a status quo vision for organizing the research, development, manufacture, and distribution of treatments and vaccines. Like other Gates-funded institutions in the public health arena, the Accelerator was a public-private partnership based on charity and industry enticements. Crucially, and in contrast to the C-TAP, the Accelerator enshrined Gates’s long-standing commitment to respecting exclusive intellectual property claims. Its implicit arguments—that intellectual property rights won’t present problems for meeting global demand or ensuring equitable access, and that they must be protected, even during a pandemic—carried the enormous weight of Gates’s reputation as a wise, beneficent, and prophetic leader. …

“Early on, there was space for Gates to have a major impact in favor of open models,” says Manuel Martin, a policy adviser to the Médecins Sans Frontières Access Campaign. “But senior people in the Gates organization very clearly sent out the message: Pooling was unnecessary and counterproductive. They dampened early enthusiasm by saying that I.P. is not an access barrier in vaccines. That’s just demonstratively false.”…

“Things could have gone either way,” says Love, “but Gates wanted exclusive rights maintained. He acted fast to stop the push for sharing the knowledge needed to make the products—the know-how, the data, the cell lines, the tech transfer, the transparency that is critically important in a dozen ways. The pooling approach represented by C-TAP included all of that. Instead of backing those early discussions, he raced ahead and signaled support for business-as-usual on intellectual property by announcing the ACT-Accelerator in March.” …”