“The COVID-19 pandemic prompted many groups to rethink how to perform and communicate science. Although their work has been freely available from the beginning, Boby et al. now formally report the results of the COVID Moonshot project, a fully open-science drug discovery campaign to identify, synthesize, and test inhibitors against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease, a key antiviral target (see the Perspective by Shoichet and Craik). Starting with data from a fragment-based screen, candidate inhibitor designs were crowdsourced from volunteer submitters using a variety of design approaches. An experienced team, aided by computational tools, evaluated proposals and designed synthetic routes. Noncovalent, nonpeptidomimetic inhibitors were identified and characterized functionally and structurally. Iterative medicinal chemistry and community input yielded a lead with promising bioavailability, safety, and antiviral activity. —Michael A. Funk”
“Hopkins et al1 should be commended for providing important statistics on sharing of individual-participant data (IPD) from clinical trials by pharmaceutical sponsors, using databases designed specifically for this purpose (clinicalstudydatarequest.com,2 Vivli,3 and Yale University Open Data Access4), as well as direct requests to companies that do not use such databases….
They were granted access to the data requested for 70 of them (77%). This is undoubtedly quite an achievement compared with the situation only a decade ago, when clinical trial data were considered legal property of the sponsoring companies, and as such could not be shared with anyone beyond regulatory agencies.
However, as the authors of this study1 acknowledge, the 70 trials they obtained data from represented only a small fraction of all trials conducted in the same time period. Focusing on the small subset of 203 trials mentioned in the product labels of the approved anticancer medicines, only 91 were considered eligible for data sharing. One wonders what makes a trial ineligible for data sharing, a situation that concerns more than half of the trials….”
“Today’s announcements from the Biden Cancer Moonshot include: …A new “biomedical data fabric toolbox” to advance cancer research progress. ARPA-H is partnering with the National Institutes of Health, the National Cancer Institute (NCI), and other agencies to develop a new Biomedical Data Fabric Toolbox for Cancer. Starting with cancer datasets, this program represents the first step toward transforming data accessibility across all medical domains…”
“The concept of public, barrier-free access to research findings emerged at the turn of the century. At that time, the academic publishing landscape was dominated by subscription-based journals. Initially championed by researchers, the quest for public access (often referred to as ‘open access’) gained momentum over the past decade, buoyed by public access mandates from research funders and by the dawn of transformative agreements. Yet barriers to public access to research persist, among them maintaining the financial sustainability of current publishing models. A recent webinar from the Friends of the National Library of Medicine, which was titled Public access to health information: providing trusted information to all, brought together leading multidisciplinary experts in public access to discuss these challenges and the practicalities of ensuring public access for all….”
Abstract: To ensure the widest possible dissemination of research results to the academic community, pharmaceutical industry, patients and to the broader public, the EU-funded drug repurposing project REPO4EU is committed to an Open Science approach. Because Open Science can be interpreted widely, this document lays out the strategy of the project with regard to Open Access publishing, alternative metrics, intellectual property and FAIR data, in line with the goals of the European Commission. The Open Science Strategy forms the theoretical framework for the REPO4EU Open Science publishing portal that will develop into an open hub of research results and communication for the entire drug repurposing community.
“On June 20th, Universities Allied for Essential Medicines Netherlands (UAEM NL) called upon the General Secretary of the Central Committee on Research Involving Human Subjects (CCMO) to address concerns regarding clinical trial transparency within the country.
This initiative garnered support from various allied organizations, including Health Action International, Doctors Without Borders the Netherlands, Wemos, and TranspariMED.
The CCMO is currently undergoing the reform of the Dutch National Trial Registry. As health advocacy organizations, we are eager to contribute to this pivotal effort aimed at enhancing the prompt registration and reporting of results for all clinical trials conducted in the Netherlands and eagerly anticipate engaging in productive discussions with the CCMO….”
Abstract: Large-scale clinical trials are essential in cardiology and require rapid, accurate publication, and dissemination. Whereas conference presentations, press releases, and social media disseminate information quickly and often receive considerable coverage by mainstream and healthcare media, they lack detail, may emphasize selected data, and can be open to misinterpretation. Preprint servers speed access to research manuscripts while awaiting acceptance for publication by a journal, but these articles are not formally peer-reviewed and sometimes overstate the findings. Publication of trial results in a major journal is very demanding but the use of existing checklists can help accelerate the process. In case of rejection, procedures such as easing formatting requirements and possibly carrying over peer-review to other journals could speed resubmission. Secondary publications can help maximize benefits from clinical trials; publications of secondary endpoints and subgroup analyses further define treatment effects and the patient populations most likely to benefit. These rely on data access, and although data sharing is becoming more common, many challenges remain. Beyond publication in medical journals, there is a need for wider knowledge dissemination to maximize impact on clinical practice. This might be facilitated through plain language summary publications. Social media, websites, mainstream news outlets, and other publications, although not peer-reviewed, are important sources of medical information for both the public and for clinicians. This underscores the importance of ensuring that the information is understandable, accessible, balanced, and trustworthy. This report is based on discussions held on December 2021, at the 18th Global Cardiovascular Clinical Trialists meeting, involving a panel of editors of some of the top medical journals, as well as members of the lay press, industry, and clinical trialists.
“The NIHR has been recognised as the world’s most transparent research funding body.
New analysis produced by TranspariMED shows the NIHR is the only research funder in the world to have adopted all 11 of the World Health Organisation’s recommendations for maximising clinical trial transparency and minimising waste.
making all clinical trial results public within 12 months
having specific policies to prevent waste in research and speed up the development of new treatments
requiring researchers to make key data available on public trial registries and publish their results in scientific journals
monitoring whether researchers are following best practices, and sanctioning those that do not…”
“Open Pharma has developed a new, free-to-view, online tool that reports open access (OA) publishing rates, access types and OA licences for peer-reviewed medical publications with authors affiliated to pharma companies and universities.
The Open Pharma OA position statement emphasizes the importance of publishing research OA to ensure that high-quality, peer-reviewed evidence is available to anyone who needs it, anywhere in the world and without charge.
The recognized benefits of OA publishing include improved equity in access to medical knowledge and scientific advances, increased research transparency and the potential to foster greater public trust in scientific research (Figure 1). Emerging data from global publishers Taylor & Francis also suggest that research published OA typically has higher reach and impact than comparable paywalled articles of a similar age….”
“This week, we are excited to announce that our open access dashboard has gone live! We also highlight our poster about the dashboard that we presented at the 19th Annual Meeting of ISMPP earlier this week. We read about potential social biases in authors’ willingness to share data, about community engagement in relation to data sharing, and about an editor exodus from two leading neuroscience journals. Finally, we highlight the upcoming ISPOR 2023 conference, as well as a virtual session on open science hosted by the UN….”
Abstract: Objective Prospective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications and investigated factors associated with transparent reporting.
Design We used a dataset of trials registered in ClinicalTrials.gov or Deutsches Register Klinischer Studien, with a German University Medical Center as the lead centre, completed in 2009–2017, and with a corresponding peer-reviewed results publication. We extracted all registration statements from results publications of retrospectively registered trials and assessed whether they mention or justify the retrospective registration. We analysed associations of retrospective registration and reporting thereof with registration number reporting, International Committee of Medical Journal Editors (ICMJE) membership/-following and industry sponsorship using ?2 or Fisher exact test.
Results In the dataset of 1927 trials with a corresponding results publication, 956 (53.7%) were retrospectively registered. Of those, 2.2% (21) explicitly report the retrospective registration in the abstract and 3.5% (33) in the full text. In 2.1% (20) of publications, authors provide an explanation for the retrospective registration in the full text. Registration numbers were significantly underreported in abstracts of retrospectively registered trials compared with prospectively registered trials. Publications in ICMJE member journals did not have statistically significantly higher rates of both prospective registration and disclosure of retrospective registration, and publications in journals claiming to follow ICMJE recommendations showed statistically significantly lower rates compared with non-ICMJE-following journals. Industry sponsorship of trials was significantly associated with higher rates of prospective registration, but not with transparent registration reporting.
Conclusions Contrary to ICMJE guidance, retrospective registration is disclosed and explained only in a small number of retrospectively registered studies. Disclosure of the retrospective nature of the registration would require a brief statement in the manuscript and could be easily implemented by journals.
“ClinicalTrials.gov is the world’s largest database of privately and publicly funded clinical trials. It provides easy access to clinical trial information for millions of users every month—from patients and their advocates to data submitters, data researchers, and the broader public. NLM is in the midst of a multi-year effort to modernize ClinicalTrials.gov to deliver an improved user experience on an updated platform that will accommodate future growth and enhance efficiency.
In June 2023, we will reach an important milestone: replacing the current website with the modernized ClinicalTrials.gov website. This modernized site will implement the innovations we have designed based on user feedback, including an updated look and feel and improved functionality for searching, viewing, and downloading information about clinical trials….”
“This webinar introduces the Europe PMC human-annotated full-text corpus for Gene/Proteins, Diseases and Organisms and highlights how it has been used to train machine learning models for systematic identification and prioritisation of potential therapeutic drugs by the Open Targets Platform. This webinar will explain how to access and reuse the annotated corpus as an open community resource and provide an overview of the Open Targets Platform.
Europe PMC is an open access life science database of journal articles and preprints, containing over 41 million abstracts and 8.7 million full-text articles. Open Targets Platform is an innovative public-private partnership that uses human genetics and genomics data for systematic drug target identification and prioritisation….”
“Some time ago, Archivos de Bronconeumología reported on a radical turnabout by the ICMJE: after announcing in 2016 that they would require clinical trial researchers to share individual-level anonymized participant data with third parties, in 2017 they decided that such transfer would be voluntary.4 The news had a precedent in the Recommendations published a few years earlier, to the effect that some journal editors “ask authors to say whether the study data are available to third parties to view and/or use/reanalyze, while still others encourage or require authors to share their data with others for review or reanalysis”.1 It would be interesting to know which Spanish journals have included this requirement in their ‘instructions for authors’ and whether they comply with it.
To answer this question, we reviewed the portals of 24 Spanish journals with an impact factor greater than 1, on the understanding that they have greater influence than those with an impact factor ?1 and those with no impact factor. Of these 24, 14 are included in the list of ICMJE Recommendations (Supplementary material A). Of these, only 5 (Archivos of Bronconeumología, Atención Primaria, Enfermedades Infecciosas y Microbiología Clínica, Gaceta Sanitaria, and Medicina Intensiva) include a specific section, that we shall call “link to data repository”, that recommends, supports and encourages authors to share raw data from their studies with other researchers, and gives instructions on how to go about it. A sixth journal, the Revista de Neurología, recommends this procedure only for clinical trials (Supplementary material B). To determine the frequency with which authors report how data can be accessed compared to other requirements requested by the same journals, 2 control requirements were selected: reporting on conflicts of interest and study funding, that were included in the Recommendations much earlier. It is also of interest to determine whether supplementary material may be included online, as this is sometimes a way of including raw study data….
Sharing data from quantitative studies is much easier than from qualitative studies. Researchers performing qualitative studies frequently cite the lack of authorization of the participants, the sensitive nature of the data, and loss of confidentiality as reasons for not sharing data.6 However, qualitative studies are the exception among Spanish medical publications. By 2011, most researchers were already sharing their data, although this was challenging for more than a third of them; in the case of clinical trials, it has recently been reported that access7 to data is difficult despite authors’ commitment to share.8 Ideally, Spanish medical journals should require authors to share them in all the articles they publish, and if data sharing is impossible, to explain why.”
Abstract: Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing:
Rule 1: Abide by local legal and regulatory data protection requirements
Rule 2: Anticipate the possibility of clinical trial data-sharing before obtaining funding
Rule 3: Declare your intent to share data in the registration step
Rule 4: Involve research participants
Rule 5: Determine the method of data access
Rule 6: Remember there are several other elements to share
Rule 7: Do not proceed alone
Rule 8: Deploy optimal data management to ensure that the data shared is useful
Rule 9: Minimize risks
Rule 10: Strive for excellence.