Rapid, accurate publication and dissemination of clinical trial results: benefits and challenges | European Heart Journal | Oxford Academic

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 Social media, websites, mainstream news outlets, and other publications, although not peer-reviewed, are important sources of medical information for both the public and for clinicians.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.


NIHR tops international chart for clinical trial transparency | NIHR

“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.

These include:

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 launches new open access benchmarking tool – Open Pharma – Innovations in medical publishing

“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….”

Weekly digest: Open Pharma open access dashboard, benchmarking and data sharing – Open Pharma – Innovations in medical publishing

“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….”

Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials | BMJ Open

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 Modernizing to Serve You Better – NLM Musings from the Mezzanine

“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….”

Discover drug targets with Europe PMC Machine Learning Dataset and Open Targets – YouTube

“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….”

Researchers Forget to Report How to Share Data From Studies Published in Spanish Medical Journals – ScienceDirect

“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.”

Ten (not so) simple rules for clinical trial data-sharing | PLOS Computational Biology

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.

Taylor & Francis Becomes the Newest Supporter of Open Pharma | STM Publishing News

“Open Pharma and Taylor & Francis are delighted to announce that Taylor & Francis has become the latest official Supporter of the Open Pharma initiative…

Today‘s announcement that Taylor & Francis has become an official Supporter of Open Pharma reflects the fact that the two organizations share the same commitment to connecting pharma with innovations in publishing to increase transparency and access to research outputs.

These shared values were illustrated in 2021, when Open Pharma published their recommendations for plain language summaries of peer-reviewed medical journal publications in the Taylor & Francis journal Current Medical Research and Opinion (CMRO).* One of more than 2700 peer-reviewed journals published by Taylor & Francis, Open Pharma selected CMRO because of its complete range of open access options and its commitment to publishing innovations and research in medical and scientific publishing….:

Implementing clinical trial data sharing requires training a new generation of biomedical researchers | Nature Medicine

“Data sharing enhances the value of medical research and builds trust in clinical trials, but more biomedical researchers need to be trained in these approaches, which include meta-research, data science and ethical, legal and social issues….”

[Open letter to US FDA and NIH]

“I write regarding concerns about the lack of compliance by medical product sponsors with requirements to report certain clinical trial results information to the ClinicalTrials.gov database. The law requires that certain clinical trial sponsors report results to ClinicalTrials.gov to expand the knowledge base, support additional research, and provide important safety and efficacy information to health care providers and researchers. These important goals depend on adequate compliance with applicable requirements and appropriate enforcement.”

US congress committee calls for tougher action on trial sponsors who fail to meet reporting deadlines | The BMJ

“A US congress committee has criticised the Food and Drug Administration (FDA) and National Institutes of Health (NIH) for taking “only modest compliance action” against clinical trial sponsors who have not published results.1

Under US law, clinical trial sponsors are required to submit their results within one year of the completion date. Research looking at compliance in recent years found, however, that over 5000 trials were in “violation of applicable reporting requirements,”2 while over half (37 of 72) of reviewed trials that were funded by the NIH had failed to comply with applicable reporting requirements.3

The US Congressional Committee on Energy and Commerce has written to ask why the FDA and NIH have failed to sanction trial sponsors who break reporting rules….”

Patients at the Heart of the Scientific Dialogue: An Industry Perspective | SpringerLink

“Pharmaceutical companies need to regularly communicate to patients all essential information about their medicines, especially data from the research studies that were conducted to evaluate the medicine’s benefits and risks. To do that, companies will need to make sure patients have access to and awareness of relevant information. This can be achieved by ensuring medical information is freely available to the reader, and working with publishers to facilitate open access (free) publications. Companies should also help improve patients’ understanding of medical terminology, offer simplified versions of scientific content, and deliver information through various formats (print versus digital, text versus audio versus video) to address different learning styles and literacy levels. This will empower patients with knowledge and improve shared decision-making. It will also be essential for pharmaceutical companies to involve patients in various stages of medicine development, such as getting their input on how the research studies for investigating these medicines are designed and reported to ensure relevant information to patients are well-captured and clear. This should also go in parallel with providing opportunities to elevate the patient voice through patient-partnered research and authorship on topics particularly relevant to them.”


Open and reusable annotated mass spectrometry dataset of a chemodiverse collection of 1,600 plant extracts | GigaScience | Oxford Academic

Abstract:  As privileged structures, natural products often display potent biological activities. However, the discovery of novel bioactive scaffolds is often hampered by the chemical complexity of the biological matrices they are found in. Large natural extract collections are thus extremely valuable for their chemical novelty potential but also complicated to exploit in the frame of drug-discovery projects. In the end, it is the pure chemical substances that are desired for structural determination purposes and bioactivity evaluation. Researchers interested in the exploration of large and chemodiverse extract collections should thus establish strategies aiming to efficiently tackle such chemical complexity and access these structures. Establishing carefully crafted digital layers documenting the spectral and chemical complexity as well as bioactivity results of natural extracts collections can help prioritize time-consuming but mandatory isolation efforts. In this note, we report the results of our initial exploration of a collection of 1,600 plant extracts in the frame of a drug-discovery effort. After describing the taxonomic coverage of this collection, we present the results of its liquid chromatography high-resolution mass spectrometric profiling and the exploitation of these profiles using computational solutions. The resulting annotated mass spectral dataset and associated chemical and taxonomic metadata are made available to the community, and data reuse cases are proposed. We are currently continuing our exploration of this plant extract collection for drug-discovery purposes (notably looking for novel antitrypanosomatids, anti-infective and prometabolic compounds) and ecometabolomics insights. We believe that such a dataset can be exploited and reused by researchers interested in computational natural products exploration.