Featuring a summary of a recent study on the compliance of clinical trial reporting under US law, the role of patients in medical publishing, the rising popularity of preprints and an overview of Open Pharma’s activities this week.
How compliant are sponsors in reporting clinical trial results? via The Lancet
The final rule of the Food and Drug Administration Amendments Act of 2007 states that clinical trial data must be reported on ClinicalTrials.gov within 1 year of trial completion. Ben Goldacre, together with Nicholas J DeVito and Seb Bacon of the Evidence-Based Medicine DataLab, at the University of Oxford, investigated the compliance of sponsors in reporting clinical trial data. Their report, which was published at the end of last week, shows that between March 2018 and September 2019, results from only 40.9% of trials were reported within the 1-year deadline. Industry sponsors and large (experienced) sponsors were most likely to report trial data, whereas universities were the least likely. The sponsor with the lowest compliance was the US government, and in the words of DeVito et al., “The fact that the US government cannot comply with its own laws is especially concerning.” This study endorses the idea of imposing fines and sanctions on sponsors who breach ethical and legal obligations to report trials appropriately. In the meanwhile, Ben has developed a tool, the TrialsTracker for both the USA and the EU, in order to comprehensively follow the progress and compliance of sponsors in reporting clinical trial data.
The future of patient involvement in medical publishing via The Publication Plan
In a recent interview, Dawn Lobban, Senior Scientific Lead at Alligent Europe, Envision Pharma Group, highlighted the value of patient engagement both in the drug development lifecycle and the publishing process. Patient engagement may be a powerful way to improve study designs and also enhance transparency and support open science initiatives, with Dawn suggesting that patients ‘’are likely to be strong advocates for open access journals offering timely review and innovative ways to extend the reach of published research.” In accordance with the authorship criteria of the International Committee of Medical Journal Editors, patients would need to be involved in all stages of publication development – from the initial conception and design of a study to the final dissemination of information. Hence, Dawn Lobban advocates the further development of suitable guidelines and protocols for such patient involvement. Currently, the Association of the British Pharmaceutical Industry provides guidelines for working with patients, and Dawn expects that the latest version of the Good Publication Practice 4 guidelines will include further guidance on patient engagement in medical publishing. Such initiatives are a positive step towards reinforcing public trust in science, are driving support for open access and, above all, will lead to improved health outcomes for patients.
The future of preprints in strengthening open science via Medium
The medical publishing process is notoriously slow, and published articles are often hidden behind paywalls, making them difficult to access and thus frequently deterring scientific learning and progress. Preprints, which are online versions of manuscripts posted by authors before they have been peer reviewed, offer an innovative way to efficiently and openly disseminate scientific knowledge among many scientific communities. At the recent Preprints Input/Output workshop – co-hosted by Jessica Polka, Executive Director of Accelerating Science and Publication in biology – several preprint service providers, biomedical researchers, open science advocates, tool developers and scholarly publishers met to discuss novel ways of innovating and promoting preprints. Key ideas included the creation of automated processes and frameworks to assist authors, advocating for language translational tools and incentivizing authors to opt into posting preprints. Such workshops are vital for increasing the use of preprints and the future support for open science.
A busy week for Open Pharma! (by Sarah Sabir)
This week, Members and Supporters of Open Pharma came together for the Annual General Meeting (AGM) and a roundtable kindly hosted by GSK, at GSK House in Brentford.
Discussion at the AGM covered a review of Open Pharma’s achievements in 2019 and potential objectives for 2020. During the roundtable, attendees reflected on the communication and impact of the Open Pharma position statement on open access since its launch in October 2019, and shared an update on the endorsements received to date – the total now stands at 100 from across the globe! The group addressed how we could increase open access within pharma and the barriers that the industry currently faces.
In the second session of the roundtable, participants discussed ways of communicating publications effectively through patient lay summaries and enhanced media, such as video bytes and graphical abstracts. They agreed that it is important to increase the impact of publications through enhanced content and that not doing so could mean that readers would be more likely to read material that may not be factually correct. The main challenge discussed was how to make enhanced content discoverable by everyone, including patients, busy healthcare providers and caregivers. The final session included presentations on the visibility of publications through preprints, self-archiving repositories and existing platforms. Discussions on these topics continued throughout the week, with many of the attendees venturing into the 2020 European Meeting of the International Society for Medical Publication Professionals (ISMPP) .
Detailed blog posts on the Open Pharma roundtable and the 2020 European Meeting of ISMPP will be posted here soon!