Featuring changes to clinical trial reporting and data sharing regulations, and criticism of Plan S from the perspective of highly selective subscription journals
Further steps to ensure clinical trial reporting via TranspariMED
Failure to disclose clinical trial results poses a risk to both patient welfare and the integrity and reputation of public health services. A government enquiry last year revealed that UK universities had failed to disclose the results of 254 clinical trials to the EU Clinical Trials Register, and that a further 170 trials had been left unreported by the National Health Service (NHS). In the wake of the report published by TranspariMED and Universities Allied for Essential Medicines earlier this year, the UK government has announced plans to implement a national clinical trial transparency strategy. Since the report was made public, efforts have been made to improve trial reporting with some universities and NHS trusts now reporting close to 100% of clinical trial results. Despite these improvements, Norman Lamb MP, Chair of Parliament’s Science and Technology Committee, has called for the government to commit funding to the transparency-monitoring scheme.
Is 2019 the year for clinical trial data sharing? via STAT News
Regardless of the issues with sharing clinical trial data, a large number of the world’s leading medical journals, including The Lancet and The BMJ, now require authors not only to declare if and how they intend to share their deidentified patient data but also to disclose these plans in a public registry such as ClinicalTrials.gov. Although these journals do not mandate authors to share clinical trial data, the new requirement to disclose a study’s intention to share data is helping encourage researchers to consider data sharing even before patient registration. Data sharing between clinical trials maximizes the impact that a patient’s data can have. From the researcher’s perspective, this leads to more citations, which can contribute to career progression. As the practice of making clinical trial data available to other investigators becomes more commonplace, several platforms have been developed to address researchers’ concerns and facilitate the practical aspects of data sharing.
Following the consultation on Plan S, many large subscription publishers have rallied to contest the plan stating they cannot comply with the initiative unless the rules are changed. The publishers, including Nature and Science, have attributed their appeals to high internal publishing costs (€10 000–30 000 per article at Springer Nature). Such journals reject more articles than they accept. Therefore, article processing charges (APCs) that funders and researchers would find acceptable would not even come close to covering the costs of these publishers’ internal editorial processes and cutting costs then runs the risk of compromising the quality of publications.
As a middle ground, these publishers have called for a different approach to comply with Plan S; this involves a transitional phase towards immediate open access achieved through either funding for these publishers to convert to the hybrid publishing model or by creating mirror journals. An alternative suggestion is to allow journals to charge both a submission fee and an APC. Journals would share a near-final version of the article after a 6-month embargo period, with the final version still accessible only through a freely accessible read-only link or through journal subscription. As things stand at the moment, neither of these proposals comply with Plan S. Although the International Association of STM Publishers has said that there is no one-size-fits-all model for this transition, Plan S architect Robert-Jan Smits has suggested that these publishers need to develop a new business model in order to comply with Plan S and maintain publication quality. It will be interesting to see how Head of Open Research at the Wellcome Trust Robert Kiley, acting as cOAlition S’s coordinator following Robert-Jan Smits departure, reacts to these appeals.