Publication bias; Reporting; Randomised clinical trials; Clinical trial registers; Quality
Speich Benjamin, Chammartin Frédérique, Smith Daniel, Stoeckle Marcel P., Amico Patrizia, Eichenberger Anna L., Hasse Barbara, Schuurmans Macé M., Müller Thomas, Tamm Michael, Dickenmann Michael, Abela Irene A., Trkola Alexandra, Hirsch Hans H., Manuel Oriol, Cavassini Matthias, Hemkens Lars G., Briel Matthias, Mueller Nicolas J., Rauch Andri, Günthard Huldrych F., Koller Michael T., Bucher Heiner C., Kusejko Katharina (2021), A trial platform to assess approved SARS-CoV-2 vaccines in immunocompromised patients: first sub-protocol for a pilot trial comparing the mRNA vaccines Comirnaty® and COVID-19 mRNA Vaccine Moderna®, in Trials
, 22(1), 724-724.
Speich Benjamin, Gloy Viktoria L., Klatte Katharina, Gryaznov Dmitry, Taji Heravi Ala, Ghosh Nilabh, Marian Ioana R., Lee Hopin, Mansouri Anita, Lohner Szimonetta, Saccilotto Ramon, Nury Edris, Chan An-Wen, Blümle Anette, Odutayo Ayodele, Hopewell Sally, Briel Matthias, Speich Benjamin, Gloy Viktoria L, Klatte Katharina, Gryaznov Dmitry, Taji Heravi Ala, Ghosh Nilabh, Marian Ioana R, et al. (2021), Reliability of Trial Information Across Registries for Trials With Multiple RegistrationsA Systematic Review, in JAMA Network Open
, 4(11), e2128898-e2128898.
Dhiman Paula, Ma Jie, Navarro Constanza Andaur, Speich Benjamin, Bullock Garrett, Damen Johanna AA, Kirtley Shona, Hooft Lotty, Riley Richard D, Van Calster Ben, Moons Karel G.M., Collins Gary S. (2021), Reporting of prognostic clinical prediction models based on machine learning methods in oncology needs to be improved, in Journal of Clinical Epidemiology
, 138, 60-72.
Background: Randomised controlled trials (RCTs) are at the top of classical text book evidence-based medicine pyramids. However, RCTs only reach their full potential if they are well conducted and reported. By “good reporting” we mean that all conducted RCTs are published, analysed as pre-specified, and that results are transparently reported adhering to the CONsolidated Standards of Reporting Trials (CONSORT) Statement. Clinical trial registries were set up to provide an overview of all ongoing RCTs, to pre-specify the most important study characteristics, and to minimize publication bias. However, it is still unclear how reliable the information on clinical trial websites is. Furthermore, a large amount of meta-research projects has concluded that the reporting in published RCTs is suboptimal; but clear strategies or interventions how to tackle this problem are missing. The proposed research has the following two objectives: (i) To assess the reliability of the RCT information on clinical trial websites, and (ii) to test in an RCT if a simple intervention (i.e. targeting peer reviewers) can improve the reporting quality in published RCTs.Methods: Objective 1: Based on a sample of 203 RCTs that are registered in more than one clinical trial registry we will evaluate the agreement between the different clinical trial registries for specific trial characteristics (i.e. date first patient enrolled, target sample size, recruitment status of trial, primary outcome, if results are available, main publication indexed, sponsor, and funder). We will conduct an exploratory sub-group analysis to assess if the agreement is different amongst industry-initiated RCTs compared to non-industry initiated RCTs.Objective 2: To test if reminding peer-reviewers of the most important and often poorly reported CONSORT items improves the reporting in published RCTs. We are currently conducting a RCT in collaboration with the BMJ Publishing Group and PLOS ONE, whereby I am daily screening submitted manuscripts for eligibility. Manuscripts presenting the primary results of an RCT, that are sent out for peer review, are randomised to the intervention (a short reminder of most important and poorly reported CONSORT items) or a control group (peer review as usual). The set-up of this RCT was complex and challenging leading to a delayed start. We have currently randomized XX manuscripts and are confident to successfully complete the trial (i.e. randomising articles until 166 articles are published) until September 2021. Relevance: Objective 1 has the potential to identify shortcomings of clinical trial registries. We will be in contact with managers from clinical trial registries to improve shortcomings in case some might be identified. Further, Objective 2 and the testing of a simple intervention aimed a peer reviewers has the potential to improve the reporting in published RCTs. This intervention could easily be implemented by journals if it is shown to be effective.