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Improving the reporting in randomised clinical trials: How reliable are clinical trial registries and how efficient is the use of reporting checklists for peer reviewers?

Applicant Speich Benjamin
Number 194496
Funding scheme Return CH Postdoc.Mobility
Research institution Institut für klinische Epidemiologie und Biostatistik Universitätsspital Basel
Institution of higher education University of Basel - BS
Main discipline Methods of Epidemiology and Preventive Medicine
Start/End 01.10.2020 - 30.09.2021
Approved amount 124'709.00
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Keywords (5)

Publication bias; Reporting; Randomised clinical trials; Clinical trial registers; Quality

Lay Summary (German)

Lead
Die Berichtqualität von randomisierten kontrollierten Studien (RCT) ist oftmals mangelhaft. Klinische Studienregister können dabei helfen, einen Überblick über laufende RCTs zu bekommen. Im vorliegenden Projekt werden wir überprüfen wie zuverlässig klinische Studienregister-Einträge sind. Des Weiteren werden wir eine Intervention testen, die die Berichtqualität der publizierten RCTs verbessern soll.
Lay summary

Im klinischen Alltag muss fortlaufend entschieden werden, welche Behandlungsmöglichkeit bei Patienten angewendet werden soll. Ergebnisse von randomisierten kontrollierten Studien (RCT) liefern in der Regel die zuverlässigste Evidenz als Grundlage für solche Entscheidungsprozesse. Leider sind nicht alle RCTs von hoher Qualität. Oftmals ist bereits das Studienprotokoll lückenhaft. Des Weiteren werden nicht alle RCTs in den offiziellen Registern vermerkt und viele werden nie publiziert. Selbst bei publizierten RCTs bleiben wichtige Punkte des Studiendesigns oftmals unklar. Dies ist aus ethischer Sicht bedenklich und eine gravierende Ressourcenverschwendung.

Im vorliegenden Projekt werden wir analysieren wie zuverlässig die Einträge in Studienregister sind. Wir haben dazu 200 RCTs identifiziert, welche in mehreren Studienregistern eingetragen sind. Für diese Studien, werden wir überprüfen ob spezifische Studiencharakteristika (z.B. Stichprobengrösse, Datum wann der/die erste PatientIn randomisiert wurde, Status der Studie, primärer Endpunkt, Sponsor und Geldgeber) in den verschiedenen Registern identisch sind.

In einem weiteren bereits laufenden Teilprojekt werden wir eine Intervention testen, die die Berichtqualität der publizierten RCTs verbessern soll. Dazu werden einige zufällig ausgewählte Reviewer (Experten die eine zur Publikation eingereichte Studie beurteilen und Verbesserungsvorschläge machen) eine Checkliste der wichtigsten Punkte, die in einer publizierten RCT enthalten sein sollten, erhalten. Anhand der publizierten RCTs werden wir dann überprüfen, ob diese Intervention erfolgreich war.

Direct link to Lay Summary Last update: 22.06.2020

Responsible applicant and co-applicants

Employees

Publications

Publication
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®
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.
Reliability of Trial Information Across Registries for Trials With Multiple RegistrationsA Systematic Review
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.
Reporting of prognostic clinical prediction models based on machine learning methods in oncology needs to be improved
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.

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Joint Annual Meeting 2021 of the Swiss Societies for Infectious Diseases (SSI), Hospital Hygiene (SSHH) with fibs/SIPI, Tropical Medicine and Parasitology (SSTMP) and the Tropical and Travel Medicine (SSTTM). Talk given at a conference A trial platform to assess approved SARS-CoV-2 vaccines in immunocompromised patients: A pilot trial comparing the mRNA vaccines Comirnaty® and Covid-19 mRNA Vaccine Moderna 02.09.2021 Montreux, Switzerland Speich Benjamin;


Abstract

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.
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