Work Package 6 Transparency and Registration

The following project on transparency and registration of clinical research has been awarded funds by the NTA board:

Project Title: Work Package 6, on Transparency and Registration

Project Period: 01.01.2014 – 31.12.2014

Project Leader: Christian Gluud, Head of Department, Copenhagen Trial Unit, Centre for Clinical Intervention Research.

Project update 9.4.2015

Report on Transparency and Registration in Clinical Research in the Nordic countries

Project update 8.1.2015

The WP 6 has collected and described procedures for transparency, i.e., registration and reporting of all clinical trials involving humans through the national networks and connections.

Alongside evaluating the accomplishment and deficiencies in the Nordic countries, the WP 6 has been keeping a close eye on the big momentum worldwide in the field of transparency, with new EU legislations for clinical research and data protection coming into force and the announced report from the U.S.A. Institute of Medicine (IOM).

The WP 6 has delineated the advantageous and disadvantages for the Nordics to embrace transparency. The group has developed procedures for how to comply with transparency demands. The drafting of the conclusions on how we best embrace transparency and how we should practice  it,  with supporting arguments and reasons, have been discussed at 3 meetings and on bimonthly telephone conferences.

For most Nordic countries open access policies are being drafted, considered, and implemented by the ministries.

Project summary

Clinical trials are investigations designed to assess the effects, beneficial and harmful, of healthcare interventions in humans. Decisions about health care should be based on systematic reviews of all evidence in order to be as accurate as possible. Failure to register and report all clinical trials and their results – especially non-efficacy results or harmful effects – means that all possible evidence is not available. Consequently, decisions about health care may be based on incomplete, wrong, or biased information. Registration and reporting of all clinical trials involving humans will also increase transparency for researchers and funding agencies, it will decrease the risk of unnecessary duplication, and it will also help to identify gaps in research.

Transparency levels in clinical trial reporting encompass: 1. knowledge that the trial is being conducted; 2. required details about design, methods, and outcomes; 3. required details about results; 4. summary of results; 5. depersonalised individual patient data. The Current work will be aimed towards raising the awareness of the hampered trial registration and reporting and towards finding possibilities to minimise double registration and reporting. We want to improved registration and reporting of clinical studies, interventional and non interventional, by raising the homogeneity and quality of what is registered and reported for all studies.

Background

Clinical trials are investigations designed to assess the effects, beneficial and harmful, of healthcare interventions. Decisions about health care should be based on systematic reviews of all evidence in order to be as accurate as possible. Failure to register and report all clinical trials and their results - especially non-efficacy results or harmful effects - means that all possible evidence is not available. Consequently, decisions about health care may be based on incomplete, biased, or wrong information. Registration and reporting of all trials will also increase transparency for researchers and funding agencies, it will decrease the risk of unnecessary duplication, and it will also help to identify gaps in research.

There are several public platforms available for registration of trials and reporting of results. The most well-known platform is ClinicalTrials.gov; a US-based government-owned public registry and results database of publicly and privately supported clinical studies. Also the EU Clinical Trials Register for medicinal products is now a public registry, but may still be problematic with lag times and not easily digestible information. All current public registries have different layouts, and there is incomplete consensus as to what elements or items must be reported. The most commonly followed are the WHO recommendations ('the 20 items') and the International Committee of Medical Journal Editors (ICMJE) recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. However, for the single investigator, or even for the industry, it is time consuming to digest all this information and stumble their way through all too many different application and registration systems in order to be able to conduct their clinical trial. There is a need for more smart systems to take you faster through the administrative hurdles of a trial, amongst other through easy to use standard operating procedures (SOPs).

The Nordic Trial Alliance (NTA) is a three-year pilot project running from 2013 to 2016, funded by the Nordic Council of Ministers and NordForsk.