Clinical trials and clinical studies that require registration

The Medical Products Agency (MPA) provides a list of criteria to determine if a study meets the requirements of a 'clinical trial'. Studies that qualify as a 'clinical trial' must be registered in CTIS (New! More info below). The criteria for 'clinical studies' are based on the definition developed by the International Committee of Medical Journal Editors (ICMJE). Clinical studies are registered in ClinicalTrials.gov or a similarly approved WHO clinical registry.

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Clinical trials that require registration in CTIS (formerly EudraCT)

Clinical trials testing investigational medicinal products (IMP) must be registered in CTIS (formerly EudrCT, see information below) and be approved by the Swedish Medical Products Agency (MPA). The MPA defines a clinical trial as the following:

“Any study performed on humans to determine or confirm the clinical, pharmacological or pharmacodynamic effects of one or more investigational medicinal products, to identify adverse reactions to one or more investigational medicinal products or to study the absorption, distribution, metabolism and excretion of one or more investigational medicinal products, in order to ensure the safety or efficacy of those medicinal products”.

Trial drugs can be those that are under development or those that are already approved. The MPA provides a series of criteria to determine if the study is considered a clinical trial that must be registered and approved by the MPA. Researchers can assess if their study qualifies as a clinical trial that requires MPA approval on the MPA website about definition and criteria.

Clinical studies that require registration according to ICMJE

In order to determine if a clinical study (non-IMP trial) requires registration, the International Committee of Medical Journal Experts (ICMJE) has developed an expanded definition of a clinical study adopted from the World Health Organization (WHO):

“Any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes.”

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If a study meets one of these criteria for a clinical study, then registration is required. In cases where it is uncertain whether if a study meets the ICMJE definition, then researchers should verge on the side of registration if the subsequent goal is to seek publication in an ICMJE journal. Information regarding the definition of a clinical trial vs. clinical study can be found on the "Definition of clinical trials vs. clinical studies" webpage.

Studies that can be registered in ClinicalTrials.gov

In ClinicalTrials.gov, interventional and non-interventional clinical studies are permitted to be registered. A clinical study can be classified into two categories in ClinicalTrials.gov: Interventional study and Observational study. The following is the definition of both types:

  1. Interventional study: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
  1. Observational Study: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.

Studies that can be registered in CTIS

From 31 January 2022, a new EU-common regulation will come into application, Regulation EU 536/2014, also called Clinical Trials Regulation. This means that from 31 January, new clinical trials will be registered in CTIS (Clinical Trials Information System), instead of EudraCT.

In CTIS, only clinical trials testing IMPs in at least one site within a Member State in the European Union can be registered. Clinical trials are classified under one category in CTIS: Interventional study. The following is the definition of an interventional study in CTIS:

  1. Interventional study: Includes only interventional clinical trials using investigational medicinal products (IMP) conducted in the EU/EEA or outside the EU/EEA if they are part of an agreed PIP (Pediatric Investigation Plan).

Studies that can be registered in EudraCT

From 31 January 2022, a new EU-common regulation will come into application, Regulation EU 536/2014, also called Clinical Trials Regulation. This means that from 31 January, new clinical trials will be registered in CTIS (Clinical Trials Information System), instead of EudraCT.

In EudraCT, only clinical trials testing IMPs in at least one site within a Member State in the European Union can be registered. Clinical trials are classified under one category in EudraCT: Interventional study. The following is the definition of an interventional study in EudraCT:

  1. Interventional study: Includes only interventional clinical trials using investigational medicinal products (IMP) conducted in the EU/EEA or outside the EU/EEA if they are part of an agreed PIP (Pediatric Investigation Plan).

Clinical studies funded by Swedish Research Council (Vetenskapsrådet)

The Swedish Research Council (Vetenskapsrådet) has from 2022 new guidelines stating that all clinical trials funded by the Swedish Research Council must be registered in a public register/database, for example ClinicalTrials.gov. The study shall be registered before recruitment of patients begins and also applies to studies that started before they were granted funding by the Swedish Research Council.

It is Karolinska Institutet who is responsible that the PI of the study is registering and updating the study. Affected researchers will therefore be contacted by Compliance & Data Office for information and guidance.

Read more on the Swedish Research Council’s webpage.

More information

For more information regarding registration requirements and criteria, researchers can access “Criteria for Clinical Studies in ClinicalTrials.gov”, "Criteria for Clinical Trials in CTIS" and “Criteria for Clinical Trials in EudraCT” on the respective website.