Register clinical studies in ClinicalTrials.gov
Interventional and non-interventional clinical studies should be registered in a clinical trial registry. ClinicalTrials.gov is the most common registry where researchers register their clinical studies.
Introduction
A clinical study is defined by ICMJE as: "Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes."
One of the most common clinical trial registries where researchers register their clinical studies is ClinicalTrials.gov. In ClinicalTrials.gov, interventional and non-interventional clinical studies can be registered. A clinical study can be divided into two categories in ClinicalTrials.gov:
- 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.
- 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.
In cases where it is uncertain whether a clinical study meets the ICMJE definition, researchers should verge on the side of registration if the subsequent plan is to publish in an ICMJE journal. That is because many journals require that a clinical study is registered in a clinical trial registry before the first patient/participant is recruited, or as soon as possible afterwards, in order for a study to be published.
Create an account in ClinicalTrials.gov
In ClinicalTrials.gov, KI has an organization account under which all registered studies that have KI as a sponsor (huvudman) are registered. The organization account is managed by a so-called PRS Administrator and at KI that role lies with Compliance & Data Office (CDO).
If the study has several sponsors (huvudmän), you need to decide within the project which sponsor will be responsible for registering the clinical study in a clinical trial registry.
To create a new users account in ClinicalTrials.gov, the researcher must contact CDO by sending an email to compliance@ki.se. CDO needs the following information in order to create an account:
- Name of the researcher(s) that needs an account and specify who is the PI for the study
- Email address and phone numbers of everyone who needs an account
- Ethical application (so we can verify that KI is sponsor/responsible registrant)
When the account is created, you will receive information from ClinicalTrials.gov with login details and an email from CDO with more detailed information.
Register a new clinical study
When registering a new clinical study in ClinicalTrials.gov there are certain mandatory fields to fill in. Below is an explanation of what some of those fields mean:
- Record Owner: This can be the responsible researcher (referred to as principal investigator [PI] in ClinicalTrials.gov), or a researcher assigned by the PI. If the record owner is not the PI, then the PI must be added to the “access list” in order to “approve” and “release” the protocol registration to NIH for review.
- Unique Protocol ID: This can either be a grant number received for the study protocol by the funding agency, the Dnr number from the ethical approval, or the acronym of the study (if the other two identification numbers are unavailable).
- Sponsor: Karolinska Institutet must be listed as the Sponsor.
- Responsible Party: The PI must be listed as responsible.
Maintaining updates
All studies that are registered in ClincialTrials.gov must be updated at least once a year, even if nothing new has happened. The person listed as Record Owner for the study will receive an email from ClinicalTrials.gov when it’s time to do the update.
Reporting of results
A researcher is not required by law to report results for clinical studies that has been registered in ClinicalTrials.gov, unless there are requirements from research funders and regulatory authorities or is an “applicable clinical trial (ACT)” in accordance with the FDA ACT 2007. However, Karolinska Institutet strongly recommends reporting results in ClinicalTrials.gov after study completion to ensure transparency.
The process of sending in results information to ClinicalTrials.gov is almost the same as preparing a manuscript for publication in a journal. A person familiar with the study design and the data analysis needs to be involved to accurately summarize the results information in the tabular format required by US law and to ensure that the results correspond to the ClinicalTrials.gov review criteria. Scientific information is provided as four separate modules, which includes:
- Participant Flow: Demonstrates how participants were assigned to the arms or groups of a study and how they progressed through the stages of the study.
- Baseline Characteristics: Includes demographics and study-specific measurements.
- Outcome Measures and Statistical Analyses: Summarizes results data, by arm or comparison group, for each primary and secondary outcome measure assessed in the study.
- Adverse Events: Includes three tables summarizing expected and unexpected adverse events.
All mandatory fields must be filled out and it is the principal investigator, the so called “Responsible party”, that needs to make the final approval before the results are submitted for review by ClinicalTrials.gov. The review can take up to 30-60 days before the study results are approved and made public by ClinicalTrials.gov. Results must be reported within 12 months after study completion.
Please note, adding a link to the publication from PubMed does not meet the requirements for summary results reporting in ClinicalTrials.gov.
Clinical studies funded by the Swedish Research Council (Vetenskapsrådet)
The Swedish Research Council (Vetenskapsrådet) has new guidelines from 2022 stating that all clinical studies/trials funded by the Swedish Research Council must be registered in a public clinical trial registry.
It is Karolinska Institutet’s responsibility to make sure the PI of the study is registering and updating the study. Affected researchers will therefore be contacted by CDO with information and guidance.
Read more on the Swedish Research Council’s webpage.