Reporting results in a clinical trial registry
Reporting results in a clinical trial registry can be a demanding task. Karolinska Institutet (KI) has implemented measures to ensure researchers are provided with regulatory information and support for reporting results in both EudraCT and ClinicalTrials.gov.
Researchers have ethical and legal obligations to report results for clinical trials and clinical studies. The paramount goal is to ensure summary results are reported timely and accurately in clinical trial registries. With the rise of clinical trial transparency and open science, Karolinska Institutet (KI) has implemented significant measures to ensure trial/study registrations and results are up-to-date and accurate. The Compliance & Data Office (CDO) provides support for researchers to report their results in both ClinicalTrials.gov and EudraCT.
Reporting results for clinical studies in ClinicalTrials.gov
The process of submitting results information to ClinicalTrials.gov is conceptually similar to preparing a manuscript for publication in a journal. An individual familiar with the study design and data analysis will need to be involved to accurately summarize the results information in the tabular format required by US law, and to ensure that the results are consistent with the "ClinicalTrials.gov review criteria". Scientific information is submitted as four separate modules, including:
- 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 measures.
- 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 anticipated and unanticipated adverse events.
All stipulated modules allow for the entry and display of information in a series of data tables with supporting notes, however, narrative conclusions about the results are not required. Once summary results are completed, the lead researcher (PI) must approve and release the study for NIH review. The review can take up to 30-60 days before the study results are approved and made public on the ClinicalTrials.gov database. Results must be reported within 12 months of the Primary Outcome Completion date.
It is important to note that adding a link of the publication from PubMed does not fulfill the requirements of summary results reporting in ClinicalTrials.gov. A full tutorial on reporting results in ClinicalTrials.gov can be accessed on the "PRS Guided Tutorials" website.
Reporting results for clinical trials in EudraCT
In order to report results in EudraCT, researchers must first create an account and register as a "results user". Results are divided into six separate modules.
- Trial Information: Includes information regarding general information about the trial, Sponsorship, regulatory details, and trial subjects.
- Subject Disposition: Includes the recruitment process of subjects and description of intervention arms.
- Baseline Characteristics: Includes demographic information of study subjects.
- End Points: Includes a description of outcome measures and results.
- Adverse Events: Includes information for adverse events, serious adverse events, and non-serious adverse events.
- Additional Information: Includes information regarding protocol amendments, study limitations, and caveats.
In EudraCT, summary results can be submitted for clinical trials that ended on or before 21 July 2013. For summary results, researchers can upload an abstract, if the clinical trial has been published in a peer-reviewed journal, and a link to the study. Clinical trials completed after the above-mentioned date must complete the full dataset form.
Once registered as a "results user", a results form template will be generated by the EudraCT system. The form will have fixed fields with information from the trial protocol and the six modules mentioned above. This is the full dataset where results are reported. All fields with asterisk must be completed. Once the full dataset is completed, researchers have the option to upload their full anonymized database to share their data, however, this is not obligatory. Anonymized databases can be uploaded in an xml-file. Once all fields are completed, press the "post results" button at the top of the page. The results will be processed, and upon approval, EudraCT will post the results to their database. It is very important to inform the Medical Products Agency (MPA) that the clinical trial has been completed. Otherwise, the clinical trial will incorrectly have the status 'ongoing', when in fact it is 'completed'. Detailed instructions for reporting results in EudraCT can be accessed on the "Tutorials on posting results in EudraCT" website.
Resources for reporting results
Information and procedures for reporting results in ClinicalTrials.gov and EudraCT are accessible by downloading "KI's Clinical Trial Registration & Reporting (CTRR) Instructions" document using the link below. Hands-on support for reporting results is also provided by CDO. Researchers can schedule an appointment for a one-hour online session for reporting results by accessing the "Support: make an appointment" webpage.