Publication
Once the study results have been analysed, the next step is to compile and present them in a report, a scientific article or another relevant forum.
- Publish the research results
- Write a scientific article
- Choose a journal
- Publish with open access
- Publish the results in a public database
- Inform study participants that the study has ended
- Specific requirements for medicinal products and medical devices
- Reporting results from a clinical trial of a medicinal product
- Publishing results from a clinical investigation of a medical device
- Publishing results from a performance study of an in vitro diagnostic medical device
- Related information about Advanced therapy medicinal products (ATMPs)
Publish the research results
Medical research aims to improve human health. For the results to contribute to new knowledge and development, they need to be communicated clearly and reach the intended audiences.
Write a scientific article
Scientific articles make it possible to disseminate research results to other researchers, healthcare professionals and the general public. In the long term, the results may contribute to development and provide a basis for changes in healthcare.
Before a scientific article is published, it is usually reviewed by other researchers in the field through a process known as peer review. The purpose of the review is to assess the scientific quality of the research.
Write clearly and highlight the main message
A scientific article is more accessible when it is written in clear and understandable language. The article should:
- answer the scientific research question
- have a clearly formulated aim
- clearly communicate the main message of the study
Follow the journal’s instructions
The journal’s website provides instructions for authors. These usually specify:
- the types of articles accepted by the journal
- the headings that the article should contain
- how the article should be formatted
- the requirements for figures and tables
Structure of the article
A medical scientific article is often divided into:
- Introduction – Why was the study conducted?
- Methods – How was the study conducted?
- Results – What did the study show?
- Discussion – How can the results be interpreted?
Choose a journal
The choice of journal affects which audiences the research results reach and how they are disseminated.
When choosing a journal, consider:
- which journals are available in the subject area
- which audience you want to reach
- the journal’s scientific scope and impact.
It may be useful to choose a journal early in the publication process, as the journal’s scope and instructions affect how the article needs to be prepared.
Impact factor
Impact factor is a measure based on how frequently articles published in a journal are cited. Information about a journal’s impact factor is often available on the journal’s website and in dedicated databases of scientific journals.
Get help choosing a journal
You can contact a librarian within your organisation or at your higher education institution for help choosing a journal.
Publish with open access
Open access means that scientific publications are made available digitally and free of charge to everyone. If the research has received public funding, there may be requirements for the results to be published with open access.
Publish the results in a public database
Results from clinical trials must be registered in the public database in which the study was previously registered, regardless of the results of the trial.
Many scientific journals require a study to be registered in a public database before its results can be published. This may mean that clinical studies other than clinical trials of medicinal products also need to be registered.
- More information about how to register studies in the chapter Application
- The Clinical Trials Search Portal, World Health Organization External link.
Inform study participants that the study has ended
Study participants should be informed that the study has ended and about its results, in accordance with the written information they received before participating.
The Swedish Ethical Review Authority provides guidance on how information for study participants should be prepared.
Points to consider before publication
When preparing the study results for publication, consider the target audience, applicable requirements and the journal’s instructions.
- Which journal is appropriate for publishing the study results?
- Does the publication meet any open access requirements?
- Does the publication follow the selected journal’s instructions?
Specific requirements for medicinal products and medical devices
Specific requirements apply to the reporting and publication of results from:
- clinical trials of medicinal products
- clinical investigations of medical devices
- performance studies of in vitro diagnostic medical devices.
Under the relevant headings below, you will find information about final reports, reporting deadlines and the publication of results in public databases.
Reporting results from a clinical trial of a medicinal product
Clinical trials under Regulation (EU) No 536/2014
For a clinical trial conducted under Regulation (EU) No 536/2014, the sponsor must notify the completion of the trial through the Clinical Trials Information System (CTIS).
The sponsor must submit a notification within 15 days of the completion of the trial:
- in each participating Member State
- in all participating Member States.
Regardless of the outcome of the trial, the sponsor must submit the following through CTIS no later than one year after the trial has ended:
- a summary of the trial results
- a summary of the results written for laypersons.
For certain clinical trials involving children, the summary of results must be submitted within six months after the trial has ended.
Clinical trials under the previous Clinical Trials Directive
Different requirements apply to clinical trials that were registered in EudraCT, completed before 30 January 2025 and not transferred to CTIS.
For these trials:
- a summary of the trial results must be published in the EU database EudraCT
- a clinical study report must be prepared.
Information about completed clinical trials, Swedish Medical Products Agency website External link.
Publishing results from a clinical investigation of a medical device
Clinical investigations of medical devices are governed by the EU Medical Devices Regulation (EU) 2017/745 (MDR), which came into effect on 26 May 2021.
Prepare a final report
A final report must be prepared for every clinical investigation of a medical device. Guidance is available on the Swedish Medical Products Agency’s website.
The requirements for submitting the report depend on when the clinical investigation started:
- Clinical investigations started before 26 May 2021: Submission of the final report to the Swedish Medical Products Agency is not mandatory. However, the Agency may request access to the report in individual cases.
- Clinical investigations started on or after 26 May 2021: The final report must always be submitted to the Swedish Medical Products Agency. Requirements for the report’s content are set out in Annex XV to the MDR and Annex D to ISO 14155:2026.
The final report must present the data from the clinical investigation, analysed according to the plan specified in the Clinical Investigation Plan (CIP).
The report must be:
- reviewed by the participating investigators
- signed by the sponsor and the principal investigator
- signed by the coordinating investigator instead of the principal investigator in a multicentre investigation
The final report and a summary written in terms that are understandable to the intended user must be submitted to the Swedish Medical Products Agency no later than one year after the clinical investigation has ended.
If the investigation was terminated early or temporarily halted, the report must be submitted within three months.
Publish the results in public database
The results of a clinical investigation of a medical device must be registered in the public database in which the investigation was previously registered, regardless of the outcome.
Check whether the journal in which you intend to publish the results requires the investigation to be registered in a particular public database.
Medical devices for in vitro diagnostics (IVDR)
Publishing results from a performance study of an in vitro diagnostic medical device
Performance studies of in vitro diagnostic medical devices are governed by the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which came into effect on 26 May 2022.
Prepare a final report
For a clinical performance study of an in vitro diagnostic medical device, the sponsor must prepare a study report in accordance with:
- Annex XIII, Part A, Section 2.3.3 of the IVDR
- Annex D to ISO 20916:2024
The report must be approved and signed by the principal investigator or, for a multicentre study, by the coordinating investigator.
At a minimum, the report should include:
- the results of the study
- the conclusions
- any negative findings
The report should contain sufficient detail to enable an independent party to understand the study without referring to other documents.
The study report and a lay summary must be submitted to the Swedish Medical Products Agency no later than one year after the study has ended.
If the study was terminated early or temporarily halted, the documents must be submitted within three months.
Publish the results in a public database
The results of a clinical performance study must be registered in the public database in which the study was previously registered, regardless of the outcome.
Check whether the journal in which you intend to publish the results requires the study to be registered in a particular public database.
Related information about Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs) are biological medicinal products based on genes, cells or tissue engineering. ATMPs are regulated by common EU legislation supplemented by Swedish legislation.
The links below provide further information, regulatory guidance, templates and training.
- Advanced therapy medicinal products, Swedish Medical Products Agency website External link.
- Guides, templates and regulatory support, ATMP Sweden website External link.
- ATMP classification and regulatory information, European Medicines Agency website External link.
- Online course: Introduction to advanced therapies, Swedish Academy of Pharmaceutical Sciences website External link.
Research support for clinical trials involving advanced therapy medicinal products
Contact your regional node within Clinical Studies Sweden to find out what research support is available for your study.
Contact your regional node within Clinical Studies Sweden External link.
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