Publication
Once the results of the study are complete, it is time to start writing your report or article for publication in a scientific journal or other forum.
Publish the research
Medical research aims to improve human health. To achieve this, research results must be communicated in a clear and understandable way and reach the intended audience.
Writing a scientific article
Scientific articles make it possible to disseminate research results to research colleagues, healthcare professionals and the general public. In the long term, the results can contribute to development and serve as a basis for change in healthcare.
Before an article is published, it is reviewed by other researchers in the field through a process known as peer review. The reviewers are subject-matter experts, and the review is conducted to ensure that the research meets a high scientific standard.
Write clearly and highlight the message
A scientific article becomes more accessible when it is written in clear and straightforward language. The article should:
- provide a clear answer to the scientific research question
- have a clearly formulated aim
- clearly convey its main message
Follow the journal’s instructions
The websites of scientific journals provide detailed instructions for authors regarding:
- what types of publications the journal accepts
- which headings should be included
- how the publication should be formatted
- which rules apply to figures and tables
Structure of the article
A typical medical scientific article is often structured as follows:
- Introduction – Why was the study conducted?
- Methods – What was done?
- Results – What were the outcomes?
- Discussion – What do the results mean?
Choosing a journal
Choosing the right journal is an important part of the publication process. The choice affects how well the research results are disseminated and to whom.
Consider the following when choosing a journal
- which journals exist within the subject area
- how best to reach the target audience
- the journal’s impact factor
The choice of journal should be made as early as possible so that the manuscript can be adapted from the outset. The choice is guided by the strength of the message, meaning both the scientific quality and the novelty of the results.
Impact factor
Journals are ranked according to how often their articles are cited; this is referred to as the impact factor.
The International Scientific Institute provides searchable lists of impact factors for indexed journals. Information on impact factor is also often available on the journals’ own websites.
Get help choosing a journal
You may wish to seek advice and support from a librarian within your organisation or higher education institution when choosing a journal.
Publish with open access
Open access means that scientific publications funded by public resources should be made digitally available to everyone, free of charge.
National guidelines for open access to scientific information is available on the website of the Swedish Research Council. You can read more about open access and open archives at Swedish HEIs on the website of the National Library of Sweden.
Publishing the results in a public database
Results from clinical trials must be registered in the public database where the study was previously registered – regardless of the study outcome.
Many scientific journals require studies to be registered for the results to be eligible for publication. In practice, this means that there is a registration requirement even for studies that are not clinical trials of medicinal products.
- More information about how to register studies in the chapter Application
- The Clinical Trials Search Portal, World Health Organization External link.
Informing study participants of the study results
Study participants should be informed that the study has been completed and about the study results, in accordance with what is stated in the written information provided to participants.
The Swedish Ethical Review Authority has developed guidance on how information to study participants should be designed.
More information and support:
Points to consider
- 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 rules for medicinal products and medical devices
There are specific rules to attend to regarding clinical investigations of medical devices.
EU Regulation (EU) No 536/2014
For clinical trials of medicinal products conducted under Regulation (EU) No 536/2014, the following applies:
The sponsor shall notify via CTIS within 15 days that the trial has been completed:
- in each participating Member State
- in all participating Member States
Within 1 year after completion of the trial, the sponsor shall submit via CTIS:
- a summary of the trial results
- a summary of the results written for laypersons
This applies regardless of the results obtained in the trial.
For clinical trials involving children, where:
- the investigational medicinal product is authorised, and
- the sponsor is the holder of the marketing authorisation (MAH),
the summary of the results shall be submitted within 6 months after completion of the trial.
Previous EU Directive 2001/20/EC
For clinical trials that have been registered in EudraCT and completed before 30 January 2025 (and not transferred to CTIS) shall:
- Summary of the results of the clinical trial must be published in the EU database (EudraCT)
- A clinical study report be prepared
Information about completed trials, Swedish Medical Products Agency website External link.
Medical devices in the EU are divided into two regulatory categories, each following different regulations. For medical devices, the EU Regulation on Medical Devices (MDR) applies. New regulations came into effect within the EU from May 26, 2021, and additional regulations apply in Sweden from July 15, 2021.
Writing a final report
For medical technical clinical trials, a final report must be written according to instructions on the Swedish Medical Products Agency's website.
The final report does not need to be submitted to the Swedish Medical Products Agency for trials that have begun before the application of the EU regulation on medical devices (26 May 2021). The Swedish Medical Products Agency may, however, specifically request access to the final report.
Final report for trials that begin after application of the EU regulation on medical devices (26 May 2021) must always be submitted to the Swedish Medical Products Agency.Guidelines for the content of the report are available in EU regulation on medical devices, Appendix XV and in ISO 14155:2020, Annex D.
The written final report shall include study data analysed in accordance with what has been previously defined in the clinical trial plan. The final report shall be reviewed by the participating investigators, and the final report shall be signed by the sponsor and principal investigator, or the coordinating investigator for multi-centre studies. The report and an easy-to-understand summary shall be submitted to the Swedish Medical Products Agency latest one year after the end of the clinical trial, or latest after three months if the trial was terminated prematurely or suspended.
Publish the results in a public database
Results from clinical investigations of medical devices shall be registered in the public database, where the study was previously registered, regardless of the results. Review whether the journal you intend to publish in has specific requirements for registration in a specific database.
Medical devices for in vitro diagnostics (IVDR)
Medical devices in the EU are regulated and divided into two categories that follow different frameworks. For in vitro diagnostic medical devices, the EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) applies. New regulations came into effect within the EU from May 26, 2022.
Writing a final report
For clinical performance studies on in vitro diagnostic products, a study report must be written in accordance with the EU regulation on medical devices for in vitro diagnostics, Annex XIII, Part A section 2.3.3 and Annex A in ISO 20916: 2019.
A study report must be signed by a doctor or another responsible competent person and must, among other things, contain results and conclusions of the study, including negative results. The report shall contain so much information that an independent party shall be able to understand it without reference to other documents.
The report and an easy-to-understand summary must be sent to the Swedish Medical Products Agency within one year after a clinical performance study has been completed or no later than three months after it has been terminated prematurely or temporarily interrupted.
Publish the results in a public database
Results from clinical performance studies must be recorded in the public database, where the study was previously registered, regardless of the results. Review whether the journal you intend to publish in has specific requirements for registration in a specific database.
Related information about ATMP
ATMP (Advanced therapy medicinal products)
Advanced therapy medicinal products (ATMP) are human medicines, based on genes, tissues or human cells. They offer ground-breaking new opportunities for the treatment of diseases and injuries. More information about advanced therapy:
For guide/templates and regulatory guide, ATMP project website External link.
Classifications, regulatory information, European Medicines Agency website External link.
Published: