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.
The main purpose of medical research is to improve human health. In order to achieve this purpose, the results from research need to be communicated in an understandable way, and to reach the correct recipient.
Writing a scientific article
By means of scientific articles, research results can be disseminated to researcher colleagues, healthcare personnel and the general public, and generate further development in the long term and function as a basis for changes in healthcare. Before scientific articles are published, they are scrutinised using peer review. The persons scrutinising the article are experts in the subject area, and the scrutiny is carried out to ensure the research is of a good scientific standard.
It is an advantage if the article is written using simple language, and gives a clear answer to the scientific question. Being clear with both the message and what you want to disseminate facilitates matters for both the readers and the author.
The websites of journals have detailed instructions for authors, including the type of publications the journal can receive, what headings should be included, information on how the publication shall be formatted, and the rules that apply for any figures or tables. A typical medical scientific article is divided up into introduction, method, result and discussion, and answers the questions:
- Why was the study conducted?
- What was done?
- What were the results?
- What is the importance?
Selecting the journal
Selecting the journal is an important part of the publication process. Important factors to consider are:
- What journals exist within the subject area?
- How can the target group best be reached?
- What is the impact factor of the journal?
The choice of journal is directed by the strength of the message, that is to say both the scientific strength and the novelty value. It is a good idea for the selection of journal to be done as early as possible, so that the design is right from the start.
Journals are ranked according to how often their articles are cited, that is to say according to their impact factor. The International Scientific Institute External link.has searchable lists of the impact factors of indexed journals. You can also often find information about impact factor on the journals’ own websites. You can also ask a librarian within your organisation or at your HEI for advice and help in selecting a journal.
Publishing with open access
Publishing with open access means that scientific publications that are financed by public funds are accessible to everyone, in a digital format and free of charge.
National guidelines for open access External link. to scientific information is available on the website of the Swedish Research Council. You can read more about open access and open archives External link. at Swedish HEIs on the website of the National Library of Sweden.
Publishing the results in a public database
Many respected scientific journals require studies to be registered in order for the results to be approved for publication. In practice there is thus often a registration requirement even for studies that are not medicine studies. Many databases also require the study results to be reported, to avoid selective publishing, for example.
Informing study participants of the study results
Study participants should be informed about the conclusion and results of the study according to what has been stated in the information to study participants. On the Ethical Review Authority‘s website there is Guidance for information to study participants.
Information to study participants before consent
Guidance for information to study participants, the Ethical Review Authority's website External link.
Template for study participant information from Clinical Studies Sweden (in Swedish) External link.
- What journal is suitable for publishing the study results?
- Does the publication fulfil any requirement for open access?
- Does the publication follow the instructions of the selected journal?
Specific rules for medicinal products or medical devices
There are specific rules to attend to regarding clinical investigations of medical devices.
Medical devices are in the EU regulated by two categories that follow different regulations:
For medical devices, the EU Regulation on Medical Devices (MDR) applies. New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021.
For in vitro diagnostic medical devices, the EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) applies. New rules apply within the EU from 26 May 2022.
Medical devices, EU regulation MDR
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, EU regulation IVDR
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.
EU regulation on in vitro diagnostic medical devices, European Medicines Agency's website External link.
Links and related information
International Scientific Institute’s list of impact factors External link.
Information on national guidelines for open access, Swedish Research Council's website External link.
Information on open access and open archives, National Library of Sweden's website External link.
Guidance for information to study participants (in Swedish), Ethical Review Authority's website External link.
Links medical devices
Instructions to final report, Medical Products Agency's website External link.
The EU regulation on medical device products, EUR-Lex website External link.
Standards, SIS' website (login required) External link.
EU regulation on in vitro diagnostic medical devices, EUR-Lex website External link.
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.
About the product area: advanced therapy and joint links (in Swedish), Swedish Medical Products Agency’s website External link.
E-course: Introduction to advanced therapies (in Swedish), Swedish Academy of Pharamceutical Sciences website External link.