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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.

  • Health and medical care or clinical research?

    Compare your idea with previous research

    Search for knowledge among systematic analyses

    Search for gaps in scientific knowledge

    Use data found in registers

    Formulate the problem

    Good things to consider

    Specific rules for medicinal products or medical devices

    Links and related information

  • The design and method of the study are important

    A research plan is necessary for ethical review applications, and functions as a handbook

    Statistical analysis plan

    Information to study participants before consent

    Find out what insurance cover is available for the study participants

    Study budget for all the costs in the project

    Is a health economics evaluation of the study needed?

    Checklist to help plan studies on human

    To consider

    Specific rules for medicines and medical devices

    Links and related information

  • Applying for an ethical review

    Research projects in which study participants are irradiated

    Application for access to biobank samples

    Finding out what applies for handling of personal data

    Register your study before the start of the study

    Agreement on the conduct of clinical studies

    Keep in mind

    Specific rules for medicines and medical devices

    Links and related information

  • Study participants need to give written consent

    Collecting and managing study data

    What applies for changes to the study protocol after approval?

    Please consider

    Specific rules for medicines and medical devices

    Links and related information

  • Planning before the study begins determines how data is handled and analysed

    Studies with a confirmatory purpose

    Studies with an exploratory purpose

    Data handling when the study is concluded

    Analysis of study data

    Specific rules for medical devices

    Links and related information

  • Public documents must be archived

    Screening of personal data

    To consider

    Specific rules for medicinal products and medical devices

    Links and related information

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 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.

Searchable lists of the impact factors of indexed journals, website of the International Scientific Institute External link.

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 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.

National guidelines for open access to scientific information, website of Swedish Research Council External link.

Open access and open archivesat Swedish HEIs, website of the National Library of Sweden External link.

Publishing the results in a public database

Results from clinical trials must be registered in the public database where the study was initially registered, regardless of the outcomes. Many scientific journals require studies to be registered for the results to be eligible for publication. In practice, there is therefore a registration requirement even for studies that are not medicine studies (you can find more information about how to register studies in "Application").

The Clinical Trials Search Portal, World Health Organization. External link.

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)

To consider

  • 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 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 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.

EU regulation on in vitro diagnostic medical devices, European Medicines Agency's website External link.

ISO 20916: 2019, SIS' website External link.

Links and related information

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