en
Dictionary:

Clinical studies - step by step

Clinical studies - step by step
  • Page contents:

    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

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    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?

    Specific rules for clinical trials with medicines or medical devices

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Applying for an ethical review

    Applying for authorisation from a radiation protection committee

    Setting up a biobank or getting access to biobank samples

    Finding out what applies for handling of personal data

    Registering your study before the study begins

    Specific rules for clinical trials with medicines or medical devices

    SKL and LIF – agreements and templates for clinical studies

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Study participants need to give written consent

    Collecting and managing study data

    What applies for changes to the study protocol after approval?

    Specific rules for clinical trials with medicines or medical devices

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    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

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Writing a scientific article

    Selecting the journal

    Publishing with open access

    Publishing the results in a public database

    Informing study participants of the study results

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Screening of personal data

    Specific rules for clinical studies using medicines

    Särskilda regler för läkemedel och medicinteknik

For researchers

The “For researchers” pages are primarily aimed at researchers who want to conduct or learn more about clinical studies. Here you can find information about the study process, different study types and the laws and regulations that govern the area.

To enable and offer the best possible healthcare and therapy, health and medical care needs to develop continuously. Swedish health and medical care is facing challenges such as an ageing population, demographic changes, lifestyle diseases and an increasing proportion of the population living with chronic medical conditions.

Clinical studies contribute to evidence-based development of health and medical care, and are a prerequisite for advances made within experimental basic research becoming of benefit to patients in the form of preventive and improved health and medical care, for example.

As a clinical researcher, you form a link between the laboratory and the patients, and you contribute to new and improved therapy methods that can benefit healthcare. Clinical researchers also enable:

  • knowledge from healthcare to be fed back into research (translational research)
  • increased knowledge among health and medical care personnel
  • the research climate to become competitive through collaboration between academia, industry and healthcare

Research or innovation?

An innovation entails a new or significantly improved product, service or method. It can also be a new marketing method, a new way of organizing business, work organization or external relations.

Sometimes this type of improvement is created through a research process, but it is only when the new product, service or method is established or implemented in a market that it becomes an innovation.


Skapad: 2017-11-07
Senast uppdaterad: 2018-11-13 

Contact

Office for Clinical Studies, Swedish Research Council

Östra Hamngatan 26
SE-411 09 Göteborg

 

Phone (Swedish Research Council, switchboard):
+46 (0)31 757 41 75

E-mail: kliniskastudier@vr.se

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Clinical Studies Sweden - a collaboration between The Swedish Research Council and the Swedish Association of Local Authorities and Regions.