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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:

    Research plan

    Statistical analysis plan

    Information to study participants

    Insurance for study participants

    Study budget

    Registering your study

    Handling of personal data

    Health economics evaluation

    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

    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:

    Consent from study participants

    Access to information from medical records

    Collecting and managing data

    Specific rules for clinical trials with medicines or medical devices

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Statistical analysis plan

    Analysis population

    Replacement (imputation) of missing values

    Statistical analysis

    Adjustment analysis

    Subsidiary group analysis and interactions

    Sensitivity analysis

    Interim analysis

    Analysis database and analysis program

    Evaluating the result

    Writing a study report

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Writing a scientific article

    Selecting the journal

    Open access

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Personal data

    Specific rules for clinical studies using medicines

    Särskilda regler för läkemedel och medicinteknik

Idea

Read time 4 min

When you have an idea and want to find out whether it is sound, it is a good idea to start by making an inventory of what is already documented in the area. By carrying out a literature search and a review of registers and databases, you can map out the research status.

An idea can result from systematic research, but it can also arise spontaneously as a possible solution to an everyday problem. Within health and medical care, it is often a question of creative solutions to work methodology problems, or of new products that will contribute to the development of healthcare work. It is not uncommon either for research to be carried out into methods or interventions that are already in use, but lack scientific evidence for their effect, or to investigate whether therapies developed for a specific indication can also be used in other contexts.

Health and medical care or clinical research?

Health and medical care refer to measures aimed at preventing, investigating and treating diseases and injuries medically. Health and medical care shall be conducted according to science and tried-and-tested experience. The rules for how health and medical care shall be exercised are included in legislation, such as the Health and Medical Services Act (SFS 2017:30), the Patient Safety Act (SFS 2010:659) and the Patient Act (SFS 2014:821). For research, other rules apply, and the requirement for science and tried-and-tested experience do not apply to therapies tested within the framework for a clinical study. On this website, you can find information about what applies when you carry out a clinical study.

Compare your idea with previous research

By carrying out a literature search and review of scientific publications, registers and databases, you can compare your idea for a new method, therapy or product with previous research carried out, and possibly find similar products on the market. Perhaps there is clinical data from previous research that support your idea, or information on development of similar products? You can learn more about systematic searches of scientific literature from SBU (the Swedish Agency for Health Technology Assessment and Assessment of Social Services). You can also ask a librarian within your organisation or at your HEI for tips about databases and search strategies. The search words, the limits for the search and the search services you choose are of importance for determining the search results you will achieve.

There are a number of databases you can search to find information about clinical studies in progress or completed. Some of them are:

Search for knowledge among systematic analyses

HTA, Health Technology Assessment, entails a systematic assessment of the knowledge status for a medical method, technology or therapy. The method was first used by the US Office of Technology Assessment (OTA) in the early 1970s for the purpose of producing background information for decisions on introducing new technology. The assessment is made from financial, as well as organisational and ethical perspectives, and is based on a review of the published scientific literature, according to SBU’s principles for study quality. New technology is often compared to existing technology. The purpose of the HTA analysis is to make healthcare more evidence-based.

The assessments are carried out at national level by SBUexternal link, opens in new window and the Dental and Pharmaceutical Benefits Agency (TLV)external link, opens in new window , and at regional level by HTA organisations in Region Örebro, Västra Götaland Region, Stockholm County Council, Sydöstra Healthcare Region and Region Skåne.

Search for gaps in scientific knowledge

SBU carries out independent evaluations of methods within health and medical careexternal link, opens in new window including dental care. The reports describe the methods and interventions that make the greatest difference, and indicate the best way of using societal resources.

If you want help with understanding where the need for clinical research is the greatest, you can get tips about a large number of insufficiently evaluated methods and interventions in health and medical care and social services, or “gaps in scientific knowledge”. SBU has mapped areas where there is a need for more knowledge, based on SBU’s own reports, the national guidelines of the National Board for Health and Welfare and other systematic literature summaries. The identified gaps in knowledgeexternal link, opens in new window are published on SBU’s website, where you can search among lots of suggestions for research within a vast number of areas.

 

Use data found in registers

Public authorities have a large number of registers that have been collected within the framework for each authority’s activities. Several authorities have data from population-based surveys and questionnaires, which have been gathered together primarily for purposes other than research. Of particular interest to clinical studies are health data registers, for example.

Health and medical care in Sweden maintains a quality register, which has been built up within specific areas in order to develop and safeguard care quality systematically and continuously. The registers contain data linked to persons on subjects such as diagnosis, therapy and outcome of therapy. The quality registers can be used for research, for example to identify risk factors for disease and ill health in the population. Register studies can also be used to follow up and evaluate benefits and risks of various medicines and other forms of therapy.

At registerforskning.seexternal link, opens in new window , there is information aimed at researchers who want to use register data in their research. It provides support for the work of identifying, ordering and using register data.

Formulate the problem

The formulation of the problem is the core of every research process, and the clearer the problem and the primary question of the project is formulated, the clearer and more concrete the purpose of the project in question becomes. Once you have formulated a concrete research question, you can also determine the data that need to be collected in order to answer the question.

Your formulation of the research question forms the basis for the research plan that is needed for the application to the Ethical Review Board.

Särskilda regler för läkemedel och medicinteknik


Skapad: 2017-11-10
Senast uppdaterad: 2018-12-11 

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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