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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

Application

Read time 4,5 min

It is easier to apply for authorisation for a clinical study if thorough preparations have been made and there is a well worked out and detailed research plan. Once the research plan is completed, you must apply for authorisation from the ethical review board and in many cases also from the Medical Products Agency.

Applying for an ethical review

If you are planning to carry out research on living and/or deceased persons, on biological material from humans, or research that involves handling sensitive personal data, you must apply for and have your research ethically reviewed and approved by a regional ethical review board. In order to formulate your application as well as possible, it is important to know the starting points for the ethical review.

According to the Act concerning the Ethical Review of Research Involving Humans, research may only be approved if:

  • it can be conducted with respect for human dignity
  • human rights and fundamental freedoms have been taken into account, at the same time as consideration has been paid to the interest in the development of new knowledge through research
  • the well-being of humans has been considered and given priority ahead of the needs of society and science
  • the risks it may entail to the health, safety and personal integrity of participants are outweighed by the scientific value
  • it is to be conducted by, or under the supervision of, a researcher who possesses the necessary scientific competence

An application of ethical review (pdf, 74 kB)external link, opens in new window shall be made on a special form available from the website of the ethical review boards. There you can also find guidelines for application (pdf, 174 kB)external link, opens in new window.

An ethical review is carried out only once the application is complete, which means that the form has been filled in correctly, the fee has been paid and all information requested has been submitted. The administration time for an ethical review board is approximately 60 days. The cost of applying for an ethical review is currently between 5 000 SEK and 16 000 SEK.

SKL, the Swedish Association of Local Authorities and Regions, and LIF, the Swedish Association of the Pharmaceutical Industry, have developed generic templates (in Swedish)external link, opens in new window for resource certificates and CVs that may be used in the application.

Applying for authorisation from a radiation protection committee

In medical, dental or biomedical research projects where the participants are irradiated, the study shall be approved by a radiation protection committee. The application shall be sent to the radiation protection committee in the same region as the decision-making regional ethical review board. For multi-centre studies, it is sufficient for the project to be assessed by one radiation protection committee. Other participating hospitals then only need to ensure that they can live up to the dose restriction set. The main application form (doc, 28 kB, in Swedish)external link, opens in new window can be found on the website of the ethical review boards. The website also has forms relating to:

Setting up a biobank

Biobank samples cover all areas from liquids, such as blood, serum, plasma and saliva, to faeces samples and tissue samples, such as biopsies, tumours and excised organs. The Biobanks in Medical Care Act applies for human tissue or cell samples if they are saved for longer than two months, except when the sample has been used for research, when it is a biobank sample irrespective of the storage period. It must always be possible to trace a biobank sample back to the sample provider, and it must always be stored in a biobank.

Advice in conjunction with planning a research study and the process of using application templates, design of patient information and the biobank sections of the ethical review application is offered in several locations in Sweden, both by biobank coordinators and the regional biobank centre. The Swedish National Biobank Board’s website has links to current resources for biobank services. The university hospitals also has centres for collaboration between universities and county councils/regions that can provide targeted support to research.

A biobank application is required in order to use biobank samples in research. Information, guidelines and checklistsexternal link, opens in new window are available on the website of the Swedish National Biobank Board.

Specific rules for clinical trials with medicines or medical devices

Applying for authorisation for a medicine study

The purpose of clinical studies involving the investigation of a new medicine may be to discover or verify clinical and pharmacological effects, to identify any side-effects and/or to study its absorption, distribution, metabolism and excretion. If your planned medicine study is a therapy study, then authorisation from the Medical Products Agency is always required. If your planned study is an observation study without any experimental features, then only approval from an ethical review board is required.

For guidance whether your planned study requires authorisation, you can use the Medical Products Agency’s test (pdf, 154 kB, in Swedish)external link, opens in new window.

The European database for clinical medicine studies, EudraCT, constitutes a register of all medicine studies carried out within the EU, and each study is identified by means of a unique number, a “EudraCT number”. This number is downloaded via EudraCT’s websiteexternal link, opens in new window and is the first step in an application to the Medical Products Agency. Once the EudraCT number has been downloaded, an electronic application form can be created at the Medical Products Agency. The application to the Medical Products Agency shall be supplemented with appendices, among them a study protocol, product information and a list of studies in progress with the same substance and safety evaluation. The Medical Products Agency’s website has a step by step guid (in Swedish)external link, opens in new window to the application.

If the ethical review board has reached a decision on the study in question, the decision shall accompany the application. If not, the sponsor shall make sure the decision is sent to the Medical Products Agency as soon as possible. The decision must have been received by the Medical Products Agency no later than 15 days after the sponsor has received the decision.

Registering a study using medical devices

For clinical studies involving a medical device, the procedure is different. Clinical studies involving non-CE-marked medical devices or medical devices that are CE-marked for other use than that intended in the study shall be registered by the Medical Products Agency. A clinical study of medical products within the CE-marked indication do not have to be registered.

The application shall be sent to the Medical Products Agency in electronic formatexternal link, opens in new window. Detailed instructionsexternal link, opens in new window are available on the Medical Products Agency’s website. The application shall be supplemented with appendices.

SKL and LIF – agreements and templates for clinical studies

In Sweden, collaboration has long been in place between health and medical care, universities, HEIs and the pharmaceutical industry in relation to the development of new medicines and follow-up after their introduction to medical care.

SKL, the Association of Swedish Local Authorities and Regions, and LIF, the Swedish Association of the Pharmaceutical Industry, have a joint agreemen (in Swedish)external link, opens in new window on the implementation of clinical therapy studies and observation studies in Sweden.

The Swedish Pharmaceutical Society’s clinical trials section has produced generic study templates (in Swedish)external link, opens in new window together with LIF and the Medical Products Agency, which can be used for the implementation of clinical studies.

Särskilda regler för läkemedel och medicinteknik

To consider

  • Has the application to the ethical review board been completed correctly?
  • Does the study need authorisation from the Medical Products Agency?
  • Does the study need authorisation from a radiation protection committee?
  • Does a biobank need to be set up?

Skapad: 2017-11-13
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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Clinical Studies Sweden - a collaboration between The Swedish Research Council and the Swedish Association of Local Authorities and Regions.