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Dictionary:

Idea

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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 Agency.

Specific rules for medicines or medical devices

There are specific rules to attend to if your idea includes a medical device.

Specific rules for medical devices

Find out whether your idea includes a medical device

Medical devices include a large number of different products intended for use to indicate, treat or relieve a disease or injury in humans, for example.You can read more about the definition of a medical device in the Swedish Medical Devices Act (SFS 1993:584, in Swedish)external link, opens in new window, on the Swedish Medical Products Agency’s websiteexternal link, opens in new window, and on the page about medical devices.

The intended use is the manufacturer’s description of a product’s area of use and determines whether it shall be defined as a 1 medical device. If you have developed a device, or if you have modified an existing device, it may be that you or the organisation you belong to are the manufacturer, and then it is you yourselves who have to define the intended use and find out whether it is a medical device. You can read more about manufacturer’s liability and how to find out who is the legal manufacturer on the Swedish Medical Products Agency’s websiteexternal link, opens in new window.

If you are proposing to use a commercially available product in your study, you can find out whether it is defined as a medical device by contacting the manufacturer.

Sometimes it is difficult to assess whether the product you are proposing to use is a medical device or not, in particular if the product is to be used in combination with a medicine, for example. If so, please contact a notified bodyexternal link, opens in new window or the Medical Products Agency for advice. The EU Commission also publishes guidelines dealing with delimitation problems.

Guidance document MEDDEV 2.1/3 rev 3
external link, opens in new window
Guidance document MEDDEV 2.14/1 rev 2external link, opens in new window

Is the product ready to be used in a clinical study?

Before the medical device can be used in a clinical study, it shall fulfil the regulatory requirements for safety and performance, as far as is possible without testing it on humans. For example, technical and biological safety tests shall have been conducted and all risks shall have been minimised and balanced against expected clinical benefit. Read more about the regulations’ “significant requirements” below on this page.

Formulate the hypothesis or research question

For the medical device to be used to its best potential in health and medical care, the manufacturer should ensure that the characteristics intended to build up evidence for are also those that the end user is interested in. Claims about the performance of a device must be proved using clinical data, and it can therefore be valuable to discuss questions with key opinion leaders, proposed users, diagnosis groups or representatives of the clinical profession.

The risk management process used during the development of a medical device, together with the clinical evaluation, provide information on the aspects of the products that should be evaluated, and thereby which questions should be answered in a possible clinical study.

The development stage of the product is also of importance to how the hypothesis should be formulated, and whether the study should have an exploratory or confirmatory design, or perhaps both. You can read more about study design and statistical considerations under Planning and Analysis.

Clinical evaluation of the product

A clinical evaluation is one of the activities the manufacturer must carry out to investigate whether the device fulfils the significant requirements for safety and performance.

A detailed method description of how to carry out clinical evaluation is available in the EU Commission’s guideline document MEDDEV 2.7/1external link, opens in new window. In brief, the method consists of collecting data from literature according to specific criteria, and then evaluating them in a systematic way. The evaluation is summarised in a written report, stating whether the device can be shown to fulfil all the requirements using existing data, or whether there are aspects that may need to be tested in new clinical studies.

Which studies need a permit from the Medical Products Agency?

Some clinical studies that involve medical devices shall be notified to and need a permit from the Medical Products Agency. It is important to find out early whether the study requires a permit, as this impacts on many aspects of the continued study planning, including how you formulate your hypothesis or research question. Read more about how to find out whether your study needs a permit from the Medical Products Agency under Planning.

The manufacturer’s documentation for the medical device is needed ahead of notification of a clinical study. If you are not the manufacturer of the product to be used, you should contact the manufacturer to draw up a collaboration that makes it possible to use the product in a clinical study.

Recommendation to follow good clinical practice

The Medical Products Agency recommends that all studies of medical devices that require a permit are conducted according to the European harmonised standard ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical practice. We recommend that you follow ISO 14155 during all stages of a study, from planning to conclusion and archiving. The purpose of ISO 14155 is to:

  • protect the rights, safety and well-being of study participants
  • safeguard scientific implementation and reliable study results
  • define responsibilities
  • function as an aid for the parties involved in the assessment whether medical devices correspond to the significant requirements

All Swedish healthcare personnel have access to standardsexternal link, opens in new window, including ISO 14155 via internet by means of an agreement between SIS publishers and SKL.

Significant requirements and harmonised standards

The requirements set for safety and performance for medical devices are known as the “significant requirements” and are listed in Appendix 1 to the Medical Product Agency’s regulations for the various categories of device (in Swedish)external link, opens in new window (LVFS 2003:11, LVFS 2001:5 and LVFS 2001:7).

To show that the product fulfils the requirements, you can choose to follow the internationally harmonised standards that have been developed in various areas. Harmonised standards have been developed to comply with the requirements in the regulations. Working according to standards is voluntary, but they can be a good help to show that a specific significant requirements in the regulations has been managed in a suitable way. The EU Commission’s website has a list of harmonised standards that may be applicable to medical devices.

Harmonised standard General Medical Devicesexternal link, opens in new window
Harmonised standard Active Implantable Medical Devicesexternal link, opens in new window
Harmonised standard In Vitro Diagnostic Medical Devicesexternal link, opens in new window

Depending on the product studied, different standards may be applicable, and different types of activities may be required before the product can be said to be ready for testing on human subjects. If you need help in the choice of standards to show that the significant requirements have been fulfilled, you can find references to relevant resources you can use via the industry organisation Swedish Medtechexternal link, opens in new window, or MEDEA (in Swedish)external link, opens in new window, for example. Swedish Life Sciences Databaseexternal link, opens in new window has compiled a searchable summary of the various actors within the medical devices area covering both medical device consultants, and also other companies with a medical device profile.