en
Dictionary:

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 SBU External 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 care External 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 knowledge External 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.se External 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 Authority.

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

New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021.

Find out whether your idea includes a medical device

If you are planning for a medical technical clinical trial on as part of the product development prior to CE marking, you probably already know whether the product in your study is defined as a medical technology product or not. However, this is not always as obvious in studies initiated by academia or by healthcare.

Medical devices include a large number of different products which in summary can be described as different technical solutions intended for use on humans for a medical purpose. You can read about the complete definition of a medical device in the EU regulation on medical devices, on the Swedish Medical Products Agencys´s website there is also information about definitions.

The so-called intended purpose is the manufacturer’s description of a product’s area of use and determines whether it shall be defined as amedical device. If you intend to study a product that you have designed yourself, if you want to use a product for medical purposes that was not originally intended for it, or if you have modified an existing medical device, it may be that you or the organisation you belong to are the manufacturer. In these cases it is you yourselves who are responsible for finding out whether the medical product fulfills the definition for a medical device and thus must also follow the special rules that apply to clinical trials on medical devices.

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. If so, please contact the Swedish Medical Products Agency for advice. The EU Commission also publishes guidelines dealing with delimitation problems around, for example, medical technology software.

The definition of a medical device in the EU regulation External link.

Information about definitions, the Swedish Medical Product Agengy´s website External link.

Guidance on medical technology software: MDCG 2019-11, The European Commission's website External link.

Is the product ready for use in a clinical investigation of medical devices?

Before the medical device can be used in a clinical investigation of medical devices , it shall fulfil the regulatory, so-called general, 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’ general requirements below on this page.

Clinical evaluation of the product

A manufacturer planning to perform clinical investigation of medical devices prior to CE marking of their product must first perform a clinical evaluation.

A method description of how to carry out clinical evaluation is available in the EU regulation on medical devices, appendix XIV. 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 general requirements on safety and performance using existing data, or whether there are aspects that may need to be tested in new medical technical clinical studies.

Method description for how clinical evaluation should take place, EU regulation on medical devices, Appendix XIV External link.

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 safety and 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 results from 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 investigation of medical devices.

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 on the pages Planning and Analysis on this website.

Guidance - Clinical Evidence for Medical Software: MDCG 2020-1: European Commission website External link.

Information about study design on the page Planning External link.

Information about statistical considerations on the page Analysis External link.

All clinical investigation of medical devices require permission from the Swedish Medical Products Agency

All clinical investigation of medical devices shall be notified to the Swedish Medical Products Agency and some also needs a permit from the same authority. Read more about notifications and permits from the Swedish Medical Products Agency on the page Planning or on the Swedish Medical Product Agency´s website.

Plan your study, information on registration or permit required

Notification and permission,The Medical Products Agency's website External link.

Recommendation to follow good clinical practice

The Swedish Medical Products Agency recommends that all medical technical clinical trials are conducted according to the European standard ISO 14155:2020, Clinical investigation of medical devices for human subjects – Good clinical practice. The purpose of ISO 14155:2020 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 general requirements on safety and performance

All Swedish healthcare personnel have access to standards, including ISO 14155:2020 via internet by means of an agreement between Swedish Standards Institute (SIS) publishers and SKR.

Standards on SIS website (login required) External link.

General requirements and harmonised standards

The requirements set for safety and performance for medical devices are known as the “general requirements” and are listed in Appendix I to EU regulation on medical devices.

Medical devices, requirements and safety - Annex I, EU Regulation External link.

To show that the product fulfils the requirements, you can choose to follow the internationally 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 conformity with a specific requirement in the regulation. Work is underway to harmonize standards with the EU regulation on medical devices. For the time being, you can use the standards that have been harmonized with the previous directives and that have been published on the EU Commission’s website.

Harmonised standard General Medical Devices External link.

Harmonised standard Active Implantable Medical Devices External link.

When it comes to medical devices for in-vitro diagnostic there is still standards who are harmonised with the current EU directive:

Harmonised standard In Vitro Diagnostic Medical Devices External link.

Depending on the product studied, different standards may be applicable, and different investigations of the product may need to be done before the general requirements on safety and performance can be said to be met as far as possible without testing the product on humans. Only then is it ready for use in a medical technical clinical trial.

If you need help in the choice of suitable standards to use, you can find references to relevant resources you can use via the industry organisation Swedish Medtech, or MEDEA, for example. Swedish Life Sciences Database 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.

Swedish Medtech External link.

MEDEA (in Swedish) External link.

Swedish Life Sciences Database External link.