What is a clinical trial?

Definitions

According to the definition of a clinical trial, as described in Regulation (EU) No 536/2014 (the Clinical Trials Regulation, CTR), a clinical trial must first meet the criteria for a clinical study.

Clinical study, according to CTR, means any investigation in relation to humans intended:

• to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products
• to identify any adverse reactions to one or more medicinal products, or
• to study the absorption, distribution, metabolism and excretion of one or more medicinal products

with the objective of ascertaining the safety and/or efficacy of those medicinal products.

Clinical trial means a clinical study which fulfils any of the following conditions:

• the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned
• the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study, or
• diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.

Low-intervention clinical trial means a clinical trial which fulfils all of the following conditions:

• the investigational medicinal products, excluding placebos, are authorised
• according to the protocol of the clinical trial,
  • the investigational medicinal products are used in accordance with the terms of the marketing authorisation, or
  • the use of the investigational medicinal products is evidence‍-‍based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned,

and

• the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned.

A non‍-‍interventional (observational) study is a clinical study other than a clinical trial.

Is authorisation required or not?

The first step is to clarify whether your study is a clinical trial for medicinal products that is subject to authorisation or not. All interventional clinical trials of medicinal products conducted in Sweden must be granted a permit following an assessment by both the Swedish Medical Products Agency (MPA) and the Swedish Ethical Review Authority (Etikprövningsmyndigheten). A non‍-‍interventional study, on the other hand, does not require assessment or authorisation from the Swedish MPA.

Further guidance can be found in the in annex I: “Decision tree to establish a whether a trial is a clinical trial” in the EU Commission document Clinical Trials Regulation (EU) No 536/2014 Questions & Answers.

Prior to conducting a clinical trial

A clinical trial may only be conducted if:

• the expected benefits to the subject or to public health justify the foreseeable risks and disadvantages
• the rights, safety, dignity, and well‍-‍being of the subjects are protected and prioritised over all other interests, such as scientific and public interests
• the subject or their legally designated representative has been informed about the trial, both verbally and in writing, and they have given their written consent
• the trial is designed to produce reliable and robust data.

A clinical trial must undergo a scientific and ethical review before it is authorised to commence.