Your Easy Guide to Clinical Studies

An intervention is an action or procedure that is carried out and tested. In clinical studies, this could include the:

• Administration of a new drug
• Administration of an approved drug in a new indication (e.g. an approved HIV drug is newly tested to treat rheumatic disease)
• Implementation of a new medical device
• Testing of a new surgical procedure or technology
• Use of a new diagnostic test or tool to detect a particular condition
• Introduction of lifestyle changes (e.g. special diets, workout programs)

 

Apart from the intervention, the SP-INV can decide to include a control group. A control group provides an alternative or reference point to the intervention, such as:

• A placebo group (e.g. a treatment with no active ingredient)
• A standard-of-care treatment group (e.g. existing treatment procedures or an approved drug for a given disease)

 

Comparing the intervention with the control group answers the question whether the intervention was effective and safe.

As a SP-INV:

• Define and assess the feasibility of a study design that includes both an intervention and a control group (e.g. ethical concerns, production costs, accessibility of the target-population, product handling)
• Define the intervention and control group of your study, for example:
  • Intervention group: the administration of the new drug via infusion once a day for 10 days.
  • Control group: the administration of a placebo solution (e.g., a saline solution) via infusion once a day for 10 days.

 

In blinded studies, ensure the placebo, be it a pill, injections, ointment, or some other product, is undistinguishable from the intervention. Aspects to consider include:

• Outer packaging material
• Visual properties (e.g. shape, size, colouring)
• Tactile properties (e.g. density, smoothness, viscosity, feel)
• Smell, colour, and auditory properties

 

The production of a placebo is costly. Ensure to include it in the study budget.

 

Swiss Law

HRA – see in particular

• Art. 13 Placebo

ClinO-MD – see in particular articles

• Art. 2a Definition of clinical intervention
• Art. 2a Definition of performance study

ClinO – see in particular articles

• Art. 2b Definition of intervention
• Art. 2h Definition of placebo

HRO – see in particular article

• Art. 3a Definition of research