Your Easy Guide to Clinical Studies

When planning a study, one of the first steps is to define a sound research question. The question will be the foundation needed to develop a study protocol.

 

A research question should:

• Have a clear focus
• Be of interest to researchers and the public
• Add new knowledge to current problems

 

Assessing the feasibility of a research question can help to decide whether planning a respective study is realistic.

 

An initial evaluation includes the:

• Potential access to adequate numbers of participants from the target population under investigation: a sample-size-calculation estimates the required number of study participants
• Study design best suited to answer the research question. Designs differ greatly in complexity, and have a major impact on the scope of the study. More complex designs require additional resources and finances
• Compliance with principles of research ethics: the study has an acceptable risk-benefit ratio (e.g. participant risks and rights)

As a SP-INV:

• Define your research question based on a systematic review of relevant existing evidence (e.g. literature review)
• Explain why your research question is clinically relevant and worthwhile to investigate
• Define how the research question benefits the population under investigation
• Perform an initial feasibility assessment of your research question

 

In order to answer your research question:

• Define the study hypothesis
• Define study outcome(s)/endpoint(s)
• Define variables (e.g. predictor- and confounding variables) required for the statistical analysis
• Calculate the required sample size, which defines the number of study participants to be included in your study
• Select an appropriate study design
• Consult a statistician for support

 

An often-neglected feasibility aspect is the required time-investment needed to conduct a study. Ensure this aspect is included in your overall feasibility-assessment.

Swiss Law

HRA – see in particular articles

• Art. 5 Scientifically relevant topic
• Art. 10 Scientific requirements
• Art. 11 Protection of participants / Subsidiarity
• Art 12 Protection of participants / Risks and burdens