What is it? Why is it important?

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)

What do I need to do?

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:

 

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.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

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
Abbreviations
  • CTU – Clinical Trials Unit
  • HRA – Human Research Act
  • SP-INV – Sponsor Investigator
Concept ↦ Protocol ↦ Research Question ↦ Feasibility
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Concept ↦ Protocol ↦ Research Question ↦ Feasibility

Please note: the Easy-GCS tool is currently under construction.