What is it? Why is it important?

The aim of study feasibly is to evaluate, based on a set of criteria, the likelihood that a study can be conducted, such as:

  • Is target population defined and available?
  • Does the study provide valuable information (e.g. to target group participants, the therapeutic area)?
  • Are selected sites able to conduct the study (e.g. resources, expertise, infrastructure)?
  • Based on study risk category (A, B or C), what are the organisational implications (e.g. documentation of AEs, additional submission to regulatory authorities)?
  • What are expected costs and financial means?

More

Assessment of study feasibility is based on information gathered at:

SP-INV level

Site-INV level – as applicable

  • Required infrastructure (e.g. storage facilities with access control, work space, computers, patient rooms, laboratory facilities, handling of biological material)
  • Resources (e.g. expert physician(s), study nurse or coordinator)
  • Availability of target participants (e.g. sufficient number of patients willing to participate)
  • Sufficient available time needed for study conduct

What do I need to do?

  • Find out how to obtain information on target population in your institution (e.g. number of patients with breast cancer)
  • Be up-to-date on scientific questions pertaining to your study (e.g. scientific publications, expert conferences)
  • Establish and maintain an important network of experts and colleagues
  • Train yourself on setting up a study budget
  • Familiarise yourself with risks as defined by the law

More

When planning a study, many potential risks must be taken into consideration.

In the Swiss law risks are defined based on type of study and its intervention:

  • Studies under ClinO
    • Medicinal products: Category A, B and C with category C having the highest risk
    • Medical Device: Category A and C, with category C having the highest risk
    • Other clinical trials: Category A and B, with category B having the highest risk
  • Decisions regarding target population
    • Adults, children, adolescents
    • Participant with or without capacity
    • Participants in an emergency situation
  • Type of intervention
    • With or without expected direct benefit
    • With or without minimal risks and burdens

Depending on risk category the required risk management can vary greatly.

Where can I get help?

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

References

ICH GCP E6(R2) – see in particular guideline

  • 5.0 Quality management

ISO 14155 – see in particular section

  • Medical Device (access liable to costs)

Swiss Law

HRA – see in particular articles

  • Art.16/24 Adults
  • 22 Children
  • 30/31 Emergency

ClinO – see in particular articles

  • Art. 19–22 Risk categorisation of studies with therapeutic and transplant products
  • Art. 61 Risk categorisation other clinical studies
Abbreviations
  • AE – Adverse Event
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
Concept ↦ Quality and Risk ↦ Study Feasibility ↦ Aim
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Concept ↦ Quality and Risk ↦ Study Feasibility ↦ Aim

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