What is it? Why is it important?

The aim of pre-clinical studies is to collect efficacy and safety data. These studies are mandatory, as they evaluate whether a potential Investigational Medicinal Product (IMP) or Investigational Medical Device (IMD) can be tested in human studies.

Pre-clinical IMP studies assess:

  • The pharmacological effect of the IMP (e.g. physiological and/or biomedical changes)
  • The potential toxicity of the IMP or its potential to cause harm (e.g. acute and repeated dose -, reproductive-, Geno-toxicity, carcinogenicity)
  • A safe starting dose to be implemented in first-in-human studies

Pre-clinical MDs studies assess:

  • The safety and biocompatibility of the IMD or its components
  • Any risk of illness or injury caused by the IMD

More

In vitro preclinical studies are studies performed outside a living organism, such as research with microorganisms, cells, tissue extracts, or dead organisms.

In vivo preclinical studies are studies done with or within an entire living organism, such as animal studies.

What do I need to do?

Safety data from pre-clinical studies are documented in the Investigator’s Brochure (IB), consequently:

  • As a SP-INV manufacturing a new IMP or IMD:
    • Plan, perform, and monitor pre-clinical studies, and record, report and archive data
    • Collect all currently available data obtained from pre-clinical studies and write the preclinical part of the IB
  • As a SP-INV or Site-INV involved in studies with an IMP or IMD manufactured by a company:
    • Consult the IB written by the manufacturer to become aware of pre-clinical results (e.g. results provide important information for the safety planning of your study)

Where can I get help?

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

External Links

https://www.sctoplatforms.ch/en/tools/safety-matrix-finding-the-right-expert-58.html

Swissethics – see in particular

  • Templates and Checklists: Study protocol templates

References

ICH GCP E6(R2) – see in particular section and annex

  • 7 Investigator’s brochure

ISO 14155:2020 Medical device (access liable to cost) – see in particular

  • Annex B Investigator’s Brochure
Abbreviations
  • CTU – Clinical Trials Unit
  • IB – Investigator`s Brochure
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP– Investigational Medicinal Product
  • IMD - Investigational Medical Device
  • ISO – International Organization for Standardization
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Basic ↦ Safety ↦ Safety Data ↦ Pre-Clinial Studies
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): Basic ↦ Safety ↦ Safety Data ↦ Pre-Clinial Studies

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