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
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
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
Swissethics – see in particular
- Templates / Checklists: Study protocol templates
EMA – see in particular
- Non-clinical development
ICH GCP E6(R2) – see in particular section
- 7 Investigator’s brochure
ISO 14155:2020 Medical device (access liable to cost) – see in particular
- Annex B Investigator’s Brochure