What is it? Why is it important?
The study design is the overall strategy used to integrate all different study components needed to answer a study question.
Many study designs exist but most can be divided into:
- Exploratory research designs: used to investigate a problem that is not clearly defined
- Observational research designs: observe and describe a situation without influencing its outcome
- Causal research designs: evaluate the impact of a specific change on existing norms and assumptions
The aim and complexity of a study can affect the choice of study design that must be implemented. The use of a study design does again significantly affect:
What do I need to do?
- Avoid unnecessary complexity and procedures
- Ensure study documents are clear, concise, and consistent
- Ensure that collected data, whether based on an electronic- or paper CRF reflect specifications given in the study protocol
- Select the minimum of required variables to answer your study question
Only variables contributing to the answer of your study question will be useful. Collection based on "nice to have" rather than data needed to answer the study question will only increase study complexity and resources, and finally the study budget.
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
ICH GCP E6(R2) – see in particular guideline
- 5.4 Trial design
ICH Topic E9 Statistical principles for clinical trials - see in particular guideline
- 3 Trial design consideration
ICH Topic E8 (R1) General considerations for clinical studies – see in particular guideline
- 2.2 Scientific approach in design and analysis
ISO 14155:2020 Medical devices (access liable to costs) - see in particular section
- 6.3 Justification for the design