What is it? Why is it important?
An Interim Analysis (IA) is done before all data collection is complete, so as to evaluate the safetyProtocol and efficacy of the study while the study is still ongoing.
An IA is recommended when:
- A treatment is expected to be particularly beneficial or harmful compared to placebo
- Based on ethical considerations, treatment differences must be assessed in order to decide early on whether to continue, adapt or terminate the study
- A study is planned to last for many years
An IA must be planned prior to study implementation or be approved through an amendment. Timing and rational of IAs must be defined in the study protocol.
What do I need to do?
Perform the IA as defined by the study protocol, which might include:
- The timing of IA (e.g. after the inclusion of x amounts of participants, after visit x)
- Statistical methods used
- Guidelines for the interpretation of results (e.g. upper- lower tolerability defining study continuation, adaptations, or study stop)
- The decision whether to continue, adapt, or terminate the study
- If requested by EC/RA submit an applicable IA report
For more information refer to Statistics in this Study Guide.
If the study must be terminated, follow protocol procedures and initiate study closure.
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 guidelines
- 5.4.1 Interim report
- 6.9.1 Statistics, interim analysis