Because oncology drug development usually entails several indications being studied in parallel, a parallel study may look at a different indication in biomarker-positive patients only, to optimize the chance of PoC for the drug.
It was noted that communication across disciplines (e.g. clinical, CMC, toxicology) is key to ensure appropriate controls are in place, especially since dose levels may change or the drug may be used in combination with others or for a different indication.
Given that clofazimine is already used in the clinic, albeit for a completely different indication, we wondered whether it is efficacious in animal models of organ transplantation.
A multi-center cross-sectional study with a survey of 272 employees was conducted in fifteen rehabilitation clinics with different indication fields in Germany.
In spite of their different indication we did not distinguish between antiplatelet and anticoagulant agents as basic evidence-based medication.
A cohort of tumor indications is selected for the first wave investigation and the second wave investigation in a different cohort of tumor indications is initiated only after the drug has been demonstrated to be effective in the first wave.
One of the six drugs (imatinib) was associated with five different predictive biomarkers in five different indications (figure 4).
Rituximab was used in 22 different indications, botulinum toxin in 5 and omalizumab in 5 (more information on therapeutic subgroups and medicines is available in the annex 1 of the supplementary material).
These agents have been used in human for different indications, the former as a phase I anticancer agent and the latter as an established antiepileptic drug that was recently demonstrated to have anticancer activity in vitro and in vivo animal model (Gottlicher et al, 2001).
A descriptive analysis of the distributions of antimicrobial use in different indications was performed.
