A. Incorrect. You now have some information that this drug could be associated with particular efficacy in patients with
metastases. Whether this effect is greater than existing therapies is yet to be proven. However, in this patient group the
toxicological effects that have been reported may not necessarily prevent the overall benefit/risk ration from being acceptable.
B. Correct. The original indication for this drug was chronic pain. The toxicology findings would indicate that it is
likely to be unsafe other than when limited to short-term treatment, if it can be given at all. Pain, although very unpleasant
is not life threatening and it is unlikely that given the range of analgesic drugs available, a drug with a risk of pulmonary
fibrosis would be acceptable for the treatment of pain in most patients. The question is one of benefit/risk. Most patients
with disseminated cancer have a limited lifespan, so a risk of pulmonary fibrosis could be acceptable if the drug provides
valuable pain relief in this distressing situation. It is very important to constantly reassess the profile of your drug
during development to ensure that it is being investigated in a way that maximises the benefit while minimising risk to patients.
C. Incorrect. The toxicology findings would indicate that it is likely to be limited to short-term treatment, if it can be given at all.
D. Incorrect. This will need investigation before you commit to clinical studies and it would be premature to switch at this stage without more information.
