As part of its oncology research programme, a Pharmaceutical company has discovered and manufactured a novel chemical entity designed as an antiproliferative agent in gastrointestinal cancers. This entity has been found to be physically and chemically stable and is predicted to be pharmacologically active. As part of the development process the company wants to understand the impact of this compound on DNA integrity. You have been asked to advise on the study type to be undertaken. Would you recommend, a) Phase 3 double blind, randomized controlled clinical trial in cancer patients, refractory to current standard of care b) Cohort study of all patients diagnosed with gastrointestinal cancers over the previous five tears in countries where gastrointestinal cancer incidence is elevated c) Cardiovascular safety pharmacology testing in at least two species of animals, including at least 1 vertebrate species d) Bacterial mutation assay complemented with Ames test using mutant bacterial strains e) Phase 2 clinical trial in patients with gastrointestinal cancer whose DNA has previously been extracted and whole genome sequencing completed f) None of the above
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5647099_1_study-types-assignment-1.pdf
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