Endorsements & Opposition
“Genomic data have become important to evaluate efficacy and safety of a drug for regulatory approval. As a result, genomic information has been increasingly included in drug label relevant for the benefit/risk evaluation of a drug. To accumulate such data during drug development and throughout the product life cycle, genomic samples should be collected in clinical trials and other studies following a certain methodology and be stored for certain periods. It has been reported that collection rate of such samples is still low in many ICH regions” … “There is currently no harmonised ICH Guideline on genomic samples collection in clinical trials or other studies. Harmonisation across regions on this topic will maximize the information gathered from the studies for e.g., sample collection and analysis (including ethical considerations) and facilitate implementation of pharmacogenomics for the benefit of all stakeholders. On the contrary, lack of harmonisation could delay such implementation affecting drug development, healthcare delivery with consequent impact on the sponsors, patients and public.”
- At present, there has not been publicly reported opposition to this draft guidance.
Amy Hafez, PhD Candidate & Aubrey Incorvaia, MPP