In my last blog I discussed how GDP Guidelines were helping to ensure product integrity across the ‘last mile’. Clarification was given on the difference between a ‘last mile’ for commercial products and a ‘last mile’ for clinical trial supplies. The last mile for commercial products is between the Distribution Center and the Pharmacy, whereas in the case of clinical trials, the industry norm is for clinical supplies to be shipped to the investigator site. It is usual that patients visit the investigator site for the administration of the Investigational Medicinal Product. All clinical supplies are monitored up until delivery to the investigator site. However, it is difficult to ensure product integrity up until administration to the patient at the investigator site, as all sites are different. Add to this the sheer volume of clinical trial materials processed by the investigator sites for many different Sponsors.
I was interested to receive your question about what happens with the Direct-To-Patient model, where clinical supplies are delivered directly to a patient’s home. Shipping to the patient’s home is not so much of a problem due to the usual short distance; low cost shippers are already available in the market but how can you even attempt to monitor the integrity of the drug at the patient’s home, i.e. before it is administered. How can you ensure that there is adequate cold chain storage for the drug? Take it a little further…how can you ensure that the right dose is taken by the patient? In terms of ensuring the right intake of the drug, there are RFID solutions in the market for this. However, in order to monitor the cold chain integrity of the IMP, the Sponsor would need to put systems/technology in place to monitor the drug in single doses. Progress is being made on technology to enable this, and I am sure that more solutions will come to the fore as the direct-to-patient model for clinical trials evolves.
For further discussion on direct-to-patient, why not access our blog articles listed below?: