FUTURE SUPPLY MODELS
right time. Indeed, questions could arise about whether the participant is taking the drug at all, and ensuring that the drug is not given to someone else, Patil says. All of this is hard to monitor without a co-ordinator on hand, he adds.
Where appropriate, adding a nurse home- care element could solve these issues. While oral or topical drugs may seem more ideal for remote drug delivery, intravenous drugs could also be sent directly to the patient, with a visiting nurse assisting with the administration, adds Alexander Pytlarz, president of operations at Infuserve America, an infusion and compounding pharmacy. Nurses can also assist with recording trial data, which can bolster data quality, he notes. Yet, with a nurse visit element, the challenge
is still co-ordination between the patient and the nurse. Has the patient done the required tests before the visit? Has the drug order arrived? Reassuringly, while such issues may lead to rescheduled nurse visits, they do not lead to cancellations, Pytlarz says. Apart from nurse visits, telehealth could also be used where appropriate, Hanna adds.
What about temperature-sensitive drugs? Some investigational drugs are temperature sensitive, and the patient’s home may not be the ideal place for storage, Zobel says. If the drug was shipped to a pharmacy, staff would know how to manage any temperature fluctuations, MacKenzie adds. Oversight of the consistency of
investigational therapies is much more stringent than for approved therapies, Zobel notes. There are limited volumes for investigational drugs, so every dose is important, MacKenzie adds. However, when investigational drugs are shipped to the patient, they are already in temperature-controlled shippers and the patient is advised not to open them until needed, Pytlarz says. The shippers can hold the right temperature for multiple days. If the drug needs to be stored in a refrigerator, it would be
Privacy needs consideration Patient privacy is another consideration with remote drug deliveries. Participant names and
48 | Clinical Trial Supply Handbook
“Questions could arise about whether the participant is taking the drug at all”
addresses should not be accessed by a trial sponsor, Zobel says. There should be clear procedures whereby this information is hidden from sponsors but accessible to the logistics company, she adds. One way of overcoming privacy concerns would be to send the investigational drug to the nurse instead of the patient, Pytlarz suggests. That said, blinding sponsors to patient identities is standard practice in clinical trials, he adds. Trials with such a design would still be subject to privacy regulatory oversight, such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule in the US, Hanna notes.
Tracking drug location is vital In a world where food deliveries can be tracked on a digital map, this technological advance is not yet easily accessible in clinical trials, Zobel says. Tracking is key as it would ensure the investigational drug reaches the patient at the right time, she notes. In clinical trials, the chain of custody needs to be under total control the entire time in order to be compliant with Good Manufacturing Practice, MacKenzie adds. From a pharmacy or a clinical trial site perspective, the challenge is ensuring that every logistics element is in place, Pytlarz says. be done if the details have not been sent through, he adds. At present, communication between people handling investigational drugs is mostly done manually, Zobel notes. Nonetheless, there are short-term goals to
fast-track technology improvements, such as having the functionality of a dispensing order becoming a shipment order, Zobel says. Also, data collection standardisation would help, Hanna adds. This would then lead to data sets that would provide insights on how to bolster remote drug delivery uptake, he explains.
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