In our recent webinar, DCTs: How to get investigational drugs to patients, Susan Rizzo, Director, Service Delivery RTSM, Bioclinica Software Solutions, discussed the challenges with the distribution, tracking, reconciliation and destruction of investigational medicinal products (IMP) during decentralized clinical trials (DCTs). This is top of mind for many companies as they shifted to virtual and remote trials during the pandemic.
To hear the full discussion, view the on-demand webinar. Here, we present the questions from the audience, along with Susan’s answers.
Q1. Is it feasible to use all the delivery types in a clinical trial to have more options for patients? Can an IRT system handle multiple options or is it advisable to pick one type per trial?
A1. It really depends on the system you’re using. The IRT team would have to know those choices upfront so that the system could be designed to accommodate those options. Ideally, two delivery types would be the maximum, as it would become challenging for an IRT system to handle more than that.
Q2. One mode I don’t hear often discussed is that the location of patient visits can be a choice between patient and investigator on a visit-by-visit basis, which requires a level of interaction with the IRT for site personnel that IRT systems don’t normally provide (i.e., scheduling visits in advance). Has this been considered?
A2. That is something that should be considered for an IRT system. Although the Bioclinica IRT doesn’t have this capability yet, this would be similar to the functionality I discussed in the presentation where you would be able to switch between a traditional study design and a decentralized design. There would need to be a way to go back and forth between the two.
Q3. What considerations are needed for patient confidentiality when name/address needs to be provided to courier?
A3. The rule of thumb here is to limit sharing the patient identifiers with only those who need it. For an IRT system, the patient details (name, address) should be encrypted so that it would only be seen by the distribution depot on shipment requests.
Q4. Are there methods to make sure that the patient is the person who received the drugs?
A4. Ideally, the site would be in close contact with the patient to make sure it got to the right person. Otherwise, there could be a requirement to have the signatory on the shipment when it’s received at the patient’s home. If not, the IRT team might need to make sure that the process is handled for that drug.
Q5. Are there certain types of drugs that are more suited to each of the delivery types, for example, by a local pharmacy, shipped direct or hand delivery?
A5. Although this question is probably best suited for the team handling drug supply, from an IRT perspective, the system can handle any type of a shipment to a patient’s home. More care would need to be given for drugs that need to be temperature controlled. There are a lot of unknowns: will the drug be refrigerated as soon as it arrives? Will someone be at home when it’s delivered?
Q6. What are your thoughts about temperature tracking from site to patient in the IRT?
A6. There are obvious logistical concerns regarding these types of shipments. From an operational perspective, there should be a determination regarding the ability to have the patient read a temperature tracking device. Considerations such as the target patient population in the protocol would be key for determining if this was a feasible scenario. Some study teams have suggested using video calls with the patient to assist them with reading the device; so, it is possible. Regardless, there would need to be a way to have temperature excursions registered in the IRT, as would be done in any other study.
Q7. Who is responsible for the chain of custody of the IMP, and what role does the IRT system play?
A7. The chain of custody should be defined by your standard operating procedures (SOPs). That will dictate how you go about determining who has the responsibility for the chain of custody. You also may need to put some training in place for couriers or pharmacies. You should choose an IRT system that provides appropriate audit trails and the capability to track that IMP throughout its entire lifecycle. By that, I mean, the IMP going from the depot to the site, perhaps to the patient, then back to the site, as well as accountability and reconciliation at the end of the study.
Q8. Is this more on US sites? Do you have experience with EU, APAC, ROW sites?
A8. The need for direct-to-patient trials exists worldwide. As stated in the webinar, there would need to be a determinization of which types of trials work best for the situation. In addition, local laws need to be considered when shipping drug to patient homes.
Contact us to learn more about how Bioclinica IRT can support your studies.