Clinical trial site staff such as investigators, study nurses and pharmacists have a significant burden of tasks to perform to ensure safe, compliant and effective execution of a study. Clinical trial technologies should be designed to reduce or eliminate manual tasks and make repetitive data recording tasks more streamlined, in order to alleviate the administrative work and improve accuracy.
Clinical trial supplies management tasks at sites
One area of site tasks that’s ripe for applying automation to is that of clinical trial supplies management.
There’s a lot of administrative work using multiple forms, files and systems to process shipment arrivals, allocation & dispensing, and returns and reconciliations at clinical trial sites. PAREXEL recently commissioned detailed site visits to view and record these activities, and discovered the following:
- With arrivals, there are often two main stages that can be anything from a few minutes to a number of hours apart. Firstly the initial arrival and unpacking process where loggers (for temperature and other environmental factors) and delivery paperwork are removed, and data is downloaded from the loggers. And the kits are moved to temporary storage. The second stage is processing of the arrivals, involving many steps including checking all kits are present as per delivery note, completing necessary paperwork or spreadsheets, including the accountability log; and logging the arrival in the IRT (Interactive Response Technology, also known as IVR/IWR) system, including upload of any logger data. Finally kits are moved into storage for dispensing or quarantine as appropriate.
- For kit allocations, the task flow can look like this:
- Patient arrival checked and logged
- Prescription (paper) completed and signed by doctor
- Kit allocation made and dispensation started in IRT system
- Kit number written on prescription
- Dispensing – Pharmacy receives email from IRT system
- Study nurse takes prescription to pharmacy
- Cross check patient details with study log
- Cross check kit number with IRT email
- Fill in prescription labels
- Fill in various paper logs
- Collect kit from storage
- Check study ID and kit number against prescription
- Label the kit
- Complete accountability log including any time out of fridge if relevant
- Update subject log.
- Verify kit and confirm dispensation in the IRT system
- Call study nurse to confirm prescription ready for collection.
- And with returns and reconciliations, again there can be significant delays between the time medication is returned and when the accountability processing is done. The study nurse takes returned medication kits to the pharmacy and put into temporary storage for later processing by site staff (pharmacy technician for example). When site staff are available to process returns, the remaining medication is counted / measured and recorded on kit label, in accountability log and in IRT system.
In all of these processes there are lots of opportunities for manually recorded data to be incorrect or inconsistent across paperwork, files and the IRT systems.
How mobile technologies can help
By using smartphone and sensor technologies we can help reduce the administrative burden on site staff associated with managing clinical trial supplies. Taking the task of processing supplies arrivals, we can look at the typical current process:
Conventional supply chain monitoring uses temperature loggers where you need to wait for the shipment to arrive at the site to see there’s a temperature alert, and then download the data from the device by connecting to USB port. The report is often simply a PDF. This approach can lead to delays in being informed about temperature excursions, investigating them and taking action to either mark as damaged or release medication. These delays have the potential to impact patient safety and trial integrity if drug is not available for a patient visit. Also the entering and confirming of shipments and packs (kits) into the IRT (IWR) system can be quite time consuming and error prone, and is often a second step after they’ve already been logged on paper or spreadsheet.
By applying temperature monitors that transmit near real-time data that can be directly fed into the IRT system, and providing a mobile application that uses the smartphone camera for barcode scanning the arrivals process can be streamlined:
Barcode scanning and automated temperature data upload / processing both reduces the workload for site staff and improves accuracy and timeliness of data because it eliminates data transcription. Ultimately the benefit of leveraging these technologies is the improved assurance of knowing that the correct, uncompromised medication was provided to the right patient at the right time.
To learn more watch these two short videos: