Colette Thorold

he safe, efficient, and effective execution of a clinical trial relies heavily on site staff completing a large number of tasks. Many of the tasks performed by investigators, study nurses, and pharmacists are required to ensure the trial is compliant to regulations, and in most cases carry the burden of ensuring patient safety. However, these tasks often involve manual, administrative work, which can result in duplicated efforts, such as those involved in completing actions for shipment arrival, patient/subject management, drug dispensation, and drug accountability. To reduce manual tasks and thereby potential risk, clinical trial site staff should embrace technologies – including mobile, sensor, and cloud-based solutions – to improve accuracy of medical dispensation and overall patient safety.

	With the introduction of new and extended regulatory guidelines, it is crucial that clinical trial site staff are equipped with the appropriate technology to help meet those requirements and securely and smoothly manage daily tasks including temperature monitoring, dispensation, and drug accountability.

	While regulations are in place to ensure patient safety throughout the process, there are several procedures involved that can add to existing complexity and time consumption of trial execution. For example, according to research we’ve done at PAREXEL, temperature-monitored drug shipments have increased up to 80 percent over the last two years.

	Beyond the need to help eliminate complexity, another driving force for change and expansion of clinical trial technologies is the user experience. The provision of a technology that drives proactive and productive engagement amongst clinical trial site staff sets the foundation for a successful trial. The quality of a user experience must be considered during design and can be evaluated on several key characteristics, as noted in the chart below.

In developing clinical trial technology, it is essential that the different user groups are understood. Discovering and understanding their daily struggles and addressing these with the appropriate advanced technology will equip these users to more effectively and efficiently run clinical trials. By doing this, it is possible to produce a user experience (UX) that integrates with and supports the daily tasks of the individuals.

	By visiting sites and engaging with site staff, it is possible to gain insight into the user. It is useful to establish a general persona for each user group, highlighting their primary and secondary goals as well as the challenging areas of their role. Identifying the technology product interactions can emphasize which improvements to focus on.

	After initial insight into a user’s experience, it is important to undergo validation of any new concepts. This not only focuses in on any alterations that need to be made, but also engages the user, enabling them to express how they plan to use the new feature/technology.

	To better examine the different use cases and needs of clinical trial technology, it is important to consider each unique user group or role, including clinical site pharmacists and clinical research nurses.

	A pharmacist at a clinical trial site is often responsible for Investigational Medicinal Products (IMPs) for multiple studies at a given time. They must ensure that shipments are processed efficiently and safely; drugs are stored, quarantined, returned, or destroyed according to guidelines; and correct dispensation occurs with accurate dosing – alongside further activities including administrative work.

	Ensuring the safety of patients is the number one priority, and pharmacists must be able to rely on clinical trial technologies to assist them in the management and completion of these extensive and varied responsibilities. A key technology that provides this assistance is Randomization and Trial Supply Management systems (RTSM), including Interactive Response Technology (IRT).

	At large hospital pharmacies, where often over 300 clinical trials can be run concurrently, it is common for the pharmacy to receive a minimum of 10 deliveries each day. Every delivery will require processing to:

		Unpack contents, remove temperature loggers, and paperwork

		Confirm contents match those which are expected

		Complete documentation including accountability log, log arrival in the IRT system, and upload logger data etc.

		Move pack(s) to storage, as per protocol or quarantined

	Every action must be recorded in the IRT system. This heavy workload associated with only one aspect of a pharmacist’s role – the arrival of shipments – limits the time pharmacists have for other vital activities, including allocation and dispensation of drugs to patients. Some pharmacists claim an individual shipment can take up to two hours elapsed time to process, and through our own analysis, have found that they can easily spend 50 percent of their time on shipment arrivals alone.

	A clinical research nurse is responsible for patient care and accurate drug dispensation. They also participate in the returns and reconciliations processes and must maintain clear communication with the site pharmacy to ensure the safety and well-being of patients. Many research nurses see their primary goals as being to “care for the patient and further scientific knowledge through research.”

	Achieving these goals involves many challenges. One concern of nurses is to match the drug with the correct patient. Pack Allocation is a lengthy process, incorporating the following steps:

		Nurse cross-checks patient details with study log

		Pharmacist cross checks pack number with IRT email and completes prescription labels

		Nurse/pharmacist completes study and/or site dependent paper logs

		Nurse collects pack(s) from storage –  checked, labelled, and status updated in IRT

		Nurse cross-checks prescription label against patient details

	Drug is dispensed to the patientAt any stage in this process, the number of people involved increases the opportunity for delays to occur. This can be detrimental to the experiences of clinical trial staff and patients, as well as increases the risk of errors and safety breaches.
	
	


	
	The Internet of Things (IoT) has led to a need to integrate with devices and sensors used by third parties. Alongside IoT, Big Data in the form of dashboards, analytics, and forecasting has given product design a data-driven focus, with the need for such data to be accessible and appealing to users. The UX must be designed for easy interaction and interpretation of the data.
	
	User research has revealed that individuals are increasingly demanding differing ways of interacting with and using the data available to them. Recently, access to IRT technologies has been supplemented with the addition of mobile application to earlier Interactive Voice Response (IVR) and Interactive Web Response (IWR) options.
	
	Using smartphone and sensor technologies 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 process:

With temperature monitoring becoming the norm, it is essential that clinical technology accommodates this. Conventional supply chain monitoring uses temperature loggers that require the shipment to arrive at the site for a temperature alert to be visible. This data is then downloaded from the device by connecting to a USB port, with the output often a PDF. This approach can lead to delays in notification of temperature excursions, investigations and taking action (to either mark as damaged or release medication). These delays have the potential to impact patient safety and trial integrity if medication is not available for a patient visit. Additionally, entering and confirming shipments and packs into the IRT system can be time consuming and error-prone, and is often the secondary step after being noted in the paperwork.

	Applying temperature monitors that transmit near real-time data directly into the IRT system, and providing a mobile application that uses the smartphone camera for barcode scanning can streamline the arrivals process:
	

Barcode scanning and automated temperature data upload and processing both reduces the workload for site staff and improves accuracy and timeliness of data as 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.

What is Next for Clinical Trial Technologies?

	With technology advancing at an exponential rate, it is vital that the clinical trial industry recognizes and utilizes these innovations. These advancing areas include:

 extends visibility and control to end users by displaying real study/program data in a digestible and actionable format. Users are equipped with the information they need to make informed decisions about items such as stock inventory and shipment requests based on patient recruitment/retention, drug expiry dates, and more. Thus, analytics promises to optimize the supply chain by reducing waste of trial materials and patient/staff time and ultimately limiting costs to the sponsor.

 to connect physical devices, smart devices, web software, and other items will ensure that there is the maximum amount of trial data available for both site staff and sponsors. The use of Bluetooth loggers on shipments/packs could enable a smoother arrival process. A simple scan with a mobile device to locate which shipments have arrived, followed by appropriate logging allows site staff to quickly and accurately account for shipments without the need for manual checking.

 to collect patient information could expand the remit of data collection in clinical trials. By remotely monitoring a patient’s vital signs or compliancy to protocol, site staff will have visibility of the patient’s well-being and may even be able to predict or react faster to any adverse events. The compliancy of the patient to the protocol will aid in the understanding of the patient’s happiness and warn of potential withdrawals. This information could also be used by sponsors when designing future studies – considering and choosing the study plan that optimizes patient care and minimizes withdrawal rates.

 must be accessible to the right people, when demanded. Using a secure cloud to connect all smart devices, loggers, mobile applications, and data stores facilitate an “on-the-go” working style. This allows site staff to complete transactions, access data, and gain a near real-time view of their study within seconds.  Smart devices auto-uploading information to the cloud gives study/program managers an accurate portrayal of areas for attention. Eliminating the need for manual upload liberates site staff to spend more time on dispensation and invest further in patient care.

The introduction of direct to patient shipments

 promises to increase the accessibility of drugs for patients, removing mobility constraints and thus broadening the potential recruitment pool. The reduction in site visits could improve a patient’s overall trial experience, which may lead to higher retention rates for the study.

	In order for the benefits of these technologies to be recognized, the UX design must be a primary consideration for the implementation of this new functionality. Users must be able to engage with the product and use it in harmony with their daily tasks.

	If used correctly and developed with the user in mind, clinical technologies can streamline the processes undertaken by site staff on a daily basis. This will ensure a more efficient, effective, and safe clinical trial. The storage of information on an IRT system itself improves the visibility of the actions occurring onsite, and therefore provides a clear audit trail. A collaborative use of mobile technologies alongside near real-time temperature monitoring can give both site staff and sponsors the peace of mind that no drug is being wrongly or dangerously dispensed. All of these benefits eventually result in higher efficiency and, most importantly, improved and assured patient safety.
	
	

		Peter Morville, Semantic Studios, User Experience Honeycomb, 

http://semanticstudios.com/user_experience_design/

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