Contributed Commentary By Colin Cleary

November 23, 2015 | Over the past decade, electronic Clinical Outcome Assessment (eCOA) has become increasingly popular in global clinical trials thanks to the technology’s ability to provide more complete data collection, boost compliance, and manage patients in real-time.

Despite its proven record in supporting clinical trials of all sizes and complexities, many sponsors and CROs still have reservations about implementing eCOA strategies because of costs. In an effort to reduce the upfront costs of studies, they may inadvertently limit the number of devices initially provisioned to sites, a mistake that can lead to increased expense and reduce efficiencies later on. One of the practical ways that organizations can better manage the costs of implementing and delivering an eCOA-enabled study is by developing a solid device strategy as early as possible during a trial’s planning process. However, with today's clinical trials growing in complexity, it's no surprise that this is often overlooked during the busy start-up period and as a result, many studies have limited or non-existent eCOA device strategies.

What is a Device Supply Strategy?

A device supply strategy is a mechanism that forecasts the number of devices that will be needed in a study based on assumptions about the protocol and a trial's unique inventory needs, from first to last patient. Its importance is often discounted in the initial minefield of trial start-up activities, even though it has the potential to reduce study costs and logistical headaches further down the line. Without a device supply strategy, there is the possibility that not enough devices will be provisioned for the study, resulting in long-term implications including additional costs for more devices, or device shortages and the resulting logistical complexities associated with managing a trial with limited devices. On the other hand, study teams may overestimate the device inventory needed, adding unnecessary expenditures to their bottom line.

Typically, there are three main components of a supply strategy: forecasting, device allocation and management of resupply inventory.

Forecasting: First, sponsors and CROs will need to look at forecasting the number of eCOA devices needed for a study, and there are many variables that should be taken into consideration when doing this. The number of patients that a sponsor or CRO plans to enroll in the study will serve as a starting point. That said, it is unlikely that this will be the final figure of devices actually needed, due to other influencing factors. For example, if the screening period includes the use of eCOA devices, then the screen failure rate will impact the number of devices needed. Study team will need to allow for the increased number of patients potentially being screened for the trial.

It is also important to consider the recruitment plan for the study. Does the sponsor anticipate linear recruitment or rapid enrollment? If a study is using a linear model, the number of devices in use will increase exponentially over time. However, if the study plans to implement a rapid enrollment process, the device strategy should plan for a higher number of devices during this period. This is because there is likely to be spikes in enrollment, meaning many participants will be using the device at the same time, making the availability of devices for re-use limited.

The number of days a patient will be using the device should also factor into the devices forecasted for a study, as this will impact potential re-use. Finally, in global studies, it is very useful for the sponsor or CRO to supply a breakdown of sites by country to the eCOA provider. While it is straightforward to ship additional devices to a U.S.-based study site should the need arise, a global study involving multiple countries has added complexities, including the logistics of importing devices, as well as the additional time it will take to get devices to the relevant locations.

Device Allocation: Once the initial supply of devices is forecasted, country and site-level device allocation should be considered, in order to ensure the initial deployment goes smoothly. This will limit the chance of over-committing devices and also ensure the devices will be readily available for maintenance. Rather than simply dividing the total number of devices by the number of sites, sponsors and CROs should consider the projected enrollment patterns. First by country, and second, by study site, to identify high and low enrolling possibilities. This information is not always readily available, but the benefits of acquiring it can impact initial allocation quantities and long-term resupply needs.

Management of Resupply Inventory: Often, sponsors and CROs consider only the initial supply of devices needed for a study, and do not think about the trial's long term requirements. To ensure devices are available when needed, sponsors need to manage inventory in line with the recruitment strategy. Then to support with this, the team should actively oversee inventory throughout the duration of the study: Who has the devices? Which sites are performing and recruiting, and which aren’t? Of course, it is crucial for sponsors and CROs to forecast the amount of inventory needed to run the trial, but it is also crucial to proactively manage the inventory already at the study sites and take appropriate steps to retrieve idle devices and supply them to other locations when necessary.

In order to control resupply, sponsors and CROs could limit the initial allocation quantities. This could be done by starting each study site with a lower number of devices than forecasted, and set a resupply level. This tactic leaves valuable inventory available for when sites really need it. They should also define the resupply transaction so that as the study moves forward, an eCOA provider can help control the supply of devices while limiting the approval burden placed on the study team.

Another hurdle which sponsors and CROs may come up against when managing the resupply of inventory with global trials is the complexities of importing devices. Developing nations, as well as the BRIC countries, are continuing to become more prevalent in global trials but can present a challenge when it comes to import logistics and customs. By identifying a central location where devices can be stored, such as a depot or local office, sponsors and CROs can centralize imports, while also minimizing potential shipping delays in complex countries.

Building a Partnership

Sponsors and CROs must develop and maintain a true partnership with their eCOA provider, ensuring they are transparent and share all relevant study information. To help with this, sponsors should designate a team member to work closely with the eCOA provider and spearhead the delivery of the device supply strategy.

Many of the same principles involved in advanced planning for drug supplies and materials for a clinical trial may be applied to forecasting the number of devices required for a study. While each has its own nuances, the premise is the same; both are based on patient forecast models, so it is worth applying a similar approach to each.

Finally, and it may sound obvious, but study teams should make sure that all inventory is collected from study sites and participants once a trial is completed, to allow the eCOA provider to clean the devices and ensure all captured data has been sent to the server.

There are many factors for sponsors and CROs to consider when integrating an eCOA solution within their trial. The device supply strategy is an important part of this process and should not be overlooked. Designing and implementing an appropriate device supply strategy that incorporates proper forecasting, evaluates device allocation and manages inventory resupply, will not only reduce cost in the long run but also support with the complexities of running a modern day global clinical trial.

Colin Cleary is a Program Director at CRF Health responsible for supporting CRF Health's growing portfolio of customers. Prior to moving to the pharmaceutical industry, he oversaw a research program focused on the prevalence and impact of undiagnosed asthma within inner city youth. He can be reached at colin.cleary@crfhealth.com.