Applied Clinical Trials
Kyle Hogan, Director, eClinical Solutions, Clinical Ink, writes how however promising ePRO may be - its benefits may not be enough to overcome concerns that take an significant period of investment before generating business, patient benefits, and financial returns.
Electronic data capture (EDC) has been used in clinical research for more than 20 years - an estimated 90% of sponsors and clinical research organizations (CROs) are currently using some sort of EDC solution.1 Another data collection technology, electronic patient-reported outcome (ePRO) tools, can provide yet more efficiencies to clinical research.
Studies show that ePRO tools yield better quality data and significantly greater subject compliance, sometimes as high as 97%, when compared to paper-based diaries.2 When paired with smartphones and other devices, ePRO data increases convenience for patients, CROs, and sites.
However, CROs adding ePRO to their portfolio today are required to either build solutions from scratch, acquire a company, or work with a partner. In an industry where time is critical, these alternatives are not ideal. Each take an intentional period of investment before generating business, patient benefits, and financial returns.
Thus, however promising ePRO may be, its benefits may not be enough to overcome these concerns - unless this technology is supported long term by appropriate business models.
Beyond legacy ePRO
Many CROs offer ePRO solutions for their trials via some sort of outsourcing agreement. This is a common practice; across the industry, business models support outsourcing multiple services to multiple vendors. This approach, however, does not work in all situations. It can be expensive, create silos, and make adopting newer, more efficient methods difficult.
Furthermore, outsourcing ePRO may mean lost revenue to those CROs that made money from paper-based PRO assessments. For that reason, they may be reluctant to promote an outsourced ePRO option at all to their clients.
An alternative, revenue-producing approach encourages CROs to invest in delivery model innovation. If structured appropriately, this approach can enable CROs to license an ePRO technology, purchase support services à la carte, and create a new revenue stream.
In this manner, CROs would be not only securing an ePRO solution in their service portfolio, but also investing in that solution long term. As Deloitte, a consulting firm with perspective on the effect that shifting business models have on health care, confirms, “Companies that have brought consumption-based offerings to market have been met with considerable success."3
Appropriately, supporting the transfer of ePRO technology requires a consumption-based delivery model where vendors granularly price the services they provide and charge customers according to their use. In the case of ePRO, this can allow CROs to configure a custom combination of ePRO technology and services. And, at the end of the day, it’s the CRO, not the vendor, that holds the control.
Done correctly and with proper technology knowledge transfer and support, this framework builds institutional knowledge and permits ePRO to become a revenue-producing solution for CROs. With control over the ePRO service offering, CROs leverage their existing resources to support and bill for the services they are already familiar with, including project management, help desk, configuration, hardware procurement, inventory management and shipping, and support.
The key to success
Central to the success of this approach is finding a partner that offers a cloud-based, enabling technology and an à la carte enabling process that can set the CRO up to successfully implement, manage, and support an ePRO solution in-house.
In brief, that enabling technology must include:
For a CRO, the goals are to reduce costs, accelerate study startup, develop an additional revenue stream, and maintain complete flexibility and control over ePRO deployment. Therefore, it becomes imperative for the CRO to partner with a vendor with expert knowledge of best practices to sell, configure, and deploy ePRO, and, more importantly, that is willing and able to transfer this knowledge to the CRO.
The CRO takes control - and earns revenue
For the sake of the CRO, the sponsor, and the trial, this transfer of knowledge must be managed carefully. The CRO’s team should be well trained before taking over each task, and communications must leave no room for error: The roles and responsibilities of each team must be clear at all times.
A stepped process is a good way to make this transition, customized according to the CRO’s internal capabilities, capacity, and resources. In this way, the CRO gradually assumes responsibility - from just one aspect of ePRO authoring and deployment to the entire end-to-end process.
For example, the ePRO vendor initially would perform the work while the CRO shadows. Then, the CRO can take on certain tasks as it becomes comfortable and based on its own internal capabilities and resources. This enables the CRO to start earning revenue, which is key. Finally, over time, the well-trained and well-prepared CRO can license the technology and offer ePRO as its own service offering.
ePRO is a technology that can yield significant benefits to the clinical research industry, but if its deployment causes headaches, the technology won’t be widely adopted. CROs would do well to consider a new business model that allows them to maintain control and flexibility while maximizing ROI and ultimately making studies more patient-centric.
1 Veeva. 2018 Unified Clinical Operations Survey. https://www.veeva.com/eu/wp-content/uploads/2019/01/Veeva-2018-Unified-Clinical-Survey-AnnualCROReport-EU.pdf. 2019.
2 Applied Clinical Trials. ePRO vs. Paper. http://www.appliedclinicaltrialsonline.com/epro-vs-paper. 2019.
3 Deloitte. Flexible consumption: Transition to win with pay-per-use business models. https://www2.deloitte.com/us/en/pages/technology-media-and-telecommunications/solutions/pay-per-use-model-flexible-consumption-services.html. 2019.
Kyle Hogan is the Director, eClinical Solutions, Clinical Ink.