Director, eClinical Solutions
Electronic data capture (EDC) solutions have been used to collect important information in clinical research for more than 20 years. Today the technology is widely used across the pharmaceutical industry to help reduce development timelines and increase productivity. In fact, EDC has become the method-of-choice for drug and medical device companies and clinical research organizations (CROs) for conducting more efficient, cost-effective clinical trials—so much so, that an estimated 90% of sponsors and clinical research organizations are currently using some sort of EDC solution.
Unsurprisingly, digital solutions provide the same kinds of benefits for patient-reported outcomes as paper solutions. Studies show that electronic patient-reported outcome (ePRO) tools yield better quality data and significantly greater subject compliance, sometimes as high as 97%, when compared to paper-based diaries.
Combining the convenience of EDC with timely data collection using personal computers, tablets, and smartphones, makes deploying ePRO questionnaires both convenient and simple for patients. With these benefits at hand, it comes as no surprise that CROs are looking to improve the patient experience and the quality of the information being collected by implementing ePRO-based solutions more broadly.
Today, CROs adding ePRO to their portfolio are required to either build solutions from scratch, acquire a company, or work with a partner. But these alternatives are not necessarily ideal in an industry where time is of the essence. Each of these options takes an intentional period of investment before it begins generating business, patient benefits, and financial returns. In fact, according to former FDA Commissioner Scott Gottlieb, M.D., “…these opportunities can be delayed or stymied by a clinical research enterprise that is often extraordinarily complex and expensive. Efforts to streamline medical product development … can be frustrated by legacy business models that discourage collaboration and data sharing, and the adoption of disruptive technologies that make clinical research more effective.”
What this means is that the advent of disruptive technology may not be enough to accelerate clinical development, but that to be successful as a long-term solution, these technologies need to also be supported by appropriate business models. Innovative business processes and relationships, for example, can help to streamline medical product development. In the case of ePRO, it’s time to look at a different business model to both accelerate clinical development and make it more patient friendly. This article will discuss a new approach for a cloud-based, mobile, and patient-centric ePRO deployment that flexibly moves control of ePRO to the CRO, allowing it to become revenue generating.
Beyond Legacy ePRO
Today, many CROs offer ePRO solutions for their trials via some sort of outsourcing agreement. This is a common practice across the industry as the majority of pharmaceutical companies’ business models are set up to support outsourcing multiple service functions 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.
The solution for companies looking to move away from using today’s ePRO solutions to a better, faster, revenue-producing approach is to invest in delivery model innovation. For example, the newest, cloudbased approaches make ePRO implementation both easy and lucrative for CROs. With complete control over deployment, delivery, and support of the system, implementing and sustaining these approaches is significantly different than previously adopted approaches.
Making a deliberate business investment in this approach gives CROs an opportunity that other organizations do not have: to license an easy-to-configure ePRO technology, purchase support services à la carte, and jump right into creating a new revenue stream. They are choosing not only to secure an ePRO solution in their portfolio of clinical development services, but also to invest in supporting that solution long term. 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.”
Appropriately, making the move to support ePRO transfer technology requires a consumption-based delivery model where vendors granularly price the services that they provide and charge customers according to their use. In the case of ePRO, this allows CROs to configure a custom combination of ePRO technology and services that get the job done efficiently and cost-effectively. At the end of the day, it’s the CRO that chooses to take control of the process—to configure and build a solution that meets their specific needs for an ePRO or eCOA solution in any therapeutic area.
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 are able to leverage their existing infrastructure and resources to support the solution with, and thus bill for, 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 both a cloud-based, enabling technology and an à la carte enabling process that—based on the individual capabilities, capacity, and skills resident in the CRO—can set the CRO up to successfully implement, manage, and support an ePRO solution in house.
What to look for in an enabling technology
A configurable interface
Look for a vendor that offers a configurable platform interface, specifically, an authoring tool that enables self-service ePRO design, testing, and implementation. When reviewing the technology, be sure the interface:
- Is easy to use and does not require specialized programming skills
- Has simple drag-and-drop capabilities, selection wizards, and versioning control
- Adapts to a range of copyright needs including, for example:
- Response-based branching
- Image placement
- Robust questionnaire controls including:
- Numerical rating scale
- Visual analog scale
- Yes/no
- Multiple choice
- Scoring and coding
Full-bodied ePRO functionality
There are several aspects to consider from a functionality standpoint. The most important is to ensure the system you choose meets FDA standards. At minimum, the ePRO technology system should follow 21CFR Part 11 and ALCOA, which according to the FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, means that, “Source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA).”
Other functionality considerations include:
- A user-friendly, intuitive patient interface that is compatible across multiple devices and platforms including Apple and Android smartphone devices with flexibility for bring your own device, provisioned, and mixed-mode solutions.
- Automatic triggering and delivery of alerts and reminders for engagement and compliance.
- An in-app training module for patients to ease site burden.
- A robust question library that includes a pool of questions andpreconfigured measurement instruments with easy creation, import, and lock (version controlling) of questionnaires.
Support
One of the most expensive components of launching and maintaining an ePRO service offering is its support. To ensure your success, be sure the vendor you choose provides a support system that off ers adequate consultation, help desk support, and training that includes:
- Customizable options to align with roles and responsibilities of the organization including how to:
- Translate a protocol and develop a study
- Use the authoring tool and application
- Provision devices
- Manage instrument copyright licensing
- Sell the ePRO tool and services
- Real study simulations that use real study data to ensure understanding and process
- Access to a sandbox in which the CRO can build a study, publish, and deploy to a test device
- Flexible learning formats including webinars and live classroom training at the CRO’s site or vendor site
- Training certifications and other tools to support best practices including checklists and templates
The Road to ePRO Self-Sufficiency
The benefits of a technology enablement are to reduce costs, accelerate study startup, enable the CRO to develop additional revenue streams from its new ePRO capabilities, and provide complete flexibility and control over ePRO deployment. With expert knowledge of best practices to sell, confi gure, and deploy ePRO, the ePRO vendor can transfer this knowledge to CROs so that they may become profi cient in any or all steps of successful deployment.
The three-stage process to transition ePRO can be contracted on a study-by-study basis and customized according to the CRO’s internal capabilities, capacity, and resources. The ePRO vendor should work with the CRO to scope appropriate support levels dependent upon the CRO’s preferences. CROs can take on as much of the process as feasible—from just one aspect of ePRO authoring and deployment to the entire end-to-end process.
Stage 1
In stage 1 of the process, the ePRO vendor’s role is similar to that within a partnership model where it provides all confi guration, coordination, and execution of the implementation process. In this model, the vendor is also beginning to train the CRO client how to do it themselves.
The approach is completely à la carte, allowing the ePRO vendor to design training programs that align with the activities that the CRO will eventually assume. The CRO’s capacity and skill sets are taken into consideration so that the right fit of functions can be determined. The roles, responsibilities, and functions are defined so that any service the CRO does not want to take on will continue to be provided by the ePRO vendor. The stage can be repeated as necessary to ensure knowledge transfer has been successful and the CRO is comfortable to transition to the next stage.
Stage 2
In stage 2 of the process, the CRO begins to execute some—or all—of the process. The CRO only needs to take on as much as it is comfortable with. And, as was the case in stage 1, the CRO and ePRO vendor can choose to extend this stage into multiple studies, or iterations, until the CRO is ready to take on a more active role.
With the ePRO vendor’s support and oversight, the CRO takes on the functions it believes it can manage. For example, the ePRO vendor could retain aspects of project management or device procurement or assist with aspects of user acceptance testing.
Most importantly, at this stage, the CRO can begin to earn revenue for its deployment of the ePRO system. In many cases, the more functions the CRO chooses to take on, the more revenue it can bring in. It should also be noted that if the CRO is not interested in supporting the process, vendors should offer varying solutions for partnership work supporting alternative means for profit sharing.
Stage 3
In stage 3, the CRO is well prepared to take on all the activities outlined in its ePRO strategy. Here it will begin to license the ePRO technology from the vendor; its monetary return will be proportionate to the amount of the process it is supporting.
Conclusion
The wide adoption of EDC has brought CROs the ability to quickly and efficiently shift and adapt to changing requirements in the pharmaceutical industry. And, with the advent of new technologies and integrations, CROs hoping to maximize the value in the data from patient feedback are turning to tech transferrable ePRO methods that are simple, reproducible, and scalable.
Nevertheless, these new technologies need a new business model to work—an approach that not only gives them the control and flexibility they need to jump right into building and conducting more patientcentric studies, but also the tools they need to maximize their ROI and bring more treatments to more patients faster.
References
- 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.
- Applied Clinical Trials. ePRO vs. Paper. http://www.appliedclinicaltrialsonline.com/epro-vspaper. 2019.
- FDA. Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633500.htm. 2019.
- 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.
- FDA. Electronic Source Data in Clinical Investigations. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf. 2019.
Author Biography
Kyle Hogan is responsible for the strategic alignment of the company’s native mobile application for ePRO/eCOA and patient engagement in clinical trials. He has delivered technical solutions for complex business challenges since the 1990s and has 15 years of experience in clinical trials. Kyle has managed numerous, global ePRO trial deployments and has been instrumental in the development of Clinical Ink’s mobile solutions for patient-centric ePRO/eCOA. A recognized industry expert in this area, he regularly helps sponsors realize BYOD-capable solutions for clinical trial data collection.