While digital tools like electronic clinical outcome assessment had been a growing part of the clinical trial landscape prior to COVID-19 arrival on the scene, they have become increasingly important to researchers, thanks to the obstacles created by the pandemic.
Recently, Outsourcing-Pharma (OSP) spoke with two leaders from IQVIA (IQ)—Kris Gustafson, vice president and global head of Patient Centered Technologies; and JC Wilson, product manager for eCOA—about the increasing use of eCOAs, how the pandemic has impacted their growth, and common misconceptions that could use clearing up about the technology.
OSP: Could you please talk about the rise of eCOAs, and the evolution of the technology, leading up to the pandemic?
IQ: eCOAs were already an essential and fast-growing part of clinical research prior to the pandemic. eCOAs are digital tools that sponsors use to remotely capture patient experience data, giving sponsors the ability to obtain near real-time data and access to study trends; these tools are bringing new data and insights to the research landscape while reducing the data collection burden for patients and site staff.
This is a natural evolution from paper methods to electronic data collection, IVR systems, web based, smart phones, and now to app-based modern eCOAs, such as IQVIA eCOA. With the proliferation of smart phones, this was a natural extension to utilize these devices that are already part of patients’ everyday lives.
Many legacy eCOA systems are built on outdated technology that will be difficult to update to an app-based system and meet the rapidly evolving needs of patients. In a new ISR eCOA/ePRO market report, respondents reported that 68% of studies that collect patient reported outcomes data are conducted using electronic solutions. Over the next two years, respondents expect this ﬁgure to increase to 84% of studies using electronic solutions.
OSP: How did use and acceptance of eCOAs shift and grow after COVID-19 landed on us?
IQ: During the pandemic, when patients either could no longer visit trial sites or simply did not want to due to safety concerns, eCOA quickly became the ‘go to’ measure for collecting patient data in vaccine trials and helped sites maintain compliance through the crisis. Patients spoke loudly about wanting virtual solutions, which forced sponsors to adapt their models quickly.
Traditionally, vaccine trials have relied on paper-based PROs, which are a cumbersome process that prevent sponsors access to any PRO data until weeks or months into the trial. In the current battle against COVID-19, sponsors need to have real-time access to the data to be able to make decisions quickly.
To achieve that real-time access, many current COVID-19 vaccine trials are utilizing eCOA, while also reducing the burden on patients and sites. In fact, IQVIA’s eCOA platform was selected for a number of these trials due to our rapid study start-up, real-time data capture, and cost-effective deployment capabilities.
Going forward, eCOA and other direct-to-patient technology options will only get more sophisticated, bringing a steady stream of useful data to the trial environment. The current generation of mobile phones and commercial devices already make data collection a seamless part of patients’ lives; these benefits were always part of the eCOA value proposition, but for sponsors slow to adopt eCOAs as part of their trial process, their use during the pandemic has been eye-opening.
Now that investigators and sponsors see how easy it is to gather more data, faster, with fewer touchpoints, and less burden to patients, they aren’t likely to give that up. Along with the time and potential cost savings, the permanent adoption of eCOA is a natural evolution in the industry-wide effort to create a more patient-centric clinical trial experience.
OSP: Why do eCOAs make more sense than paper or less streamlined digital methods?
IQ: There are many myths about eCOA use such as higher costs, doesn’t work for patients, and longer development timelines. However, the reality is that eCOAs are an effective tool that can be less expensive than paper, fits into the lifestyle of patients, and can be deployed quickly through libraries with prebuilt assessments.
eCOA dramatically increases compliance, with compliance levels reaching above 95%, compared to less than 10% with paper. eCOA improves data integrity through real-time data flows, timestamped entries, and the ability to integrate multiple data sources. There are also hidden costs of paper such as monitoring and querying data entries, higher recruitment costs due to non-compliance, and regulatory submission risk. eCOAs improve the patient experience and reduce burden, along with enhancing efficiencies for sites and sponsors by reducing manual efforts. Regulators are increasingly promoting and encouraging the use of eCOAs and are willing to include outcomes in product labels.
OSP: Could you please provide detail about the benefits eCOAs offer sites, sponsors, patients (and any other stakeholders I might be missing)?
IQ: Key benefits of eCOA to sponsors, sites, and patients include:
- Delivering almost instant access to patient data, which accelerates sponsors’ ability to identify trends and make decisions.
- Providing a constant flow of data rather than a single snapshot in time, which gives sponsors and investigators a more robust picture of the patient’s condition over time.
- Ability to alert investigators to issues in real-time, lowering the potential impact of some adverse events, and accelerating response for patients in need.
- Bolstering the quality of the data because patients report outcomes as they occur, rather than weeks later at a clinic appointment.
- Eliminating manual data transfer tasks, cutting time and cost from the trial and reducing potential for errors.
OSP: Could you please talk about how eCOAs can help amplify the richness of the patient’s relevant data, such as feelings, physical activity level, and other quality-of-life information? Why is that kind of information important and useful, going beyond “touchy-feely” level data?
IQ: eCOA tools amplify the patient’s relevant information -- such as: how they feel, whether they can participate in physical activity and whether they can return to work and other activities. These tools highlight the quality of life measures and provide sponsors with data about how treatment impacts life quality while maintaining the integrity of trials.
But there’s a misperception about these types of data sets. Some may think that ePROs focus on only asking patients how they are feeling. It’s more than simply quality of life, these endpoints are meant to measure and understand the true experience of a patient using a given treatment. These endpoints dig deeper into the patient experience and provide both qualitative and quantitative data.
The next evolution in eCOA will be figuring out how we can better capture this information and collect more data passively decreasing the burden on patients. For example, instead of asking a patient how they are feeling today, utilize existing functionality within today’s smart phones, such as location, actigraphy, camera, and other metadata, to determine how they are feeling without having to ask. This "ambient data” will be important in the next stages of clinical development.
We need to leverage the technology that’s already in the hands of patients to make it easier to passively gather more comprehensive and accurate data. This will help to better address the quality of life for patients by developing better treatments overall.
OSP: What lessons have trial professionals learned about data collection thanks to the pandemic?
IQ: The pandemic forced sponsors to make dramatic changes to their drug development strategies in order to quickly address the situation and bring safe and effective vaccines to market. Every day there is a delay means that more lives are lost to COVID-19. Historically, this industry is slow to make changes due to the stringent regulatory requirements. The pandemic was a forcing mechanism to make the change to e-clinical solutions occur quickly as there were serious implications for not getting a vaccine out quickly.
These automated tools are bringing a new era of speed, efficiency, and transparency to the drug development landscape, and making it possible to accelerate the development of these critical vaccines. This pandemic is accelerating the transition to more virtual approaches including decentralized trials and eCOA, which will pave the way for new advances in the future and provide more options for patients participating in studies.
OSP: There may be OSP readers who will read your words on our site and think, “Wow, I really need to take his advice and step up my eCOA game.” What advice would you give to someone who’s new to eCOAs on how to best get started and make the best use of the technology in their operation?
IQ: When selecting an eCOA provider to partner with it’s not only important that they have deep expertise, but also the latest technology and experience to support these rapid advancements. Specifically, experience with software and eCOA delivery along with domain experience in successfully running trials. Our IQVIA eCOA team is a dedicated group of industry and technology veterans that can help navigate the complexities of clinical research.
In addition, these data points are becoming increasingly important to regulators as part of the approval process and may impact prescription and adherence trends so it should be a part of drug development strategies moving forward.
OSP: Is there anything else you’d like to tell us about other IQVIA solutions, impact of COVID-19 on the industry, eCOA in general, etc?
IQ: eCOA and other digital health tools were well suited to accommodate the rapid rise in virtual and telehealth shifts due to the pandemic, and there’s no going back. These will continue to be an integral part of the clinical trial environment moving forward – ultimately benefiting all who are involved in bringing new therapies to market from sponsors to individual patients.
With IQVIA eCOA, we’re continually investing in the platform to ensure it best meets the needs of our customers. We have a global library of more than 950 pre-built assessments, giving sponsors instant access to these tools. In addition, we’ve incorporated new artificial Intelligence (AI) capabilities into the platform to transform the design and translations processes.