The healthcare industry has been working around-the-clock to swiftly respond to the COVID-19 pandemic. It has become clear that the most essential weapon against COVID-19 – and getting things back to ‘normal’ – will be a safe and effective vaccine.

It usually takes years to develop and test new vaccine candidates. However, recent advances in scientific research, data collection, and analytics tools are making it possible for developers to shear months off this process without compromising the integrity of the study and data. These tools include the use of electronic Clinical Outcomes Assessments (eCOAs), which can be rapidly implemented to capture patient reported outcomes (PROs), giving sponsors almost instant access to study trends.

The problem with paper

Traditionally, vaccine trials have relied on paper-based PROs. Study participants are provided diary sheets to manually fill out, documenting their health experiences after being inoculated. They will then return those paper diaries at their next doctor’s visit, typically weeks after they are vaccinated.

The site staff collects the diaries, and at predefined intervals, they send them back to the sponsors to be manually transcribed into a trial database. It’s a cumbersome process that means sponsors don’t gain access to any PRO data until weeks or months into the trial. 

In the current battle against COVID-19, sponsors don’t have months to wait. They need to know immediately whether their vaccine is working as anticipated.

Therefore, many current COVID-19 vaccine trials are utilizing eCOA to accelerate the data collection process, 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 and real-time data capture capabilities. 

Data on Day One

IQVIA’s eCOA platform makes it possible for sponsors to select or develop a custom eCOA in real-time to enhance the patient experience while improving data quality. The platform offers a global library of more than 800 pre-built assessments, giving sponsors instant access to purpose-built tools ready to capture the patient’s perspective in any given study. 

If the library doesn’t have the right assessment, our developers can build one on-the-fly in direct collaboration with the sponsor, ensuring the final product fits their exact specifications. Through this iterative process, the sponsor sees and approves the instrument design, usually within 24-48 hours. Then the final assessment is generated, validated, tested, and ready for use in as little as 2 weeks if needed -- compared to the 12-16 weeks that is the standard industry average for other eCOA vendors.

In the current pandemic, this rapid turnaround made it possible for sponsors to cut up to three months from their eCOA development timeline. This ensured they achieved their first-patient-in timelines for these massive global trials and provided them instant access to data directly from patients. 

As soon as participants join one of these trials, and they are given access to the eCOA diary – via their own devices, or a provisioned device provided by the sponsor – they can begin recording their experiences immediately, which ensures protocol compliance and provides more accurate data collection. All of the data they enter directly flows to the research team in real-time.

Millions of data points

The speed with which study teams can review PROs using the IQVIA eCOA platform is dramatic. In one vaccine trial currently underway, by the end of day one, the eCOA already recorded over 100 entries, giving the study team instant information about the participants’ compliance and experiences with the vaccine. 

Sponsors can also use automated analytics tools to monitor the data as it flows in, to quickly identify important trends related to compliance. Automated analysis is critical in vaccine trials, which often have tens of thousands of participants and millions of pieces of data to analyze.

The instant access and analysis mean sponsors can more rapidly assess the vaccines safety and efficacy, and promptly respond to any potential adverse events that arise. In comparison, using a paper-based PRO approach, they may not capture those events until weeks after they occurred.  

Along with faster access to data, eCOAs also provide more controlled results. For example, if an eCOA requires daily reports, participants can only record information about a single day during those 24-hours. If they skip a day, they are unable to go back. This prevents participants from filling in all the diary pages at the last minute and trying to remember what occurred on those days – known as the ‘parking lot’ effect. Overall, this will reduce the study participants’ burden by eliminating the need for multiple office visits and increase the quality of the data. 

Because the data is recorded electronically, there is also a lower risk of data getting lost in the transcription process or thrown out due to illegible handwriting. The eCOA systems can also send alerts reminding participants to complete PRO activities, and signal study teams when participants may fall behind. 

The future of remote data collection in clinical research

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. 

By shortening the time to create an eCOA and providing instant access to patient data, these electronic tools are making it possible for sponsors to gain faster, more reliable insights to prove the safety and efficacy of new treatments. 

That value proposition is useful for any drug development project, but in the case of COVID-19, it is essential. The sooner we can develop vaccines and prove their safety and effectiveness, the sooner we can end this pandemic and get the world back to normal again.

IQVIA is proud to be a part of this journey. Within the IQVIA eCOA team, our goal is to ensure each patient is at the center of care and we give them a voice to share their story. To speak with an expert to learn more about how eCOA can transform your study, email us at ecoa@iqvia.com.