There has been a shift in the way that quality-of-life studies are conducted within the life sciences industry. Traditionally, such studies would involve the collection of data – through, for instance, questionnaires or interviews – over the course of a few months before an assessment of the data at the conclusion of the collection period. This would essentially mean that the entire research project could remain a closed box until the end. In previous roles outside of Vitaccess, we have experienced a project that took six months for the data to be unlocked, only to discover that virtually no useable data had actually been generated. This scenario can result in dropping entire value stories from dossiers or HTA strategies, or scrambling for something that would be good enough, with a significantly weakened value proposition.
We work differently at Vitaccess. From the first week of a study we conduct ongoing analytics that monitor recruitment and engagement: how quickly participants are joining the study and across which baseline personal, disease, or treatment characteristics, and then the extent to which participants are completing questions in the study. This includes, over time, whether attrition or fatigue is setting in.
The reason that we can go to these lengths is that Vitaccess Real™ is a digital real-world evidence platform. Gathering data digitally, through smartphones, websites, and more, enables our Analytics team to review data in near-real time. Pairing that with engagement analysis means that the scenario in which data are found to be flawed well after-the-fact cannot happen in our studies. In fact, we can identify any issues within days and often implement pre-specified contingencies within a week, resulting in very little loss of data.
Engagement analysis is also an important tool for our clients to report internally on progress and study performance by tracking enrollment and engagement: examining, for example, how many participants did we recruit? How many participants began filling out a particular questionnaire, and did these participants get to the end or stop halfway through? Did a particular questionnaire take too little or too much time to complete?
The real advantage of conducting a quality-of-life study digitally is that participants can access the study through their own device, or a website, when it is convenient for them. Resources are not restricted in the same way as in clinical or other studies, with the result that recruitment can run longer and we can include more PROs and bespoke questions. That has to come with finding a balance between ambition and time, specifically the burden on participants – routine engagement analysis means that we can find and maintain that balance consistently throughout a study.
All of our analyses are conducted in-house thanks to a team comprised of experts in econometrics, statistics, data science, and data visualization – meaning that our work is presented on near-real-time dashboards to clients. Since all of the required functions are integrated within the business, any client queries or concerns are typically dealt with within a day or two.
With the combination of Vitaccess Real and our in-house capabilities, our clients see rich data to which they have never had access before, in studies that we have de-risked from one of the greatest concerns: producing nothing. Participant enrollment is maximized, data volume is maximized, and there are no nasty surprises waiting at the end of the road.
If you are interested in working with us to develop a robust and impactful digital real-world study, get in touch here.
By Fatemeh Amini & Casey Quinn