A lot can happen in 25 years. In that time, we went from landline internet and bulky personal computers to ever-connected mobile devices. In that same time, nearly all global businesses adopted Microsoft Office for numerous daily tasks. Word, PowerPoint, Outlook, and of course Excel are all part of the suite used by clinical development professionals around the world. But, the use of MS Office hasn’t changed much since for a lot of organizations.
I was a clinical research associate (CRA) back when we used Word Perfect for trip monitoring reports and then eventually Word. These evolved from simple (but inflexible) templates to then have Visual Basic integration, which created process efficiency but even more rigidity in the reporting templates due to the specificity of the back-end reporting. These reports still ended up being printed and given the red ink treatment by managers requesting edit prior to approval.
In parallel, Excel became more widely used to collect key information, such as enrollment data, drug accountability, protocol deviations…you name it! I sat in Excel trainings with CRA and project manager colleagues that were specifically to teach us how to leverage Excel to operate more efficiently in clinical trials. We learned how to apply formulas, charts, graphs, and so on.
Over time, clinical research work became fairly standardized: we used PowerPoint for an investigator meeting presentation, Outlook for email, Word for monitoring reports and authoring of documents and SOPs, and Excel for any reporting. Twenty-ish years ago the term “tracker” came into my awareness as a standard term associated with management and oversight via spreadsheet. Fast forward to 2020 and trackers are still haunting me. When I hear the word tracker it sounds like “TPS Reports” in Office Space.
Like I said, a lot can change in 25 years, but some things don’t change easily. That does not mean people aren’t trying. While usage of Excel trackers has remained stagnant, the rise of clinical trial management system (CTMS) technology offers a centralized approach to collecting, aggregating, and reporting on data from within and across clinical trials. Home-grown and vendor solutions have largely fallen short due to complexity, cumbersome interfaces, and a general lack of user-centric design. In other words, teams are not able to easily see the information they need, when they need it, without jumping through a few too many hoops. This can lead to reverting to our friend the Excel tracker—often even while operating on a CTMS.
We now have a lot of information on what does and does not work, as well as a complete picture of the needs of various users. With this information in hand, a modern approach to CTMS can finally put trackers behind us.
A modern CTMS should focus on:
Being Persona-Driven – CRAs, project managers, project assistants, managers, senior managers, etc., all have different needs. However, they all need to quickly view, enter, and/or export information in order to make rapid decisions within a study or across series of studies or a program. A modern CTMS takes a ground-up approach to optimize these use-cases to the most practical views and processes. A manager needs to see things like views by CRA, visit reports in need of review, and an overview of site activation, whereas a CRA will typically only need to be concerned with their specific sites.
Enabling Data Prioritization – A very big reason CTMS adoption has lagged and teams are generally dissatisfied is that there is way too much data and not enough of that data is relevant, urgent, or important. A modern CTMS collects and presents the most useful data and does not overwhelm the user. We should not ask the user to make too many decisions or to perform data analysis when the system can handle that for them. Configurable dashboards optimized for different users enable them to focus on what is still missing or needs immediate action.
Offering Fewer Clicks – Teams need to complete tasks in one click or as few as possible, and the primary end-goal for sponsors and CRO users is to get to the information quickly and intuitively. A mobile-first approach ensures this becomes reality because of the need for design efficiency to achieve a functional mobile experience. For example, a CRA can access a partially completed trip report or overview a site via an easy filtering process without any logistical obstacles.
Being Mobile-First, not Mobile Friendly – Let’s face it, CRAs are the biggest CTMS user group because they are responsible for entering trip report info, protocol deviations, etc. As time goes on, the average age of the CRA has become younger, and thus more at home on mobile devices (a trend that is only going to continue). Many CRAs who travel frequently prefer to be able to perform their work from the most portable and accessible device rather than having to carry a tablet, flip open a laptop, or wait to get to a location where they can use a PC. More sponsors and CROs are starting to embrace the idea of BYOD (bring your own device) with the proper security and considerations for sensitive information (i.e., in the event of a lost phone). A modern CTMS provides allows you to efficiently complete work on mobile devices in a secure manner. Full stop. It considers the mobile device as the likely access point for these tasks and delivers the utility of a CTMS with the simplicity we all have learned to enjoy in our mobile applications.
Offering Data Visibility – Managers should not struggle with complex reporting to get the information they need. Dashboards that simplify the view are a big part of what makes modern systems valuable for management and oversight. Dashboards are not a new concept, but we now know a lot more about what managers need to see as well as when, why, and how. KPIs such as subject recruitment or protocol deviations provide easy views to see relevant information and act.
Enabling Open API – Your IT team will love you if you pick a platform that makes it easy to connect with other systems such as EDC or IVR. Simply stated, a modern CTMS puts you in control of your information and your infrastructure with painless interoperability across eClinical solutions.
CTMS has to walk a delicate balance, meeting global regulatory requirements while intuitively fitting the day-to-day lives of CRAs and study teams. It bears repeating that many of these team members are on the go and are hindered when their business technology is not at their fingertips. Enhanced mobility affords greater work/life balance due to the ability to operate proactively, and even preemptively. Let’s not ignore the advantages this has for recruiting and talent retention. Making your CRAs happy is a good way to attract talent and a good way to inspire them to stick around for the long journey that a clinical trial entails. Excel’s stickiness isn’t by accident. It is an incredible tool—however, we should not fool ourselves into mistaking it for the right tool, or even an acceptable one. The manual nature of maintaining excel trackers is a compliance nightmare. It’s time to do our part now in being forward thinking with our CTMS technology: start saying no to trackers and yes to mobile-first CTMS!