Fast-enrolling clinical trials might seem efficient. Isn’t it a good thing when enrollment can end on time or earlier to keep recruitment costs down and overall trial timelines on track? Unfortunately, fast-enrolling trials can pose several problems.
The challenges of fast enrollment can appear in a variety of therapeutic areas, including oncology, infectious disease, and cardiology, which can show a high prevalence of disease, as well as a large pool of potential participants. In these fast-enrolling trials, it’s critical for sites and sponsors to be equipped with technology that ensures their trials address these challenges. This can result in sites providing more efficient patient care, sponsors meeting diversity goals, the reduction of protocol deviations, and more. See how StudyTeam® for Sites and StudyTeam for Sponsors are designed to address these challenges.
Solution:
StudyTeam for Sites is designed to reduce clinical trial site burden in multiple ways. This platform for managing patient recruitment and enrollment is built with time-saving tools like automatic sponsor updates, visit schedules, and digital checklists to reduce unnecessary manual and administrative work. Site teams can work within digital visit schedules that calculate visit windows with appropriate tolerances per protocol. During patient visits, they can also click through visit-specific checklists that ensure research coordinators complete every necessary step for pre-screening and screening visits. At the same time, sites can easily keep you, the sponsor, updated about enrollment progress without having to de-identify patient information and send emails with log updates. All pre-screening progress in StudyTeam for Sites is automatically visible in StudyTeam for Sponsors in a de-identified format to protect patient privacy.
As for onboarding staff onto StudyTeam for Sites, our online, self-paced training and education portal called the StudyTeam Learning Center (STLC) quickly teaches new StudyTeam users how to work within and benefit from the application. The online portal offers modular content that is easy for site staff to learn and revisit on their own time.
Solution:
With fast-paced patient processing across complex protocols (or amended protocols), it’s not a surprise when visit windows get miscalculated and certain visit tasks are missed. Often, staff also need to manually rework schedules when protocols are amended. The digital visit schedules and pre-programmed visit window calculations in StudyTeam for Sites mentioned above don’t just reduce those administrative elements of site burden, they also protect site teams from protocol deviations.
The digital visit schedules calculate visit windows with accurate tolerances per protocol, even when protocols are amended. This means when site staff go to schedule a patient (or multiple patients) in StudyTeam, the system doesn’t allow them to schedule visits outside of the correct visit window. When the patients arrive for their visits and staff follow the visit-specific checklists that are also built per protocol, they can easily see whether they have completed all of the required tasks before that visit is over.
Solution:
Missed visit tasks and misscheduled visits negatively affect the patient experience when patients have to return for extra follow-ups. It requires extra time and travel. Extra follow-ups also mean extra patient communication for rescheduling, adding to patient burden.
When sites use StudyTeam to schedule visits per protocol, and to confirm they have completed every task necessary during a patient visit, they can avoid those extra follow-ups and points of communication to keep the burden low for patients. At the same time, when staff are less burdened by technology onboarding and manual administrative tasks like de-identifying patient logs and sending enrollment progress updates to sponsors, they have more time to devote to patient care, and to building that human connection that facilitates long-term retention.
Solution:
When trials conclude enrollment quickly and you’re not tracking patient diversity data before randomization, you’re at risk of not enrolling a representative population, even though you may have enrolled plenty of eligible patients. This sets you and your sites up for more work down the road, at times creating a need for postmarketing data collection to confirm the success of your FDA Race and Ethnicity Diversity Plan.
With the right technology, your sites can easily collect clinical trial diversity data during pre-screening, which means you can easily track progress toward enrollment goals while enrollment is ongoing. If you notice certain subsets of patients are not enrolling in your trial, you can identify and address the barriers to their enrollment before it’s too late to include them in your trial.
StudyTeam for Sites makes it easy for site staff to digitally input patient diversity data with other pre-screening information they are logging. Within each digital patient profile the site needs to fill out, “race” and “ethnicity” are simply included as fields to fill out, along with “date of birth,” “sex,” and “research indications,” etc.
StudyTeam for Sponsors aggregates this data for quick and easy analysis on your end. Within the Inclusion and Exclusion Criteria Analysis report, you can see which of your I/E criteria are causing the most pre-screen failures and whether they are disproportionately affecting certain races and ethnicities.
Within the Reasons Declined Analysis Report, you can see the reasons why patients have declined to participate in your trial, and whether there are patterns in reasons declined for certain races and ethnicities. With these insights, you can take fast action during enrollment.
Solution:
Even if enrollment is progressing quickly and relatively successfully for one particular trial, you can still identify patterns in recruitment and enrollment challenges that could be addressed and applied to other trials in your portfolio that aren’t so fast-enrolling. It’s just about having access to the right insights.
In addition to being able to gain visibility into barriers to enrollment for certain patient population subsets and for all candidates based on I/E criteria failures and reasons declined, sponsors can use StudyTeam reporting capabilities to gain insights including:
You can use these recruitment and enrollment insights to optimize your strategy across other trials, from improving your recruitment plans, to proactively addressing sources of patient burden, to proactively updating eligibility criteria.
While fast-enrolling trials ensure patients get access to potential therapies faster and keep overall trial timelines on track, various challenges still come up. Fast enrollment puts your diversity plan at risk if clinical trial diversity data is collected too late. Fast-enrolling trials can be subject to protocol deviations due to hasty procedures and visits. Fast enrollment adds to site burden due to an overload of incoming patient information and visits to manage. This can also lead to less attention allotted to those patients and lower retention rates caused by resulting patient dissatisfaction.
StudyTeam can support sites with tools that are designed to reduce the burdens of manual administrative work and patient visit management while streamlining workflows. And StudyTeam can support you, the sponsor, by aggregating critical, actionable insights while enrollment challenges are playing out. While you support your sites with the right technology, you can also actively make course corrections for your current and future trials.