Business, Technology, Internet and network concept. select on the virtual display: Clinical trial
Clinical trials and long-term follow-up studies (LTFUs) hinge on a whirlwind of data collection, where the volume and quality of patient data form the cornerstone of success. Erratic and patchy data can throw a monkey wrench into evaluating the potency and safety of cutting-edge drugs and devices. Such snags can drag approvals through the mud or have regulatory bodies such as the Food and Drug Administration (FDA) clamoring for more clinical evidence.
Thus, a complete patient data set is invaluable to trial sponsors. However, tracking patients for a long-term follow-up study presents more challenges regarding data collection.
Clinical studies can be demanding during baseline screening and the treatment period. Patients may have regular weekly or monthly tasks they’re asked to complete while staying in contact with trial staff on a fixed basis, attending scheduled appointments, completing surveys, and sometimes keeping daily diaries. All of this takes place over a shorter span of time, where patients are constantly engaged and continuously prompted to continue moving through to the next step of the trial.
Long-term follow-up studies, on the other hand, don’t call for daily data collection, as that frequency would be overkill. The rub lies in pinpointing the perfect modality and rhythm for gathering data from patients over the long haul, all while keeping them hooked and hanging onto retention rates.
Designing long-term follow-up studies: Adapting to future technologies
Another consideration when designing an LTFU study is the pace of technological change. When designing a 10-year study today, it’s difficult to anticipate which technologies will be common a decade from now. Sponsors must ensure the systems and processes being built for LTFU studies can adapt to the next generation of digital technology.
Cloud-based decentralized clinical trial (DCT) platforms offer powerful tools for LTFU study sponsors, allowing them to collect patient data without requiring patients to travel to their clinical trial sites. This can be especially beneficial for patients who have participated in oncology or cardiology trials, as the experience can be upsetting. The scalability of DCT platforms and the flexibility of DCT tools provide sponsors with the adaptability needed to collect patient data throughout the LTFU study’s lifecycle.
Here are three strategies trial sponsors can employ to optimize data collection for LTFUs:
1. Make sure tools and protocols are familiar to the patient
Cloud-based decentralized clinical trial (DCT) platforms offer powerful tools for LTFU study sponsors, allowing them to collect patient data without requiring patients to travel to their clinical trial sites. This can be especially beneficial for patients who have participated in oncology or cardiology trials, as the experience can be upsetting. The scalability of DCT platforms and the flexibility of DCT tools provide sponsors with the adaptability needed to collect patient data throughout the LTFU study’s lifecycle.
It also should be clear to patients what exactly is required of them. For example, a patient who had been receiving weekly or monthly treatments during a yearlong clinical trial needs to be aware that the LTFU study will require follow-up data for four years, but only at six-month intervals.
By communicating LTFU expectations clearly to patients, giving them tools they recognize from the clinical trial (such as a patient-facing app), and leveraging DCT eClinical platforms for data collection, sponsors increase the chances of a successful LTFU study.
2. Keep patients engaged
Some LTFU studies go on for five or 10 years. For these types of multiyear studies, it is imperative that patients are kept engaged along the way. If a sponsor needs data from the patient every six months, it must communicate with that patient frequently. If you’re a patient and receive a notification five months and 29 days after the last session asking you to log in and enter your data, you may struggle with the tools and processes because you haven’t used them recently and be unlikely to log back in.
Huge gaps in engagement increase the chance that LTFU study patients won’t enter their data. Even simple check-ins and reminders that their next visit (site or virtual) is in five months, four months, three months, etc., can be effective. Countdowns and other reminders help patients stay engaged.
Another method to keep patients engaged is to consistently remind them of how their data is making a valuable contribution to medical research that eventually may save and improve lives. Such reminders can instill pride and commitment in patients.
3. Make participating convenient and easy
LTFU studies are an area ripe for gamification. You want people to remain active and interested in the study, and research across numerous industries show that the gamification of a person’s experience can have a positive impact on their motivation to engage.
People want to keep ‘playing,’ they want to get to that next level.” This competitive impulse can be leveraged for LTFU studies to keep patients involved and invested in entering the data requested of them.
Conclusion
Consistently collecting patient data over many years is extraordinarily difficult for LTFU study sponsors. Not only is it hard for them to prevent participant attrition over many years, they also must incorporate tools and processes adaptable to technologies still to emerge.
Decentralized clinical trial (DCT) technologies can be used to optimize data collection for LTFU studies, enabling sponsors to assemble complete sets of patient real-world data that can be used to accelerate drug development and improve treatments.
Sean Lynch is the vice president of clinical operations at Curebase, whose mission is to bring quality medical innovations to patients faster and improve human well-being through more efficient clinical studies.
Filed Under: clinical trials, Drug Discovery
