Jane Myles

Long-term follow-up (LTFU) studies to clinical trials are invaluable in evaluating the safety and efficacy of a treatment. These studies can reveal critical information about the long-term safety and side effects of treatments that can’t be captured in typical clinical trial timeframes. Follow-up studies also enable a longitudinal, evidence-based assessment of a treatment’s overall benefits and costs.

Long-term follow-up studies can range from a few months to more than 10 years. The length of these studies is reliant on several factors, including the desired purpose of the study, the defined endpoints, the type of clinical evidence needed, etc. LTFU studies may be required by the Food and Drug Administration for a range of trial types, from low-risk treatments to validate treatment safety to complex oncology, cardiology, and rare disease treatments.
Whatever their duration, follow-up studies face significant challenges. Many patients, for example, may not want or be able to return to a trial site every time a check-in is needed over the course of what could be years. In addition, site-based follow-up studies involving large numbers of patients are costly and can result in low patient retention.

That’s why it’s essential that sponsors design clinical trials with the end in mind. Understanding and anticipating the needs of patients and researchers from the beginning of a study through the completion of long-term follow-up will result in better treatments and more efficient, less costly trials.
Fortunately, the emergence of decentralized clinical trial (DCT) technologies is making it easier for sponsors to run long-term follow-up studies. DCT tools provide trial sponsors with flexibility in trial design and execution, which can benefit LTFU clinical studies in numerous ways.

Under a location-based trial site model, patients must return to the site for post-treatment monitoring. This can be particularly challenging for studies where patients have traveled long distances to participate in the initial trial. These logistical and financial challenges for patients can result in low retention rate due to the added cost and time needed to gather sufficient data from these patients.

DCT technology can allow long-term follow-up study sponsors to gather data remotely that previously required a site visit from a patient. Let's say lab values have to be done after the trial treatment period is over and they have to be drawn every three months. DCT technology can offer patients an optionality to choose how they provide their lab results to researchers. This optionality means that with DCT technology, patients can choose to have mobile nurses or phlebotomists come to their homes to collect necessary samples. Not only does this remove geographic barriers, but it also makes participating in these long-term trials more convenient for patients.

DCT platforms allow for a lot of variability. They support at-home services such as the ordering and tracking of data, electronic clinical outcomes assessments (eCOA) for patient-recorded outcomes, telehealth, the use of wearables data, and much more.

These types of options can reduce the burden on the patient and save time for the investigator while ensuring continuity of data collection. They also can help patients with life-threatening illnesses, such as cancer patients who have been through clinical trials, avoid the trauma of having to return to the site for a follow-up study.

Site-based trials have established protocols for situations in which, say, a signal indicates cardiotoxicity in a patient. As sponsors deploy DCT platforms for trials and LTFU, they need to think through how they would use these tools in every conceivable scenario. Do they let the treating physician deal with the signal and then inform the investigator? Protocols should be worked out in the design phase of the trial to avoid unnecessary disruption of data collection in follow-up studies.

A way to address these logistics would be to ensure sponsors are bringing DCT vendors in early on in their trial design. The right DCT vendor can run long-term follow-up studies from start to finish with experience to establish the necessary protocol and the flexibility to give sponsors and patients optionality.

Until now, the clinical trial industry hasn’t designed studies with the end in mind. This has created problems for follow-up studies in collecting data and controlling costs. Designing with foresight can avoid the need for a sponsor to seek FDA approval to make a change mid-trial. This possibility has been one of the biggest obstacles to moving beyond traditional study sites for LTFUs. As trial sponsors ramp up their use of DCT technologies, it is important that they carefully plan every detail of their initial and follow-up studies.



Jane Myles is VP, Clinical Trial Innovation, Curebase.

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