As part of an ongoing effort to improve efficiencies and increase patient centricity, long-term follow up (LTFU) studies are increasingly using decentralized clinical trial (DCT) models and reducing the need for patients to visit physical investigator sites.
While the prospects of cutting study costs and reducing patient burden are attractive, sponsors considering the transition to a decentralized LTFU study need to understand the inner workings of the DCT model and how the challenges differ as compared to a traditional model. This article discusses how a successful DCT model can integrate technologies, make use of Patient Service Centers (PSCs), leverage a network of providers and manage and monitor data in these often protracted studies.
The ongoing need for long-term follow up studies
Even though it can take more than a decade for a new therapy to reach the market, clinical trials only examine the immediate, short-term effects of a treatment in a select group of participants. Studying the long-term effects of a developmental or already-marketed therapy is often essential to assess the ongoing safety and efficacy of a treatment.
LTFU studies are particularly important where a therapy provides long-acting or even permanent changes in the human body, as discussed in the U.S. FDA guidance document, “Long Term Follow-Up After Administration of Human Gene Therapy Products.” Treatments that involve CAR-T, gene therapies, oncologics, biologics or those affecting the central nervous system are often studied for up to 15 years post-treatment – and may even be a requirement to measure overall survival benefit, such as in oncology trials, where the approval of the therapy is often based on progression-free survival (PFS).
Strengthening retention with a decentralized model
LTFU studies usually re-enroll the same patients from the clinical trial where treatment was administered – and treatment may even continue. The key for the LTFU trial to succeed is minimizing the number of patients who refuse to continue to the LTFU study, or who drop out from the study.
Study “fatigue” is a significant issue for LTFU studies. Patients can lose interest in the study over time or want to move on from the treatment phase of their disease. A sponsor must identify the key challenges to patient retention and determine how to increase convenience for participants by ensuring the LTFU study is as easy as possible – or even useful for a patient.
Even if the clinical trial for a therapy was run in a traditional, site-centric manner, the LTFU study can adopt a decentralized model. Instead of directing patients to the study site, a sponsor could consider using a combination of home health providers, telemedicine and local PSCs. This shift often brings the study physically closer to the participants and strengthens retention by eliminating the hassle and time involved with travel to a study site. Beyond retention benefits, a decentralized model can also provide significant cost-savings if remote monitoring is considered appropriate for the required assessments.
Building on existing relationships
By enrolling in a LTFU study, patients often benefit from the oversight of the same study investigator who has gained extensive knowledge about the clinical trial. The study investigator can also request permission to obtain the patient’s data gathered by their personal physician to compile additional information about the patient’s health status. This connection to local doctors can also improve the efficiency of the investigator site and eliminate potentially redundant procedures or data collection.
The value of combinable data
When running a LTFU study, sponsors should consider how their data sources are connected and how the results are monitored. LTFU data should be easily combinable with the previous trial’s study data. If a central laboratory was used for sample analysis during the routine trial testing, then using the same methodology in the LTFU study will ensure the data can be combined and are equivalent.
To provide sponsors with more efficient access to the central laboratory for their LTFU studies, Covance has leveraged its relationship with LabCorp’s network of over 1,900 PSCs and Specialty Testing Group laboratories. Samples collected in the patient’s home or at a PSC are sent to the Covance central laboratory, eliminating the need for local testing laboratories, and allowing the data from the clinical trial and the LTFU study to be fully combined.
Creating an infrastructure of support
Even with combinable data, sponsors need to get the most value from their results. The LTFU studies must have an efficient monitoring plan in place, and data sources must be reconciled and easily available in an integrated data repository platform.
Uniting all these critical elements requires a well-designed ecosystem of services, such as:
- Access to clinical testing capabilities;
- Support from patient contact centers that maintain study blinding;
- Management of patient scheduling and support needs; and
- Coordination of each patient touchpoint, such as the electronic patient-reported outcomes and PSCs, which can be highly tailored to best meet the needs of the study participants.
By balancing the needs of the sponsor, investigators and patients, it’s possible to improve the overall patient experience and help ensure the success of LTFU studies.
Ultimately, introducing DCT elements into an LTFU study will promote protocol compliance and patient retention, supporting more complete data to deliver strong insights into the long-term safety and efficacy of new therapies. In summary, decentralized LTFU studies can simplify meeting regulatory requirements while improving trial execution and patient experience.
To learn more about how Covance can help you build efficiencies into decentralized long-term follow up studies, please visit our landing page.
You can also find additional resources like case studies, white papers, scientific articles and more at www.covance.com/DCTeducation.