The race to develop novel, advanced therapeutics for cancer patients is fast and highly competitive. As treatments have progressed, so have oncology clinical trial designs. Today’s oncology trials are more complex and customizable to the individual patient than in years past. It is essential that the systems that make oncology trials possible adapt to these studies’ changing needs. Relying on legacy thinking and technology creates inefficiencies and risks that can hinder success for sites, patients, and sponsors. Adaptable, fully integrated solutions are essential to managing oncology trial complexities.
When we think of patient-centricity in oncology studies, electronic data capture (EDC) and data management systems may not be the first aspects that come to mind. However, responsible study design is a complex puzzle, with every piece centered on patient care. Studies rely on technology to collect, manage, and aggregate patient data, and the quality of this data collection directly affects patient care.
Oncology trials recruit patients with severe, life-threatening illnesses. These patients have complicated clinical profiles and greater mortality risks than other trial participants. It’s more difficult to collect their data consistently over months or years. Interestingly, they are currently less likely to participate in decentralized clinical trials (DCTs) due to the complex nature of their cancer and specialized treatments like infusions. Their care is seldom delivered remotely, though with further guidance from regulatory authorities this may shift. Therefore, much of the data collection for oncology trials is designed for brick-and-mortar investigator sites within an established healthcare structure.
Even so, clinical trial staff need to be able to collect patient data in a simple, meaningful way without being overburdened with unnecessary steps or task switching. For example, many sites participate in multiple studies. When staff must log into a separate platform for each study, they lose time. When they can use the same platform for numerous oncology studies, even across sponsors, they save considerable time and resources, not to mention having more bandwidth to focus on the patient.
In addition, the ability to access that platform on a device of their choice, such as a tablet, allows them to spend more time providing patient care and less time performing data entry. Factoring in the potential to integrate with the healthcare system’s EHR, it becomes clear that there are significant opportunities to reduce site burden in oncology research.
Mid-study changes come in many forms — from data collection modifications to adding new data sources or trial cycles. The change could reflect new information that affects the delivery, timing, and quantity of the drug or other visit protocols. Regardless of the type of change, most mid-study amendments don’t result in a single point of impact. Instead, they create a cascading effect of changes across the entire trial’s execution.
According to the Tufts Center for the Study of Drug Development1, from 2018-2020, 78% of Phase 2 and 69% of Phase 3 clinical trials required at least one substantial mid-study protocol amendment, averaging 2.7 and 3.3 amendments, respectively. At the time of the study in 2020, one Phase 3 mid-study change cost an average of $535,000 in unbudgeted expenses, resulting in a three-month delay. Given recent inflation and the rising costs of trials, protocol amendments have become even more expensive.
For oncology clinical trials, the number of mid-study changes is even higher. Phase 2 clinical trials average nearly twice the number of significant amendments, and Phase 3 trials average 40% more than non-oncology trials. From a participant perspective, the numbers are even more striking. Patients in oncology studies are involved in roughly double the number of protocol amendments than their non-oncology counterparts.
Protocol changes demonstrate the complexity and rapidly evolving nature of oncology trials. To be effective, these trials must efficiently adjust to individual patients’ changing needs. Although costly and time-consuming, oncology trials represent the forefront of targeted, precision medicine that promises to advance research and treatments in leaps and bounds.
When EDC and data management technologies began decades ago, studies were simpler and less subject to change than current oncology trials. The systems reflected old methodologies that don’t meet the needs of current studies. Today’s studies need flexibility and reactivity from the outset, which, surprisingly, begins with a simple unified design.
When “platforms” use compartmentalized structures, it’s difficult to make changes across the entire study, even though the changes affect multiple systems. Manually updating numerous compartments takes time and frequently requires pausing the study.
Given that legacy systems require taking studies offline and potentially need to be rebuilt from the ground up, depending on the needs of a given amendment, each study change creates a significant impact. A single change can take weeks or months to implement, delaying the study and risking losing patients who become frustrated when the study pauses. These mid-study changes threaten data integration and risk orphaning or invalidating study data, unless they are done in a true platform solution designed for flexibility.
A platform built on a single code base is fully integrated and highly adaptable. If a change is made in one part of the platform to support an amendment, it automatically cascades throughout the system with little to no manual intervention or additional updates. This significantly reduces the time it takes to support complex oncology research, where above average numbers of study amendments are the norm. Oncology research requires technology that is adaptable and flexible, not technology built for legacy norms and trial designs.
Oncology trials collect massive amounts of data compared to other types of studies. Phase 1 oncology trials average 27,265 data points per patient, while their counterparts only average 4,365 data points per patient1. Even in Phase 3, oncology trials collect more than twice the amount of data points compared to their non-oncology peers. These trials require advanced EDC and data management systems to manage this data smoothly and efficiently.
Today’s oncology trials need highly adaptive systems to avoid lengthy pauses due to mid-study changes. For example, since patients’ reactions to the treatment can vary widely, it’s common for patients to need more or fewer cycles of treatment than the study design allocated. Using a system that’s been built from the ground up to handle variations in cycle numbers is essential to avoiding a lengthy, costly hiatus when the patients’ needs change.
Zelta, our clinical data management and acquisition platform which includes EDC, ePRO/eCOA, and eConsent, is designed to adapt to mid-study changes and the complexities inherent in oncology studies. The system is built on a single code base, so when changes are made, they almost instantaneously flow through the system, flagging potential risks along the way. The system even cross-checks data and identifies anything missing or problematic. For instance, if an investigator decides to eliminate a data field, the system alerts the user that the data could be orphaned and thus unusable at the end of the trial. Resolving those issues efficiently helps companies avoid compliance and regulatory problems during approval.
In addition to the ability to cascade protocol amendment-related changes throughout the system, Zelta allows the study designers to deploy mid-study updates automatically, causing minutes of downtime rather than days or weeks of delays for patients and clinicians. Cycles can be added or deleted without interruption or incorrect data. Ultimately, Zelta’s built-in flexibility results in cleaner, more accurate data, and faster timelines.
Running oncology clinical trials may never be simple, but a flexible and comprehensive platform like Zelta can help sponsors and clinical research organizations cut through the complications and bring lifesaving treatments to market faster.
Watch our demo video to learn more about how Zelta can help your organization manage oncology clinical trials.
Source:
- Impact Reports — Tufts CSDD
