Author: Jill V. Platko PhD, Vice President, Scientific Services
Snapshot:
- Oncology Requires Holistic Reporting: Cancer treatment drastically affects patients physical and mental wellbeing, making capturing accurate quality of life (QoL) data especially important.
- Streamlined Site User Experiences: eCOA unified with IRT can streamline data collection and trial management and simplify sites’ user experiences.
This post is the first in a three-part series exploring how Electronic Clinical Outcome Assessments (eCOA) streamline the clinical trial process and improve data collection in the fields of oncology, dermatology, and gastroenterology.
Oncology clinical trials are complex. For patients, the stakes are extraordinarily high. Purpose-built, powerful eCOA solutions can gather core patient-reported outcomes and better track both treatment side effects and benefits in these trials. And, when unifying eCOA with an interactive response technology (IRT) on a single platform, sponsors and sites can more easily manage their trials and work with one scientific services team to respond to trial needs.
The case for eCOA in oncology: simplifying outcomes data collection
We’ve seen that trial complexity occurs in three dimensions: the protocol, the operations, and the potential for unanticipated change. Such complexity can occur in any trial but is especially common in oncology due to the heterogeneous nature of cancer, the severity of the disease, and the intensive treatment regimens involved. For example, patients often undergo a variety of therapies, including surgery, radiation, chemotherapy, and immunotherapy, all of which can have significant and varied side effects.
In addition to measuring cancer progression, data on patients’ quality of life (QoL) are important secondary endpoints in oncology clinical trials. Because cancer and its treatment can significantly impact a patient’s physical, emotional, and social well-being, it’s important to collect accurate, regular information on the patient’s symptoms and their experience throughout the trial. The Food and Drug Administration increasingly recognizes the importance of these outcomes, and recently finalized guidance on collecting patient-reported outcomes in cancer clinical trials.
Easy to implement, powerful eCOA solutions can be an important tool to help facilitate comprehensive assessments, allowing patients to report electronically on their physical and emotional well-being in a timely manner. eCOA can provide an important added value to understanding patients’ responses to cancer treatments.
Unifying technologies to simplify trials
The variety of cancer treatments, together with the increasing number of endpoints collected in oncology trials, can make simplifying trial operations by unifying eCOA with an eClinical platform an even greater benefit to sponsors and sites.
Oncology trials generate vast amounts of data from clinical assessments, laboratory results, imaging studies, and patient-reported outcomes. When eCOA runs on the same platform as IRT, it further simplifies the data collection process for sponsors and trial sites by providing one streamlined experience to navigate.
That’s what we’ve tried to do at Suvoda. The power in Suvoda’s unified IRT and eCOA products makes them uniquely suited to manage the protocol complexities of oncology trials and simplify patient outcomes data collection.
Embracing this unified eCOA and IRT approach can be a step towards advancing oncology research, responding to evolving FDA guidance, and collecting accurate data, which may ultimately lead to medications that improve outcomes and quality of life for cancer patients worldwide.
Author
Jill V. Platko PhD
Vice President,
Scientific Services
Suvoda
CASE STUDY
Explore how Suvoda's eCOA solution enhances compliance and data accuracy in clinical trials