The FDA’s recent guidance placed an increased emphasis on patient-reported outcome measures (PROMs) for oncology trials. This data provides better insight into the patients’ disease-related symptoms, side effects of treatment, and effect on physical and role functioning, and should therefore be evaluated beside tumor response and survival data in new drug applications.  Due to the growing importance of PROMs, there is an industry-wide demand for thoughtful data collection strategies.  

Many sponsors have already switched from traditional, paper-based methods to electronic collection outcome assessments (eCOA) for this very reason. Some eCOA providers have taken the technology a step further by tailoring the solution to meet the specific needs of oncology protocols and patients, creating a rapid-to-implement, pre-configured eCOA solution.  

Oncology is a logical therapeutic area to implement a pre-configured eCOA solution. These studies often see an overlap in the protocols, meaning the same comprehensive library of validated questionnaires and assessments can be used for all the related indications.  

This doesn’t mean that a rapidly deployable solution cannot be further customized to meet the more specific needs of a trial. The best eCOA providers will accommodate the desired assessment schedule, and study design characteristics to meet the needs of each individual study.    

Choosing a pre-configured eCOA solution will deliver the same standards of data quality you’d find with custom builds, but at a fraction of the cost and time. Let’s explore the top three reasons you should consider a pre-configured eCOA solution for your next oncology study.  

  1. QUALITY 

A pre-configured eCOA solution brings all the benefits of electronic data capture: PROMs are attributable, legible, contemporaneous, original, and accurate. It enhances data quality through application of pre-built standard functionality, reducing testing requirements and ensuring consistency across studies. You can be confident that the solution’s validated instruments, included from the eCOA library, will be administered in the same way. The software has also been designed to include common functionalities required by oncology studies, such as treatment cycle rescheduling, which ensures the solution meets the specific needs of oncology trials.  

  1. COST 

Pre-configured solutions are typically 20% less expensive than bespoke eCOA builds. These savings are based on the lower effort required for design and build activities.  

  1. DELIVERY 

Instead of waiting weeks, a working prototype arrives ready for immediate use. Custom builds typically take around 12 weeks to prepare, but a pre-configured solution will require no more than 8 weeks. 

What pre-configured eCOA solution should oncology studies choose? 

You should look for a pre-configured solution that includes 24/7 support. Whether you need help with logistics or analytics, the right help can mean the difference between approved treatments and failed studies.  

It’s also important to consider the ways the eCOA provider developed the solution. Does the provider have the necessary experience to offer best practices? Signant Health does. The evidence generation company has leveraged their experience supporting over three hundred oncology studies to create a pre-configured eCOA solution that saves both time and money.  

What does an oncology pre-configured eCOA solution include? 

Not all pre-configured eCOA solutions are created equal. Some may include provisioned devices if a bring-your-own-device model is not desired. Many offer a robust, built-in library of standard design elements based on the therapeutic area.  

Signant’s pre-configured eCOA solution is comprised of two core components:

  1. An extensive eCOA library of pre-validated, oncology-specific, patient-reported outcome measures

2. A pre-validated study template containing the configurable and standardized functionality required by oncology trials

Want to learn more about how our pre-configured eCOA can support your next oncology trial? Connect with our team today.

Signant Health

Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently generate quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 400 sponsors and CROs of all sizes – including all of Top 20 pharma – have trusted Signant Health solutions for remote and site-based eCOA, eConsent, IRT, supply chain management, and data quality analytics.

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