Making Radiation Therapy Review Standard in Oncology Trials

Cancer trials often focus solely on the investigational drug or device, however, when radiation therapy (RT) is part of the treatment regimen, a critical variable is often overlooked: variations in how radiation therapy is planned and delivered.

Deviations from radiation therapy protocols have been linked to higher risks of treatment failure and increased overall mortality in clinical trials (1, 2). Despite the potential impact on overall survival, RT treatment protocols are not always enforced and rarely validated through review (3).

At Aitrium, we believe RT plan review should be a standard part of every oncology trial design where RT is present. In an attempt to solve this problem, we’ve developed Trial Accelerator.

Radiation Therapy: An Overlooked Variable in Oncology Trials

Radiation therapy isn't a static modality. Variations in imaging, contouring, dose planning, and delivery can significantly impact patient outcomes (4) and trial results. RT treatments are commonly reported using case report forms (CRF) without imaging (5). In other words, compliance may be assumed rather than verified.

Without a consistent, centralized method for reviewing RT plans across trial sites, two patients on the same protocol may receive clinically different care. As a result, trials risk becoming a heterogeneous mix of unknowns, limiting their ability to detect actual treatment effects.

This variability introduces noise into trial results that can:

• Distort the assessment of a drug’s true efficacy
• Obscure critical safety signals
• Introduce site-to-site bias
• Increase the risk of inconclusive or failed trials

In short, radiation therapy may become an uncontrolled variable when reduced to a checkbox on a form.

Why RT Plan Review Has Been Rare

Despite its importance, RT plan review is still uncommon in most pharma-sponsored trials. That's because traditional review models are:

• Costly: Requiring centralized infrastructure and specialized teams with labor-intensive workflows.
• Slow: Initial RT plan review can be burdensome, potentially delaying per-center credentialing, enrollment, and treatment.
• Difficult to Scale: Data standardization across global trial sites is complex and error-prone.

Unlike adherence to systemic therapy regimens, which are routinely standardized and subjected to sensitivity analyses, radiation therapy has long been considered too complex for similar analyses, especially in studies asking questions related to primary systemic therapy. The operational cost and complexity have made radiation review seem impractical for all but the largest, most radiation-focused studies. Trial sponsors have lacked a practical way to integrate RT review–until now.

Scalable, Practical Plan Review

Trial Accelerator eliminates the traditional barriers to RT plan review:

• Data Harmonization Transforms disparate, site-specific RT plans into standardized format, ready for efficient, centralized review.
• Local Deployment, Real-Time Checks Enables quality control directly at the site level, without moving sensitive data to the cloud or sending patient data.
• Streamlined Workflows Makes plan contribution and oversight fast, cost effective, and seamless, without disrupting local clinic operations.

We believe in making it practical and accessible to include radiation plan review across all trials involving radiation therapy, not just those centered on radiation outcomes. Our locally deployed application AitriumOS allows institutions to send data directly to the reviewing party – this means no additional data transfer agreement is required, greatly simplifying administrative approvals.

By making RT plan review practical and accessible, Aitrium Trial Accelerator empowers sponsors to elevate data quality, ensure protocol adherence, and protect both trial integrity and patient outcomes.

The Future: RT as a Constant, Not a Variable

When structured radiation therapy review becomes the norm, RT shifts from a source of uncontrolled variability to a reliable constant. This enhances the scientific rigor of drug and device trials, protects sponsor investment, and improves patient care. At Aitrium, we believe the future of oncology trials demands this shift. And with Trial Accelerator, that future is now within reach.