How Can We Think about the design and Management of Medical Imaging in Clinical Trials Strategically?

Introduction

In many clinical trials, imaging serves as a primary, secondary, or exploratory biomarker, influencing decision-making throughout all developmental phases. Medical imaging has rapidly become a key asset in drug development, providing valuable data on investigational drug efficacy, safety, and tolerability via noninvasive, quantitative, and longitudinal assessment of biological processes. With this in mind, medical imaging in clinical trials requires strategic, high-level decision-making as an integral aspect of clinical trial design, management, and execution.

Medical imaging in clinical trials must be designed into the entirety of the research study, throughout all trial phases, considered from protocol design right through to regulatory submission. This article will put the spotlight on medical imaging in clinical trials, considering the question: How can we think about the design and management of medical imaging in clinical trials strategically?

What does a strategic approach to medical imaging in clinical trials look like?

Imaging endpoints enable visual objective evidence of disease evolution and treatment effect, providing valuable early evidence to enhance clinical research findings. Sponsors must integrate imaging endpoints into protocol design early to enhance success, aligned with well-defined and validated imaging modalities and robust quality control measures. Imaging data quality and interoperability are significant operational risk factors, failures to align imaging decisions strategically and effectively, considering the ever-expanding landscape of global, decentralized clinical trials and multi-modal imaging protocols, can have a devastating effect on trial outcomes and ultimate success.

According to analysis of the clinical trial imaging market, the accuracy of clinical trial imaging reduces sample size requirements by 12%, translating to savings of $2–3 million per trial, underscoring the role of clear and effective imaging strategy as a measurable contributor to portfolio ROI. Limited interoperability between imaging software and EDC platforms remains a concern, and over 55% of sponsors cite manual data reconciliation as a bottleneck in global trials.

A truly strategic approach goes beyond selecting an appropriate imaging modality, it aligns imaging objectives with the study’s scientific hypothesis, regulatory pathway, operational feasibility, and statistical analysis to ensure imaging data are decision-enabled, reproducible, and submission-ready.

Key points for sponsors to consider:

• Start with the research question, and align imaging design accordingly
• Engage imaging experts early
• Align modality and endpoints with developmental goals
• Build standardization and quality control into trial design
• Design reader and image analysis strategy carefully
• Integrate imaging into the broader data ecosystem
• Consider regulatory expectations early
• Evaluate global site capabilities
• Consider scalability and portfolio consistency

“Perceptive works closely with our clients to ensure the design and management of medical imaging in clinical trials is considered strategically, aligned with the trial objectives, and includes measures that are likely to be viewed favorably by regulatory agencies.” – Souhil Zaim, MD, Vice President, Medical Imaging, Perceptive

Perceptive as a Strategic Partner

This is where Perceptive Imaging comes in, with proven expertise in delivering high-quality clinical trial imaging data at a global scale to worldwide biopharmaceutical organizations and CROs for nearly 30 years.

 “Perceptive works closely with our clients to ensure the design and management of medical imaging in clinical trials is considered strategically, aligned with the trial objectives, and includes measures that are likely to be viewed favorably by regulatory agencies,” explains Dr. Souhil Zaim, VP, Medical Imaging at Perceptive.

Perceptive is committed to first-time quality, evidenced by our successful inspection track record and support of 400+ approvals across various regulatory authorities, including the FDA, EMA, and NMPA. Perceptive has supported imaging strategy and implementation in 25% of all imaging trials since 1997, covering a wide range of therapeutic areas and leveraging a vast network of imaging experts.

Perceptive is a globally leading imaging core lab, delivering scientific expertise and scalable operations from offices around the world,. This longstanding history of imaging excellence has honed our expert strategic approach, integrating scientific insight with operational excellence, and driving confident imaging-enabled decision-making throughout the clinical development lifecycle.