Medical Imaging in Clinical Trials

Clinical Trial Services

Medical imaging is a routine practice for healthcare professionals. The images produced are used as a clinical tool to help diagnose, stage the severity of diseases, and guide the physician towards an appropriate treatment plan. Image evaluation is a qualitative process that complements other clinical assessments by providing visual insights into the patient’s condition.

Medical images can help physicians identify participants who would benefit from specific treatments and qualify for clinical trials. Often, imaging is a required element of a clinical trial and may be used as a measuring tool to assess the quantitative changes of a disease state to determine if the treatment being researched is effective.

Additionally, medical imaging can improve the quality of data throughout a clinical trial. Utilizing the imaging process at the beginning of a trial aids in the trial being effective and more efficient. The captured images offer physicians  a series of visual snapshots that help assess the effectiveness of the trial treatment, monitor disease progression, and identify potential side effects contributing to more accurate and meaningful study outcomes.

Advantages of medical imaging:

• Non-invasive diagnosis and monitoring
• Improved treatment planning
• Early detection of abnormalities
• Provides guidance during procedures

Different types of imaging:

• Cross-sectional imaging (MRI and CT)
• Ultrasound
• X-ray based (x-ray, angiography)
• Ophthalmic imaging (OCT and fundus photography)
• Camera-based imaging (endoscopy and skin photography)

FDA has a guidance document available, “Clinical Trial Imaging Endpoint Process Standards, Guidance for Industry,” that showcases the importance of imaging in clinical trials. Evidence has shown that when the imaging process is completed in accordance with standards and regulatory requirements, the challenges in a clinical trial are decreased dramatically.

Imaging can enable investigators to evaluate the effectiveness of the trial treatment at an earlier stage than initially projected. Given the high costs associated with clinical trials, early determination of efficacy can contribute to reducing the overall trial expenses and potentially expedite the achievement of the study endpoints.

To learn more about our services and how we can support your project, please contact us today 855.463.1633 | askmed@medinstitute.com.