Central imaging in successful oncology clinical trials.
Our ability to understand and treat cancer has evolved with the
- increase in drugs targeting an expanding array of therapeutic targets,
- development of progressively comprehensive data sets, and
- emerging computational analytics, all of which are reshaping our treatment strategies.
Medical imaging plays a crucial role in the clinical development of solid tumours therapeutics.
A more robust linkage between drugs and underlying cancer biology is blurring historical lines that define trials on the basis of cancer type. The complexity of the molecular basis of cancer, coupled with manifold variations in clinical status, is driving the individually tailored use of combinations of precision targeted drugs.
This approach is spawning a new era of clinical trial types.
Success of developing a novel targeted therapeutics agent relies on
- real‐time multi‐omic analytic and
- integrated interpretation of efficacy using machine learning in the context of real‐world data sets.
Coupling the analytic capabilities of large centers to the tailored delivery of therapy in the community is forging a paradigm that is optimizing service for patients.
Understanding the importance of these evolving trends across the health care spectrum will affect our treatment of cancer.
The medical imaging industry is in a constant state of flux — due to increased investment in medical imaging companies, as well as mergers and acquisitions.
Today more than ever, adoption of novel imaging technologies to support clinical trials for the pharma, biotech, and medical device industries continues to increase.
The Food and Drug Administration (FDA) opened the door for imaging modalities to be used as a product development tool in pharmaceutical or medical device clinical trials by allowing data generated through imaging modalities to be included in regulatory submissions.
FDA released guidance documents, such as “Clinical Trial Imaging Endpoint Process Standards”, outlining approaches to optimize the quality and collection of clinical trial imaging data.
This document describes standards that sponsors can use to ensure that clinical trial imaging data is obtained in a manner that:
- Complies with trial protocol and standards,
- Maintains imaging data quality within and among clinical sites, and
- Provides a verifiable record of imaging process
Today’s oncology R&D programs require precision in early go / no go decisions and clarity on the treatment impact.
Our experts at IAG, Image Analysis Group provie standardized, anonymized and objective grading of study images by trained graders who are neither aware of nor influenced by knowledge of the patient characteristics or treatment arm assignment. This produces more accurate and unbiased grading. In addition, since all images in the study are graded by a small group of graders using standardized grading protocols, there is less variability in the interpretation of the imaging modalities.
Despite the FDA’s guidance on the imaging endpoint process, the research shows, that variability of site reads vs central reads is typically between 5-30%.
Use of modern trial infrastructure with centralized data collection, sharing and review alongside expert image review helps to reduce this variability. IAG’s project managers and technology team work together to ensure seamless support of central imaging dat acollection and review. We believe that
Central Imaging is essential for the conduct of multicenter clinical trials and can make major contributions to the success of that study.
If you are planning a new trial in oncology, this is where we can help to think through the trial design, optimal use of imaging biomarkers, use of cloud platform for imaging data central review and use of AI – to assess complex manifestations of the new treatments.
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About IAG, Image Analysis Group
IAG, Image Analysis Group is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. Our dynamic Strategy, Trial Solutions and Bio-Partnering divisions work closely to meet critical needs of biotechnology companies: funding, clinical development, and monetization of their assets. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed.