Choosing the right medical imaging services partner can save your clinical trial

It’s never too late to course correct

Mark Endres – SVP, Project Management and Imaging Operations at Clario

Clinical trials are essential for developing new medical therapies, but conducting a successful trial is very challenging. It is also becoming more expensive and complicated to get a new medicine through regulatory approval as health authorities mandate more complex endpoints and impose guidelines and increase scrutiny regarding trial diversity. When medical imaging is used to support drug safety as well as primary or secondary endpoints, the situation can even be more complicated.

Selecting the right medical Imaging Core Lab (ICL) at the onset of a clinical trial is critical and can significantly reduce risks to trial integrity. However, challenges can still arise during a clinical trial, and having access to expert intervention can be invaluable in the event a study is in peril and needs to be “rescued.”

When a clinical trial is at risk, experienced teams of experts can save it by navigating complex issues and providing solutions that keep the trial on course. This reduces the risk of failure and supports the successful completion of the study with reliable results, offering peace of mind to all stakeholders involved.

The following examples provide insight on how Clario has used its expertise and agility to rescue studies.

Ensuring continuity and timely completion  

One of the most significant challenges of rescuing a clinical trial is ensuring continuity and adherence to critical path deliverables. This was evident in a phase III registration trial for a novel imaging agent to improve the detection of recurrent prostate cancer. The trial was at risk during the independent central image review because the assigned readers were not following the Independent Review Charter (IRC). Clario was hired at this crucial time to course correct and put the study back on track. Clario’s first step was to quickly establish a network of prostate key opinion leaders (KOLs) as readers. A new truth panel read design was developed and unique independent review applications tailored to the different radiologist review groups allowed the trial to stay on track. By accomplishing this complex task in just four months, Clario facilitated the transfer of the read results on schedule for health authority submission and ultimate approval. 

Retaining study integrity  

Maintaining high standards of data integrity and quality is a non-negotiable essential in clinical trials. When a trial is rescued, ensuring that the data remains consistent and meets regulatory standards is paramount. This was evident in a large phase III pivotal head/neck cancer study where medical imaging was serving as the primary endpoint. The sponsor was concerned by the high reader adjudication rate identified in the completed reads from the prior ICL. Clario was hired to take over the study. Thousands of medical images from the initial selected ICL were transferred to Clario, which conducted a quality assessment and developed a new read design and IRC to align with the protocol and meet regulatory requirements. Clario completed this work in three months, allowing new reads to be initiated. The adjudication rate was almost halved due to the thorough reader training and monitoring implemented by Clario.  

Meeting critical endpoints  

Achieving the endpoints of a clinical trial is vital for the approval and eventual market entry of new therapies. Successful intervention in a struggling trial can ensure these endpoints are met, even when the trial is under significant strain. A sponsor reached out to Clario for a phase II Sarcoma study after the FDA raised concerns that the readers were not following IRC rules, about how prior therapy information was handled, about how the reader roles (primary and adjudicator) were managed, and about site vs. central reader discordance. Clario committed to re-read the study in an expedited manner for the sponsor. A dedicated team of Clario Subject Matter Experts (SMEs) were assigned and met twice a week with the sponsor. A smooth transition followed and, in just five weeks, the image data was re-read by Clario and results transferred to the sponsor for submission to the FDA.

Conclusion

Rescuing centralized imaging services within clinical trials requires a highly approachable, consultative, and responsive team that can adeptly guide the sponsor throughout the transition process. A successful study rescue starts with defining a clear process for handling image receipt and reconciliation from the prior ICL. This is followed by an expert medical imaging review of the IRC and the study endpoints. Executing the reads and ensuring reader quality throughout the process is paramount. Delivering timely, high-quality results and supporting the sponsor through health authority submission is a cornerstone of the services Clario provides to clinical trial sponsors and often the most rewarding aspect of the work done by our qualified teams.

At Clario, we are dedicated to advancing medical therapies leveraging our 50 plus years of experience and scientific knowledge. We are proud of our track record of supporting the rescue of 36 different clinical trials over the past 5 years and the vital role we played in ensuring that the sponsors of these important studies achieved their goals. We are also proud of the depth of knowledge retained across our scientific and operational teams. We are dedicated to retaining and supporting the development of our staff, empowering our team members to continuously learn and grow from our study experiences over time.  

Our combined expertise and rigorous processes have uniquely positioned us to succeed in rescue scenarios. We are grateful for the trust sponsors place in us to safeguard their critical imaging data and will be here to support them in any capacity – just as we have for decades. Whether at the beginning, middle, or end of a trial, our team is ready to step in and provide the support needed to deliver quality results.

For more information about our award-winning products and solutions, please visit www.clario.com