Key considerations for implementing imaging in clinical trials

Contributing authors: Tina Kjellen, Head of Clinical Operations @ Antaros Medical and Kerstin Heurling, Head of Imaging Science and PET Imaging Director @ Antaros Medical

Across many different disease areas and indications, imaging can add a lot of value to a clinical drug development program. Drug development is a very expensive, and often risky, endeavour, and ensuring you are getting the most insights from your clinical trials is paramount.

Advanced imaging, such as Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) can uncover information that cannot be obtained in another way, it can provide insights into mechanism of action or early treatment effects. Through its precision, imaging can reduce the required number of subjects or the necessary duration of the trial, thereby reducing costs. There are so many ways that imaging can be incorporated into a clinical trial.

Figure 1: Examples of the benefits of using imaging in clinical trial

Not all clinical trials with imaging are of the same complexity, but ensuring that the imaging will give you the insights you are looking for requires some planning. Therefore, there are a few key considerations to keep in mind before the trial starts, throughout the trial, and after the data has been collected to successfully integrate imaging into a clinical trial. in this blog post, we will describe a few of the considerations that we believe are most important.

Identify early the underlying need for imaging in your clinical trial

Identifying early what the need for imaging is in your clinical trial will have implications for how the imaging should be implemented. Some questions that should be considered are, for example: Is the trial early phase to inform decision-making or later phase to provide evidence for regulatory bodies? Is the imaging endpoint an exploratory or supportive endpoint? A primary endpoint? Is the endpoint going to be used across the whole patient cohort or is it part of a sub-study?

In all cases, it is important to design an imaging protocol so that the imaging data captured throughout the trial will give you the information that you need. Unlike in clinical practice, imaging in drug development is used to help measure treatment efficacy at a group level. This means that the utility of the imaging data is determined by its precision and power, that it can reliably reproduce what it measures and that there is a high probability of it finding a true difference between two groups. Advanced imaging methods are very sensitive, and usually during power estimations it becomes clear that you will usually need fewer patients and a smaller sample size.

Something we hear quite often during the course of a trial is “can you also measure this?”, a measure or endpoint that has not been part of the original protocol. This is understandable – the field is always moving, even when a trial is ongoing. Here too, it is so important that the underlying need has informed the design of the imaging protocol. When the protocol has been optimally designed, it is sometimes possible, while still adhering to Good Clinical Practice (GCP), to extract more from the images and use all the available information.

Ensure imaging sites are selected intentionally and invest in training them well

Ensuring that imaging sites are selected intentionally and trained well is important for the feasibility of the clinical trial and delivery of the imaging data. The complexity of implementation will be determined by both the number of sites and the choice of the imaging endpoints. Some imaging endpoints can require specific scanners or hardware, or specialised expertise, which will have implications for which imaging sites are suitable for the trial. On the other hand, some disease indications and geographical locations can mean that only a few patients are recruited for each imaging site, necessitating a large number of imaging sites for the trial. These factors will determine what site selection will entail and the site training that is needed. However, regardless of the complexity of the trial, ensuring that all sites have been trained and will produce imaging in accordance with the imaging protocol is essential.

Figure 2: Illustration showing how different imaging endpoints, as well as the number of imaging sites will determine both the technical and operational complexity, with a few example.

To be confident in the reliability of the results, there needs to be consistency with how the imaging is performed across scanners and sites, and this requires adherence to the protocol. This requires site training of course, but also ongoing quality control and contact with the site throughout the trial, and retraining if necessary. Site management, from the quick start guide explaining how to set up the protocol, to the delivery of the final image, is a process that can be overlooked, but will have a direct and meaningful impact on the quality of the imaging data and on the reliability of the results

Choose the partner and people that are right for your project

Perhaps the most important consideration for implementing imaging in a clinical trial is who you partner with. This will impact the design of the trial and the imaging protocol, selection and training of the sites, the quality and reliability of the imaging data throughout the trial, and the interpretation of the insights gleaned from the analysis. The right partner will depend on the various needs of the trial:

What are the scientific needs? What expertise is needed with regards to both imaging and disease biology understanding? What questions do you need the imaging data from this trial to answer and who is needed to interpret these insights?

What are the operational needs? How many imaging sites are required and where are they? Are there certain requirements (i.e. hardware, software, staffing) for the imaging sites? Do you need access to a large, international imaging site network? Who is going to select, train, and manage the sites? What systems are needed to ensure quality and correct data handling?

University sites for example, can bring a lot of scientific expertise, but may not have the operational capacity or quality assurance set-up to accommodate larger, multi-centre trials. Contract Research Organisations (CROs) on the other hand, might have the operational infrastructure in place but may not have the flexibility to tailor solutions or be able to provide the dedicated scientific imaging expertise. This can also limit the insights that can be leveraged and interpreted from the collected data. There are then also specialty providers (like Antaros Medical) who can accommodate both sets of needs. You can read more about what we do here.

In summary

To summarise, imaging can provide a lot of value in clinical trials for drug development, but there are a few key considerations to keep in mind to ensure its successful integration:

  • Identify early what the underlying need for imaging is in your clinical trial
  • Ensure imaging sites are selected intentionally and invest in training them well
  • Choose the partner and people that are right for your project

Blog disclaimer
The views and opinions expressed in this article are solely those of the contributing author/s. These views and opinions do not necessarily represent those of Antaros Medical.

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