In the race against COVID, clinical trials regularly made the headlines. People questioned how clinical trials were carried out and a great deal of false information was spread. Imaging CROs are also sometimes the victim of false information and misconceptions. In this blog, we explore some of the myths we commonly hear.
1. There is no need for imaging CROs in early phase trials.
In phase I-II trials, primary endpoints focus on safety and tolerability and few patients are enrolled. However, the number of questions and variables that must be checked is higher in these early phase trials than at any later phase. Preliminary efficacy endpoints are crucial for the next steps in drug development.
Keosys can provide support for early phase trials with consultancy services, site training, and collect and hold services. Central reading services remain simply an option should initial results look promising. In this way, imaging can be managed with a relatively small budget.
2. The clinical CRO selects and qualifies sites. The imaging CRO does not need to be involved in the early stages of the trial.
Imaging can be a key aspect of a trial. If sites are not capable of acquiring images as described in the Image Acquisition Guidelines, images will be of poor quality for central reads. By taking part in site qualification, Keosys qualifies and trains sites to ensure that they acquire images in a standardized manner throughout the trial. As a result, less data is lost due to non-readable images.
3. When reader variability is high it means that central readers are performing poorly.
There are many variables that can impact image interpretation and read results: the indication, the number of time points, the number of adjudication triggers, the imaging endpoints, and more. Variability among readers does not necessarily mean that readers are performing poorly as difference in interpretation is to be expected. As described in Radiologists and Clinical Trials: Part 1 The Truth About Reader Disagreements by Schmid et al1, disagreement rates of 25% to 40% on the interpretation of an image are a reasonable benchmark, based on seven decades of consistent findings. At Keosys, adjudication rates and reading errors are monitored and actions are taken when reader performance deviates from expectations.
4. De-identification of imaging data is often an issue for imaging CROs.
Protecting personal information is one of the most important considerations in a clinical trial. At Keosys, processes are in place to ensure no patient information leaves the investigator site. When study images are uploaded to Keosys software, images are automatically de-identified. A quality controller also checks that sites didn’t add by mistake any data where patient identifiers could be present (e.g., screenshots, reports, etc.). If found, the data is immediately deleted from the database. With photography, there is an additional step: patient specifications (e.g., eyes, tattoos, birthmarks) are masked to ensure the patient is not recognizable.
5. When the trial is straightforward, a couple of weeks for project setup should be enough.
There are many steps to follow when developing a study-specific platform. These steps are the same for both standard and complex trials. Documentation needs to be written, reviewed, and signed off on by the sponsor. The development team then develops the platform, which needs to be thoroughly tested before deployment. Once the platform is delivered, users at sites need to be trained for the upload of images. From experience, we at Keosys know that for a standard study, at least 4 weeks are needed for project setup before FPI.
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 Schmid AM, Raunig DL, Miller CG, Walovitch RC, Ford RW, O'Connor M, Brueggenwerth G, Breuer J, Kuney L, Ford RR. Radiologists and Clinical Trials: Part 1 The Truth About Reader Disagreements. Ther Innov Regul Sci. 2021 Jul 6:1–11. doi: 10.1007/s43441-021-00316-6. Epub ahead of print. PMID: 34228319; PMCID: PMC8259547