| Jeffery J Bowden and Frank Dunn at Biomedical Systems analyse collaborative efforts to find common ground in the improvement of clinical trial imaging
The use of medical imagery in clinical trials to determine efficacy continues to offer trial sponsors enormous possibilities in terms of study design and data acquisition. But there is still room for further improvement. During the last five months, working groups comprising members of the US Food and Drug Administration (FDA) and participants from the pharmaceutical industry and imaging core labs have grappled with a myriad of ideas as they attempt to develop a foundational document for improving the imaging processes involved in clinical trials.
IMAGING STANDARDISATION DOCUMENTS
The main focus was the development of the medical imaging standardisation technical document, a white paper seeking agency guidance from the FDA on standardisation of the imaging review charter (IRC) used in clinical trials. The IRC is a document developed by clinical trial sponsors and imaging core labs that lays out processes to be used to conduct clinical trials. It details the individual corporate standard operating procedures (SOPs), summarises clinical trial protocols, details site and investigator training, explains logistics, lists roles and responsibilities, defines how the clinical data will be acquired and stored, and explains how the independent review will be conducted. In other words, it documents the overall clinical trial process.
The charter becomes part of a larger package submitted to the FDA by the clinical trial sponsor, and serves to explain how the clinical trial was conducted when the agency reviews the data and wants to better understand the medical imaging portion. The importance of the IRC to the medical imaging industry was indicated by the participation of many industry stakeholders in its development. Those involved have touted the success of collaborative effort and a consensus-building environment that fostered both lively discussion and expert analysis of the processes. This participation facilitates a common understanding of the expected agency guidance, along with creative ideas to improve the clinical trial imaging process. More importantly, it makes it easier for clients to understand the important components in |
