The medical field is currently experiencing a global shortage of the contrast agents iodixanol (Visipaque™) and iohexol (Omnipaque™) due to COVID-related manufacturing plant shutdowns in China. The global supply of these imaging agents is expected to be limited through May and June 2022.
Many research protocols require contrast agents for imaging procedures. Institutions, investigators and sponsors are understandably concerned about how to manage this issue, and how to continue studies with appropriate alternate imaging procedures that allow them to maintain participant safety and keep research programs on track and compliant.
If your research study requires the use of imaging studies that include these contrast agents for studies or study sites that are overseen by WCG IRB, we recommend the following steps:
- For a planned protocol deviation due to the contrast shortage (i.e., you know you will use a different imaging procedure than is specified in the protocol but it has not happened yet), please submit a protocol deviation as a Change In Research for the protocol at your site. A single submission may cover more than one participant on a given study, if the changed imaging procedures are all still planned. (Note that this approval would only cover participants for whom the changes in planned imaging have not yet occurred)
- For a deviation that has already happened at your site (i.e., you have already imaged participants using a different imaging procedure than was specified in the protocol), please submit a Promptly Reportable Information form. A single submission may cover more than one participant on a given study, if the changed imaging procedures have all happened already.
- If your institution has issued an institution-wide policy on reducing the use of these contrast agents, the specific plan for managing the shortage for each protocol will need to be reviewed because the impact on the study and research participants will depend on the specific details of the study. The IRB cannot review an institutional plan across all studies as a single review, because it is required to assess protocol modifications for each protocol.
- WCG IRB recommends that sponsors issue protocol amendments (or administrative letters, or any other format of protocol change) to allow for adjustments to imaging modalities (e.g., to allow the use of MRI or other alternatives) where this is feasible. This will allow the IRB to review and approve the plan for the protocol with a change that applies to all sites and all participants, rather than reviewing Changes in Research and/or Promptly Reportable Information forms for each individual site.
WCG IRB continues to support the needs of our researchers by providing guidance to institutions, investigators, and sponsors to minimize the impact of this pandemic-related shortage on clinical trial progress.