Elizabeth Williams: Can you provide an insight into the current challenges you face in clinical operations in oncology?
Howard Fingert: The challenges range from how to align working practices and SOPs (standard operating procedures) among various regions and stakeholders. At Takeda, we do a fair number of global trials, so it’s vital to stay to avoid the speed bumps that can come your way.
EW: A recurring challenge seems to be patient recruitment – can you shed any light on any innovation taking place in this area?
HF: There are numerous innovations taking place in the clinical trial space that’s making patient recruitment easier to deal with. Two examples include real world evidence and expanded access. A recent issue of the Journal of Clinical Oncology was dedicated to expanded access, the idea of bringing in more patients who were previously excluded, namely, the elderly or those with HIV, into clinical trials. If this happens then how do you manage patients in terms of quality and operations?
EW: How can this issue be remedied in that case?
HF: So, for instance, patients with HIV are often totally excluded from studies, however, there’s no valid reason to exclude. Operationally, expanded access is a good thing as one of the goals of operations is to increase enrolment metrics. If you broaden the inclusion criteria it will support a larger trial. However, sponsors are still unwilling to commit to expanded access, due to the potential implications it may have on data generation.
EW: Who’s currently leading the way in that regard?
HF: The National Cancer Institute (NCI) are really committed to doing these things for the greater good of patients by researching experimental treatments. For patients who don’t meet the inclusion criteria, or patients with HIV and other previously excluded conditions, the only way to get access is to try something very novel.