Study visits, administrative time, screening failures, advertisement, recruitment fees, and non-standard-of-care fees are common elements of the clinical trial budget associated with a study protocol. Other financial impacts for trial participants involve non-medical, out-of-pocket participant costs. Many sponsors provide support to defray these costs, which frequently include reimbursement or upfront payments for travel, lodging, meals, childcare, and other items. However, there is significant variability across geographies, institutions, sponsor companies, and third-party vendors in whether and how these programs are provided.

Site staff that work with oncology clinical trial sponsors and help enroll patients play a crucial role in ensuring that study participants have the support they need to successfully participate in the trial. This is especially true of the non-medical impact on patients – the financial and logistical burdens can often be overwhelming. It is important that site staff be knowledgeable about both the needs of their patients and the program offerings from sponsors that are included in a clinical trial protocol.

As part of the EACT Project, a working group focused on educating the care team about available financial support programs has developed this Checklist for Clinical Trial Staff.

While this information is often included in the study protocol and referenced in the informed consent form (ICF), this checklist provides a quick resource as a fillable PDF that site staff can use when discussing new trials with sponsors.