Patient OutcomePatient C is excluded from trial enrollment as there are strict inclusion and exclusion criteria.
After appropriate HCP referral, patients can often face hurdles in meeting clinical criteria and/or running out of time while healthy enough to enroll.
Diagnostic and treatment journeys leading to consideration of a CAR-T therapy vary significantly from person-to-person.
The FDA approves these trials...and the doctor cannot deviate from the protocol. An example I'll give is the bone marrow biopsy. In the three times she had Lymphoma, she never had any positive bone marrow, and because of the protocol she had to get four different bone marrow biopsies...it got to be too much
The caregiver's perspective
Complex inclusion/exclusion criteria and a lack of access to resources can preclude potential study participants, especially from underrepresented populations.