SUBJECT: FDA Draft Guidance for Industry on Cancer Clinical Trial Eligibility Criteria:
Brain Metastases
Dear Dr. Pazdur:
On behalf of the American Association of Neurological Surgeons (AANS) and the Congress of
Neurological Surgeons (CNS), we appreciate the opportunity to comment on the recently released FDA
Draft Guidance for Industry on Cancer Clinical Trial Eligibility Criteria: Brain Metastases.
Overall, we find the draft guidance reasonable and agree it balances concerns regarding inclusion and
exclusion criteria for patients with brain metastases for clinical trials of systemically administered
investigational therapies. We understand the need for the guidance to be rather general, given the broad
clinical spectrum encompassed by the term “brain metastases.” However, we are concerned that
companies may find some of the terms in the draft guidance indistinct.
For example, the definition of a stable tumor raises several questions, some of which are listed below:
- How long do lesions need to be unchanged to be stable?
- Is the definition of stable disease restricted to a stable enhancing mass?
- Is stable edema a criterion for stable disease?
- Do clinical symptoms need to be stable? If so, for how long?
…
Read full letter here
