Eligibility criteria

From HemOnc.org - A Hematology Oncology Wiki
Revision as of 21:22, 10 December 2017 by Jwarner (talk | contribs) (Created page with "'''Use of this site is subject to you reading and agreeing with the terms set forth in the disclaimer.''' Note:...")
(diff) ← Older revision | Latest revision (diff) | Newer revision → (diff)
Jump to navigation Jump to search

Use of this site is subject to you reading and agreeing with the terms set forth in the disclaimer.

Note: these eligibility criteria, which pertain mainly to treatment regimens, are guidelines; they are not hard-and-fast. For example, if a contributor or a member of our Editorial Board requests that a certain regimen be added, we will strive to do this even if the criteria are not strictly met. See the content tutorial and sources pages for more information. As outlined in our disclaimer, inclusion of a regimen on HemOnc.org is not an endorsement of its efficacy or appropriateness for use in any given clinical situation.

Non-randomized or retrospective studies

Regimens consisting solely of approved drugs

  • There is no strict cutoff for efficacy
  • The regimen should be described by the authors as equivalent or better than standard-of-care, using such terms as "promising", "new standard-of-care", "at least as good", etc.
  • If comparative efficacy to historic controls is reported, the new regimen should have a statistically superior outcome
  • The study should have at least 20 participants

Regimens that include an experimental drug

  • The study should meet its predetermined primary efficacy endpoint
  • It should be clear that the regimen will go on to be tested in phase III trials
    • Exception: if the regimen is the basis of an FDA approval, this is not required
  • With few exceptions, the study should have at least 20 participants
    • If a phase I or Ib study, this should be at least 20 participants receiving the MTD

Randomized trials

Control arm(s)

  • These will generally always be added to HemOnc.org, if they are missing

Experimental arm(s)