Eligibility criteria

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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, defined as p-value less than or equal to 0.10 (see levels of evidence)
  • 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)

  • These will be added if the experimental arm has a statistically superior primary outcome, defined as p-value less than or equal to 0.10 (see levels of evidence)
  • These will be generally not be added if the experimental arm has a statistically nonsignificant primary outcome, defined as p-value greater than 0.10 (see levels of evidence)
    • Exception: if the secondary outcome is the basis of an FDA approval, we will add the regimen

Prioritization

Because HemOnc.org is a voluntary effort driven by the contributors, it is not possible to add every treatment regimen, in anything close to real time. What follows is a general prioritization list for adding new regimens to the more heavily studied disease pages. In some diseases, there is no randomized literature so this prioritization does not apply:

  1. New treatment regimens, evaluated in phase III RCTs (including trials not specified as phase III but having a statistical power of 90% or greater), published in top-tier journals (NEJM, Lancet, JCO, Blood, Lancet Oncology, JAMA Oncology)
    1. Control arms of RCTs cited by the paper describing these regimens
    2. Experimental arms of RCTs cited by the paper describing these regimens, if they have statistically superior findings
  2. New treatment regimens, evaluated in phase III RCTs (including trials not specified as phase III but having a statistical power of 90% or greater), published in other journals (see Sources)
    1. Control arms of RCTs cited by the paper describing these regimens
    2. Experimental arms of RCTs cited by the paper describing these regimens, if they have statistically superior findings
  3. New treatment regimens, evaluated in phase III RCTs (including trials not specified as phase III but having a statistical power of 90% or greater), published in conference proceedings (see Sources)
  4. New treatment regimens, evaluated in randomized phase II RCTs, published in top-tier journals (NEJM, Lancet, JCO, Blood, Lancet Oncology, JAMA Oncology)
    1. Control arms of RCTs cited by the paper describing these regimens
    2. Experimental arms of RCTs cited by the paper describing these regimens, if they have statistically superior findings
  5. New treatment regimens, evaluated in randomized phase II RCTs, published in other journals (see Sources)
  6. New treatment regimens, evaluated in non-randomized trials, published in top-tier journals (NEJM, Lancet, JCO, Blood, Lancet Oncology, JAMA Oncology)
    1. Control arms of RCTs cited by the paper describing these regimens
    2. Experimental arms of RCTs cited by the paper describing these regimens, if they have statistically superior findings
  7. New treatment regimens, evaluated in non-randomized trials, published in other journals (see Sources)
  8. Old treatment regimens evaluated in RCTs, identified by other means not described above
  9. Old treatment regimens evaluated in non-randomized trials, identified by other means not described above