Skip to content
  • Categories
  • Recent
  • Tags
  • Popular
  • Users
  • Groups
Skins
  • Light
  • Cerulean
  • Cosmo
  • Flatly
  • Journal
  • Litera
  • Lumen
  • Lux
  • Materia
  • Minty
  • Morph
  • Pulse
  • Sandstone
  • Simplex
  • Sketchy
  • Spacelab
  • United
  • Yeti
  • Zephyr
  • Dark
  • Cyborg
  • Darkly
  • Quartz
  • Slate
  • Solar
  • Superhero
  • Vapor

  • Default (No Skin)
  • No Skin
Collapse
Brand Logo

Forum

  1. Home
  2. PAAB Q&A
  3. Claims & Support/References for Claims
  4. 282 - In the new PAAB code, it says: "The PAAB can allow the use of observational studies when specific acceptance criteria are met." What are the specific acceptance criteria? Also, does a natural history study fall under an 'observational study' or 'meta-analysis'? Thanks
PAAB Notice
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

282 - In the new PAAB code, it says: "The PAAB can allow the use of observational studies when specific acceptance criteria are met." What are the specific acceptance criteria? Also, does a natural history study fall under an 'observational study' or 'meta-analysis'? Thanks

Scheduled Pinned Locked Moved Claims & Support/References for Claims
1 Posts 1 Posters 393 Views
  • Oldest to Newest
  • Newest to Oldest
  • Most Votes
Reply
  • Reply as topic
Log in to reply
This topic has been deleted. Only users with topic management privileges can see it.
  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    A natural history study is a type of observational study which simply follows a group of people (e.g. on a drug or having a condition) over time. They tend not to have a control group and thus would not be considered as evidentiary support for claims in drug advertising. A high quality cohort study or case-control study can be considered as evidence for adherence claims. These two groups of non-experimental trials can also be considered corroborating evidence for therapeutic claims of efficacy and safety. The guidance document on our website provides more information on observational studies. For any analysis (including observational studies and meta-analyses) "high quality" means that adequate steps were taken to ensure that the observations are not due to random luck or systematic bias (whether methodological or confounding). This can only be assessed if the study report is comprehensive. For observational studies we look to the STROBE checklist, for meta-analysis we look to the PRISMA checklist. These checklists do not tell you whether a study is high-quality, but they do tell you what parameters one needs to know in order to make that assessment.

    1 Reply Last reply
    0
    Reply
    • Reply as topic
    Log in to reply
    • Oldest to Newest
    • Newest to Oldest
    • Most Votes


    • Login

    • Don't have an account? Register

    • Login or register to search.
    • First post
      Last post
    0
    • Categories
    • Recent
    • Tags
    • Popular
    • Users
    • Groups