Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis Review uri icon

Overview

MeSH Major

  • Amyloidosis
  • Clinical Trials as Topic
  • Practice Guidelines as Topic

abstract

  • This manuscript summarizes the recommendations that emerged from the first Roundtable on Clinical Research in Immunoglobulin Light-chain Amyloidosis (AL), a meeting sponsored by the Amyloidosis Foundation (Clarkston, MI, USA) to develop a consensus of experts on a modern framework for clinical trial design and drug development in AL. Recent diagnostic and technical advances in AL, and updated consensus guidelines for assessing hematologic and organ responses, enable us to define study populations, appropriate end points, and other criteria for all phases of clinical research. This manuscript provides a framework for the design and conduct of systematic collaborative clinical research in AL to encourage more rapid testing of therapies and to expedite new drug development and approval.

publication date

  • November 2012

Research

keywords

  • Review

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1038/leu.2012.100

PubMed ID

  • 22475872

Additional Document Info

start page

  • 2317

end page

  • 25

volume

  • 26

number

  • 11