Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis Journal Article
| Authors: | Comenzo, R. L.; Reece, D.; Palladini, G.; Seldin, D.; Sanchorawala, V.; Landau, H.; Falk, R.; Wells, K.; Solomon, A.; Wechalekar, A.; ZonDer, J.; Dispenzieri, A.; Gertz, M.; Streicher, H.; Skinner, M.; Kyle, R. A.; Merlini, G. |
| Article Title: | Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis |
| 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. © 2012 Macmillan Publishers Limited. All rights reserved. |
| Keywords: | treatment outcome; review; clinical trials as topic; consensus; amyloidosis; practice guideline; drug development; information processing; practice guidelines as topic; clinical research; endpoint determination; immunoglobulin light chain; conceptual framework; clinical trials; organ injury; clinical trial (topic); free light chains |
| Journal Title: | Leukemia |
| Volume: | 26 |
| Issue: | 11 |
| ISSN: | 0887-6924 |
| Publisher: | Nature Publishing Group |
| Date Published: | 2012-11-01 |
| Start Page: | 2317 |
| End Page: | 2325 |
| Language: | English |
| DOI: | 10.1038/leu.2012.100 |
| PROVIDER: | scopus |
| PUBMED: | 22475872 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 3 December 2012" - "CODEN: LEUKE" - "Source: Scopus" |
