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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 2317-2325 |
| Number of pages | 9 |
| Journal | Leukemia |
| Volume | 26 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 2012 |
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Keywords
- Amyloidosis
- Clinical research
- Clinical trials
- Free light chains
ASJC Scopus subject areas
- Hematology
- Cancer Research
- Anesthesiology and Pain Medicine
Cite this
Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis. / Comenzo, R. L.; Reece, D.; Palladini, G.; Seldin, D.; Sanchorawala, V.; Landau, H.; Falk, R.; Wells, K.; Solomon, A.; Wechalekar, A.; ZonDer, J.; Dispenzieri, Angela; Gertz, Morie; Streicher, H.; Skinner, M.; Kyle, R. A.; Merlini, G.
In: Leukemia, Vol. 26, No. 11, 11.2012, p. 2317-2325.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis
AU - Comenzo, R. L.
AU - Reece, D.
AU - Palladini, G.
AU - Seldin, D.
AU - Sanchorawala, V.
AU - Landau, H.
AU - Falk, R.
AU - Wells, K.
AU - Solomon, A.
AU - Wechalekar, A.
AU - ZonDer, J.
AU - Dispenzieri, Angela
AU - Gertz, Morie
AU - Streicher, H.
AU - Skinner, M.
AU - Kyle, R. A.
AU - Merlini, G.
PY - 2012/11
Y1 - 2012/11
N2 - 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.
AB - 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.
KW - Amyloidosis
KW - Clinical research
KW - Clinical trials
KW - Free light chains
UR - http://www.scopus.com/inward/record.url?scp=84869081202&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84869081202&partnerID=8YFLogxK
U2 - 10.1038/leu.2012.100
DO - 10.1038/leu.2012.100
M3 - Article
C2 - 22475872
AN - SCOPUS:84869081202
VL - 26
SP - 2317
EP - 2325
JO - Leukemia
JF - Leukemia
SN - 0887-6924
IS - 11
ER -