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

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...

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Bibliographic Details
Published inLeukemia Vol. 26; no. 11; pp. 2317 - 2325
Main 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
Format Journal Article
LanguageEnglish
Published London Nature Publishing Group UK 01.11.2012
Nature Publishing Group
Subjects
692/308/2779/109
692/699/317
692/700/1538
Amyloidosis
Amyloidosis - therapy
Biological and medical sciences
Blood diseases
Cancer
Cancer Research
Chains
Clinical trials
Clinical Trials as Topic
Collaboration
Critical Care Medicine
Drug development
Endpoint Determination
Guidelines
Heart
Hematologic and hematopoietic diseases
Hematology
Humans
Immunoglobulins
Intensive
Internal Medicine
Leukemia
Light
Medical sciences
Medicine
Medicine & Public Health
Multiple myeloma
Oncology
Plasma
Population studies
Practice Guidelines as Topic
Proteins
review
Toxicity
Canada
United States
Italy
United States > US
clinical trials
amyloidosis
free light chains
clinical research
AL amyloidosis
Hematology
Clinical trial
Clinical research
Light peptide chain
Consensus
Recommendation
Online AccessGet full text
ISSN0887-6924
1476-5551
1476-5551
DOI10.1038/leu.2012.100

Cover

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.
AbstractList 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.
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.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.
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. Leukemia (2012) 26, 2317-2325; doi: 10.1038/leu.2012.100 Keywords: amyloidosis; free light chains; clinical trials; clinical research
Audience Academic
Author Comenzo, R L
Streicher, H
Seldin, D
Sanchorawala, V
Kyle, R A
Merlini, G
Reece, D
Wechalekar, A
Skinner, M
Palladini, G
Gertz, M
Landau, H
Falk, R
Zonder, J
Dispenzieri, A
Solomon, A
Wells, K
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Issue 11
Keywords clinical trials
amyloidosis
free light chains
clinical research
AL amyloidosis
Hematology
Clinical trial
Clinical research
Light peptide chain
Consensus
Recommendation
Language English
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Snippet This manuscript summarizes the recommendations that emerged from the first Roundtable on Clinical Research in Immunoglobulin Light-chain Amyloidosis (AL), a...
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SubjectTerms 692/308/2779/109
692/699/317
692/700/1538
Amyloidosis
Amyloidosis - therapy
Biological and medical sciences
Blood diseases
Cancer
Cancer Research
Chains
Clinical trials
Clinical Trials as Topic
Collaboration
Critical Care Medicine
Drug development
Endpoint Determination
Guidelines
Heart
Hematologic and hematopoietic diseases
Hematology
Humans
Immunoglobulins
Intensive
Internal Medicine
Leukemia
Light
Medical sciences
Medicine
Medicine & Public Health
Multiple myeloma
Oncology
Plasma
Population studies
Practice Guidelines as Topic
Proteins
review
Toxicity
Title Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis
URI https://link.springer.com/article/10.1038/leu.2012.100
https://www.ncbi.nlm.nih.gov/pubmed/22475872
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https://www.proquest.com/docview/2645715469
https://www.proquest.com/docview/1143866833
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Volume 26
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