RHAPSODY, Biomarkers and Novel Clinical Trial design in type 2 diabetes (T2D) and prediabetes

Developing a novel therapeutic product for the treatment of type 2 diabetes (T2D) is a long, resource‐intensive process. Novel biomarkers could potentially aid clinical trial design by shortening clinical trials or enabling better prediction of at‐risk populations and/or disease progression. Novel c...

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Bibliographic Details
Published in:Endocrinology, diabetes & metabolism diabetes & metabolism, 2021-04, Vol.4 (2), p.e00207-n/a
Main Authors: Adams, Rachel, Daly, Nicole, Robertson, Elizabeth, Giordano, Giuseppe N.
Format: Article
Language:English
Subjects:
Biomarkers
Clinical Medicine
Clinical outcomes
Clinical trials
Clinical Trials as Topic - economics
Cohort Studies
Consortia
Cost of Illness
Cost Savings
Diabetes
Diabetes Mellitus, Type 2 - diagnosis
Diabetes Mellitus, Type 2 - drug therapy
Disease Progression
Endocrinology and Diabetes
Endokrinologi och diabetes
Humans
Kidney diseases
Klinisk medicin
Medical and Health Sciences
Medicin och hälsovetenskap
Monitoring, Physiologic
novel clinical trial design
Patient Reported Outcome Measures
Patients
Precision medicine
prediabetes
Prediabetic State - diagnosis
Prediabetic State - drug therapy
Regulatory approval
Research Design
Ten Minute Tutorial
Time Factors
type 2 diabetes mellitus
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Summary:Developing a novel therapeutic product for the treatment of type 2 diabetes (T2D) is a long, resource‐intensive process. Novel biomarkers could potentially aid clinical trial design by shortening clinical trials or enabling better prediction of at‐risk populations and/or disease progression. Novel clinical trial designs could lead to reduced costs of development and less burden to patients, due to shorter trial duration, and/or less burdensome assessments. This is a review of the potential use of biomarkers in novel clinical trial design. It also describes the IMI2 RHAPSODY consortium.
ISSN:2398-9238
2398-9238
DOI:10.1002/edm2.207