Registry-based randomised clinical trials : a remedy for evidence-based diabetes care?
Eriksson, Jan W. ; Eliasson, Björn ; Bennet, Louise LU
and Sundström, Johan
(2022)
In Diabetologia
65(10).
p.1575-1586
- Abstract
This narrative review describes a new approach to navigation in a challenging landscape of clinical drug development in diabetes. Successful outcome studies in recent years have led to new indications and guidelines in type 2 diabetes, yet the number of clinical trials in diabetes is now declining. This is due to many environmental factors acting in concert, including the prioritisation of funding for other diseases, high costs of large randomised clinical trials, increase in regulatory requirements and limited entry of novel candidate drugs. There is a need for novel and cost-effective paradigms of clinical development to meet these and other challenges. The concept of registry-based randomised clinical trials (RRCTs) is an attractive... (More)
This narrative review describes a new approach to navigation in a challenging landscape of clinical drug development in diabetes. Successful outcome studies in recent years have led to new indications and guidelines in type 2 diabetes, yet the number of clinical trials in diabetes is now declining. This is due to many environmental factors acting in concert, including the prioritisation of funding for other diseases, high costs of large randomised clinical trials, increase in regulatory requirements and limited entry of novel candidate drugs. There is a need for novel and cost-effective paradigms of clinical development to meet these and other challenges. The concept of registry-based randomised clinical trials (RRCTs) is an attractive option. In this review we focus on type 2 diabetes and the prevention of cardiovascular and microvascular comorbidities and mortality, using the Swedish SMARTEST trial as an example of an RRCT. We also give some examples from other disease areas. The RRCT concept is a novel, cost-effective and scientifically sound approach for conducting large-scale diabetes trials in a real-world setting.
(Less)
- author
- Eriksson, Jan W.
; Eliasson, Björn
; Bennet, Louise
LU
and Sundström, Johan
- organization
- publishing date
- 2022
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Clinical outcomes, First-line treatment, Glucose-lowering drugs, Healthcare registry, Macrovascular complications, Microvascular complications, Mortality, Randomised trial, Review, Type 2 diabetes
- in
- Diabetologia
- volume
- 65
- issue
- 10
- pages
- 1575 - 1586
- publisher
- Springer
- external identifiers
-
- scopus:85135277127
- pmid:35902386
- ISSN
- 0012-186X
- DOI
- 10.1007/s00125-022-05762-x
- language
- English
- LU publication?
- yes
- additional info
- Funding Information: Open access funding provided by Uppsala University. The authors’ research in this field is supported by the Swedish Research Council (project KBF-2018-00904), a Linné grant to Lund University Diabetes Centre (LUDC 349-2006-237), EXODIAB, the Swedish Foundation for Strategic Research (LUDC IRC15-0067), Vinnova (the Swedish innovation agency), the Swedish Heart Lung Foundation (project 2019-0403) and ALF grants (government research support for university-affiliated healthcare organisations). Publisher Copyright: © 2022, The Author(s).
- id
- 9aa1ba75-ead5-412b-8059-d4bc6bda2229
- date added to LUP
- 2022-09-01 17:53:26
- date last changed
- 2024-06-10 23:03:34
@article{9aa1ba75-ead5-412b-8059-d4bc6bda2229,
abstract = {{<p>This narrative review describes a new approach to navigation in a challenging landscape of clinical drug development in diabetes. Successful outcome studies in recent years have led to new indications and guidelines in type 2 diabetes, yet the number of clinical trials in diabetes is now declining. This is due to many environmental factors acting in concert, including the prioritisation of funding for other diseases, high costs of large randomised clinical trials, increase in regulatory requirements and limited entry of novel candidate drugs. There is a need for novel and cost-effective paradigms of clinical development to meet these and other challenges. The concept of registry-based randomised clinical trials (RRCTs) is an attractive option. In this review we focus on type 2 diabetes and the prevention of cardiovascular and microvascular comorbidities and mortality, using the Swedish SMARTEST trial as an example of an RRCT. We also give some examples from other disease areas. The RRCT concept is a novel, cost-effective and scientifically sound approach for conducting large-scale diabetes trials in a real-world setting.<br/></p>}},
author = {{Eriksson, Jan W. and Eliasson, Björn and Bennet, Louise and Sundström, Johan}},
issn = {{0012-186X}},
keywords = {{Clinical outcomes; First-line treatment; Glucose-lowering drugs; Healthcare registry; Macrovascular complications; Microvascular complications; Mortality; Randomised trial; Review; Type 2 diabetes}},
language = {{eng}},
number = {{10}},
pages = {{1575--1586}},
publisher = {{Springer}},
series = {{Diabetologia}},
title = {{Registry-based randomised clinical trials : a remedy for evidence-based diabetes care?}},
url = {{http://dx.doi.org/10.1007/s00125-022-05762-x}},
doi = {{10.1007/s00125-022-05762-x}},
volume = {{65}},
year = {{2022}},
}