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Registry-based rand...
Registry-based randomised clinical trials : a remedy for evidence-based diabetes care?
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- Eriksson, Jan W. (författare)
- Uppsala University,Uppsala universitet,Klinisk diabetologi och metabolism
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- Eliasson, Björn (författare)
- Sahlgrens Univ Hosp, Dept Med, Gothenburg, Sweden.;Vastra Gotalandsregionen, Swedish Natl Diabet Register, Gothenburg, Sweden.,Sweden National Diabetes Register,Sahlgrenska University Hospital
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- Bennet, Louise (författare)
- Lund University,Lunds universitet,Allmänmedicin och samhällsmedicin,Forskargrupper vid Lunds universitet,Family Medicine and Community Medicine,Lund University Research Groups,Skåne University Hospital
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- Sundström, Johan, Professor, 1971- (författare)
- Uppsala University,Uppsala universitet,Klinisk epidemiologi,Univ New South Wales, George Inst Global Hlth, Sydney, NSW, Australia.,University of New South Wales
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(creator_code:org_t)
- 2022-07-29
- 2022
- Engelska.
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Ingår i: Diabetologia. - : Springer Nature. - 0012-186X .- 1432-0428. ; 65:10, s. 1575-1586
- Relaterad länk:
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Nyckelord
- Clinical outcomes
- First-line treatment
- Glucose-lowering drugs
- Healthcare registry
- Macrovascular complications
- Microvascular complications
- Mortality
- Randomised trial
- Review
- Type 2 diabetes
- Clinical outcomes
- First-line treatment
- Glucose-lowering drugs
- Healthcare registry
- Macrovascular complications
- Microvascular complications
- Mortality
- Randomised trial
- Review
- Type 2 diabetes
Publikations- och innehållstyp
- ref (ämneskategori)
- for (ämneskategori)
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