Registry-based randomised clinical trials: a remedy for evidence-based diabetes care?
| العنوان: | Registry-based randomised clinical trials: a remedy for evidence-based diabetes care? |
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| المؤلفون: | Jan W. Eriksson, Björn Eliasson, Louise Bennet, Johan Sundström |
| المصدر: | Diabetologia. 65:1575-1586 |
| بيانات النشر: | Springer Science and Business Media LLC, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Randomised trial, Microvascular complications, Endocrinology, Diabetes and Metabolism, First-line treatment, Type 2 diabetes, Review, Endocrinology and Diabetes, Diabetes Mellitus, Type 2, Clinical outcomes, Endokrinologi och diabetes, Internal Medicine, Humans, Hypoglycemic Agents, Registries, Glucose-lowering drugs, Healthcare registry, Mortality, Macrovascular complications |
| الوصف: | 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. Graphical abstract |
| وصف الملف: | application/pdf |
| تدمد: | 1432-0428 0012-186X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::07795f466245602230e3214e0f5758adTest https://doi.org/10.1007/s00125-022-05762-xTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....07795f466245602230e3214e0f5758ad |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14320428 0012186X |
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