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Registry-based randomised clinical trials: a remedy for evidence-based diabetes care?

Jan W Eriksson1, Björn Eliasson2,3, Louise Bennet4,5

  • 1Department of Medical Sciences, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden. jan.eriksson@medsci.uu.se.

Diabetologia
|July 28, 2022
PubMed

Insights

Registry-based randomized clinical trials (RRCTs) offer a novel, cost-effective solution for conducting large-scale diabetes research. This approach addresses declining clinical trial numbers and aims to improve outcomes for type 2 diabetes and its comorbidities.

Area of Science:

  • Endocrinology and Metabolism
  • Clinical Trial Design
  • Pharmacoeconomics

Background:

  • Clinical drug development in diabetes faces challenges, including declining trial numbers due to funding shifts, high costs, and regulatory hurdles.
  • Despite recent advances, novel and cost-effective clinical development paradigms are needed to sustain research in type 2 diabetes.

Purpose of the Study:

  • To introduce and evaluate registry-based randomized clinical trials (RRCTs) as a viable approach for diabetes clinical development.
  • To highlight the potential of RRCTs in addressing challenges in conducting large-scale trials for type 2 diabetes and its comorbidities.

Main Methods:

  • Narrative review of clinical drug development in diabetes.
  • Focus on registry-based randomized clinical trials (RRCTs) using the Swedish SMARTEST trial as a case study.
  • Exploration of RRCTs for cardiovascular and microvascular comorbidity prevention in type 2 diabetes.

Main Results:

  • Registry-based randomized clinical trials (RRCTs) present an attractive, cost-effective, and scientifically sound alternative for large-scale diabetes trials.
  • The SMARTEST trial exemplifies the successful implementation of RRCTs in a real-world setting.
  • RRCTs can facilitate research in type 2 diabetes and the prevention of associated complications.

Conclusions:

  • Registry-based randomized clinical trials (RRCTs) offer a promising paradigm for future diabetes research.
  • This innovative approach can overcome current limitations in clinical trial funding and execution.
  • RRCTs are essential for advancing the understanding and management of type 2 diabetes and its complications.
Keywords:
Clinical outcomesFirst-line treatmentGlucose-lowering drugsHealthcare registryMacrovascular complicationsMicrovascular complicationsMortalityRandomised trialReviewType 2 diabetes

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