Diabetes and real world evidence

Commitment to type 2 diabetes

Real world evidence (RWE) studies such as the DISCOVER study complement data from randomized clinical trials by describing disease patterns, treatments and effectiveness of treatments in the real world – essential information that will help to support the clinical decision-making process. As part of its ongoing commitment to optimizing outcomes for patients with type 2 diabetes and other chronic conditions, AstraZeneca proactively supports a comprehensive RWE study programme across the globe. RWE studies that address major clinical questions include the following.

Study Country/region Aim
Qingdao NCT01053195 China To assess the incidence and management of disorders related to type 2 diabetes
European Union treatment patterns Europe To describe drug treatment patterns in patients with type 2 diabetes (France, Italy, Spain, Netherlands and UK)
Cardiovascular risk and events Germany and Canada To assess the risk of developing cardiovascular events in patients with type 2 diabetes receiving sulphonylureas
START NCT02208921 India An observational cross-sectional study to assess the prevalence of chronic kidney disease in patients with type 2 diabetes
Clinical Practice Research Datalink (CPRD) UK A longitudinal study to assess microvascular and macrovascular complications in UK patients with type 2 diabetes
DECIDE NCT02616666 UK To assess the effectiveness of the SGLT2 inhibitor dapagliflozin in UK clinical practice
DISCOVER Global Registry NCT03549754 Worldwide A prospective, investigator-led quality improvement registry to assess patient characteristics, disease management and outcomes in adults with type 1 or type 2 diabetes.

What is real world evidence?

Real world evidence (RWE) is derived from data collected during routine clinical practice and/or patient experience. It complements evidence generated in randomized controlled trials.1

RWE provides information about:

  • disease burden and unmet medical needs
  • effectiveness, safety and cost of treatment
  • use of a treatment in representative patient populations
  • treatment pathways in everyday clinical practice.

Randomized controlled trials (traditional interventional studies) are considered to be the ‘gold standard’ for providing evidence of the efficacy and safety of a new health intervention. With randomization, other variables are on average equal between groups and any difference in outcomes can therefore be attributed to the intervention. Randomized controlled trials are, however, conducted in a predefined, restricted patient population within a controlled setting and for a limited time, which may not be representative of the intervention in a real world clinical setting (see figure).

The relationship between traditional interventional studies and the RWE approach

Figure. The relationship between traditional interventional studies and the RWE approach

In contrast, RWE studies (observational studies) draw on a wide range of data sources, including pragmatic trials, patient registries, claims databases, electronic medical records, and surveys of healthcare professionals and patients. Results of observational studies, however, should be interpreted with care, taking into account potential sources of bias (e.g. selection or recall bias and loss to follow-up) and confounding.

Through wider use of RWE, a range of stakeholders, from healthcare regulators and payers to patients, can access an evidence base for determining the clinical effectiveness and cost-effectiveness of a given treatment in a broader and more representative patient population. For example, in some countries payers use RWE to support decision-making about insurance coverage and reimbursement (see figure).

The value of RWE

Figure. Value of RWE to different stakeholders and decision-makers. Reproduced with permission from Nason and Husereau, 2014.2

AstraZeneca is committed to ensuring that patients and their healthcare providers have the most robust information possible to support decisions regarding treatment and is proactively seeking to increase access to RWE. AstraZeneca does this through collaboration with specialists to collect and analyse real world data (e.g. the Diabetes Collaborative Registry and with patient organizations such as PatientsLikeMe).

References

  1. Garrison LP et al. Value Health 2007;10:326–35.
  2. Nason E, Husereau D. Roundtable on real world evidence. 2014. http://www.ihe.ca/research-programs/knowledge-transfer-dissemination/roundtables/real-world-evidence/about-rwe. Accessed April 2016

Diabetes Collaborative Registry

The Diabetes Collaborative Registry (DCR) is the first cross-speciality clinical registry designed to track and improve the quality of diabetes and metabolic care in primary and speciality care settings in the USA.

The DCR is an interdisciplinary initiative led by the American College of Cardiology (ACC) in partnership with the American Diabetes Association (ADA), the American College of Physicians (ACP), the American Association of Clinical Endocrinologists (AACE) and the Joslin Diabetes Center (Boston, MA, USA).

The registry brings together real world, data-rich, clinical assets from multiple healthcare specialities. Studies using the DCR will provide information from the USA that will complement the results of the DISCOVER study in other countries.

The Diabetes Collaborative Registry

Figure. The Diabetes Collaborative Registry is a working partnership between multiple healthcare providers

The DCR provides a unique, longitudinal view of the presentation, progression, management and outcomes of patients with diabetes as they receive care and treatment from multidisciplinary care teams. AstraZeneca is the founding sponsor of the DCR.

For more information about the DCR, please visit their website: http://www.ncdr.com/WebNCDR/Diabetes/publicpage.

Commitment to type 2 diabetes

Real world evidence (RWE) studies such as the DISCOVER study complement data from randomized clinical trials by describing disease patterns, treatments and effectiveness of treatments in the real world – essential information that will help to support the clinical decision-making process. As part of its ongoing commitment to optimizing outcomes for patients with type 2 diabetes and other chronic conditions, AstraZeneca proactively supports a comprehensive RWE study programme across the globe. RWE studies that address major clinical questions include the following.

Qingdao NCT01053195
Country/region: China
Aim: To assess the incidence and management of disorders related to type 2 diabetes
European Union treatment patterns
Country/region: Europe
Aim: To describe drug treatment patterns in patients with type 2 diabetes (France, Italy, Spain, Netherlands and UK)
Cardiovascular risk and events
Country/region: Germany and Canada
Aim: To assess the risk of developing cardiovascular events in patients with type 2 diabetes receiving sulphonylureas
START NCT02208921
Country/region: India
Aim: An observational cross-sectional study to assess the prevalence of chronic kidney disease in patients with type 2 diabetes
Clinical Practice Research Datalink (CPRD)
Country/region: UK
Aim: A longitudinal study to assess microvascular and macrovascular complications in UK patients with type 2 diabetes
DECIDE NCT02616666
Country/region: UK
Aim: To assess the effectiveness of the SGLT2 inhibitor dapagliflozin in UK clinical practice
DISCOVER Global Registry NCT03549754
Country/region: Worldwide
Aim: A prospective, investigator-led quality improvement registry to assess patient characteristics, disease management and outcomes in adults with type 1 or type 2 diabetes.

What is real world evidence?

Real world evidence (RWE) is derived from data collected during routine clinical practice and/or patient experience. It complements evidence generated in randomized controlled trials.1

RWE provides information about:

  • disease burden and unmet medical needs
  • effectiveness, safety and cost of treatment
  • use of a treatment in representative patient populations
  • treatment pathways in everyday clinical practice.

Randomized controlled trials (traditional interventional studies) are considered to be the ‘gold standard’ for providing evidence of the efficacy and safety of a new health intervention. With randomization, other variables are on average equal between groups and any difference in outcomes can therefore be attributed to the intervention. Randomized controlled trials are, however, conducted in a predefined, restricted patient population within a controlled setting and for a limited time, which may not be representative of the intervention in a real world clinical setting (see figure).

The relationship between traditional interventional studies and the RWE approach

Figure. The relationship between traditional interventional studies and the RWE approach

In contrast, RWE studies (observational studies) draw on a wide range of data sources, including pragmatic trials, patient registries, claims databases, electronic medical records, and surveys of healthcare professionals and patients. Results of observational studies, however, should be interpreted with care, taking into account potential sources of bias (e.g. selection or recall bias and loss to follow-up) and confounding.

Through wider use of RWE, a range of stakeholders, from healthcare regulators and payers to patients, can access an evidence base for determining the clinical effectiveness and cost-effectiveness of a given treatment in a broader and more representative patient population. For example, in some countries payers use RWE to support decision-making about insurance coverage and reimbursement (see figure).

The value of RWE

Figure. Value of RWE to different stakeholders and decision-makers. Reproduced with permission from Nason and Husereau, 2014.2

AstraZeneca is committed to ensuring that patients and their healthcare providers have the most robust information possible to support decisions regarding treatment and is proactively seeking to increase access to RWE. AstraZeneca does this through collaboration with specialists to collect and analyse real world data (e.g. the Diabetes Collaborative Registry and with patient organizations such as PatientsLikeMe).

References

  1. Garrison LP et al. Value Health 2007;10:326–35.
  2. Nason E, Husereau D. Roundtable on real world evidence. 2014. http://www.ihe.ca/research-programs/knowledge-transfer-dissemination/roundtables/real-world-evidence/about-rwe.

Diabetes Collaborative Registry

diabetes-collaborative-registry-logo

The Diabetes Collaborative Registry (DCR) is the first cross-speciality clinical registry designed to track and improve the quality of diabetes and metabolic care in primary and speciality care settings in the USA.

The DCR is an interdisciplinary initiative led by the American College of Cardiology (ACC) in partnership with the American Diabetes Association (ADA), the American College of Physicians (ACP), the American Association of Clinical Endocrinologists (AACE) and the Joslin Diabetes Center (Boston, MA, USA).

The registry brings together real world, data-rich, clinical assets from multiple healthcare specialities. Studies using the DCR will provide information from the USA that will complement the results of the DISCOVER study in other countries.

The-Diabetes-Collaborative-Registry

Figure: The Diabetes Collaborative Registry is a working partnership between multiple healthcare providers

The DCR provides a unique, longitudinal view of the presentation, progression, management and outcomes of patients with diabetes as they receive care and treatment from multidisciplinary care teams. AstraZeneca is the founding sponsor of the DCR.

For more information about the DCR, please visit their website: http://www.ncdr.com/WebNCDR/Diabetes/publicpage.