Enriched RWE study in the Nordics a case study

Transcription

1 Enriched RWE study in the Nordics a case study RWD conf. Helsinki, November 28, 2018 Susanne Kihlblom, MSc Pharm., Diplom.Clin.Trials Copyright 2017 IQVIA. All rights reserved.

2 IQVIA All rights reserved.

3 Real-World Evidence in the Nordics Statisticians Consultants Project managers Programmers Data managers Epidemiologists 140+ PROFESSIONALS IN 6 COUNTRIES Denmark 1 Office: Copenhagen 8 employees Estonia 2 Offices: Tallinn, Tartu 25 employees Finland 2 Offices: Espoo (Helsinki), Turku 45 employees Poland 12 home-based resources Norway 1 Office: Oslo 1 employee Sweden 2 Offices: Solna (Stockholm), Gothenburg, home-based 45 employees IQVIA - Discussion with Sigurd Orstavik, Takeda Nordics - 4th June

4 Secondary Data Overview of Enriched Studies What are Enriched studies? Enriched studies integrate two methods of data collection to build a comprehensive patient record and increase researchable data Benefits: Longitudinal Patient Record Generate high quality, longitudinal patient data Primary Data Primary Data Primary Data Primary Data Address broader / multiple research questions Enriched patient record Optimise study design Establish approach for longerterm follow up Drive efficiency Speed to insights Primary Data Primary Data Primary Data Primary Data Primary Data 3

5 The Enriched study design Various types of data can be used in an Enriched study Completed by physicians during routine practice; containing information about healthcare utilisation Completed by physicians/delegates during studies; Containing information collected as per protocol Electronic Case Report Forms Claims data Electronic Medical Records Completed by physicians during routine practice; Containing information required by the healthcare provider for the management and administration of care Completed by patients enrolled in the study; Containing information about the patients health such as quality of life, functional status, adherence, treatment satisfaction, etc. collected as per protocol/routine practice Patient Reported Outcomes Enriched Real World Data Existing registries Previously collected uniform data; Containing data for a specified research need and population Type of primary data collection Data extracted from each source is linked at the Patient Level using unique identifiers and combined into one comprehensive data set Type of secondary data collection 4

6 Overview The Enriched of Enriched study Studies design Enriched studies are classified into models which are characterised by the type of secondary data source used Models within Enriched studies are evolving as we increase our secondary data access and continue to innovate to meet client needs EMR panel driven approach Custom EMR data extraction Claims based studies Registry based studies Primary data Secondary data Primary data Secondary data Primary data Secondary data Primary data Secondary data PRO and/or ecrf Panel EMR PRO and/or ecrf Extract. EMR PRO and/or ecrf Claims PRO and/or ecrf Registries Sites are identified and recruited through an EMR panel Sites are recruited through a traditional or a data-driven approach Sites are recruited through a traditional or a data-driven approach Sites are recruited through a traditional or a data-driven approach EMR for study patients is extracted from a database and enriched with ecrf or PRO data collections EMR is extracted from study sites for relevant patients then enriched with ecrf or PRO data collections ecrf or PRO data collections are enriched with claims data through patientlevel matching Existing registry data (national or disease specific) is enriched with ecrf or PRO data collections Model not yet demonstrated The operational methodology of an Enriched study varies depending on the type of secondary data source used and associated restrictions in data governance and physician disclosure *CRF data collection may involve other data sources, e.g. central lab data, biobank 5

7 Overview of Enriched Studies Each data source may be more effective at addressing specific study objectives or patient populations IQVIA has access to a multitude of secondary assets which can be used in addition to primary data Data types: Countries EMR US, UK, GER, FR, AUS, IT, SP, BE, CA Claims US, JP, AUS, CA, UAE Secondary Linked multisource data Existing Registries ecrf Primary PROs Nordics, FR, US TA-dependant All All Typical coverage Site-level National Site-level & National National or Regional Study specific Study specific Typical setting of care Primary care Secondary care Both (via linked data) Either (bespoke) Either (bespoke) Either (bespoke) Study Objectives Clinical outcomes / measures Adherence & persistence Adverse events Co-morbidities HCRU PROs HCRU Health care Resource Utilisation

8 Scandinavian Data - depth & longitudinal availability Electronic Medical Records (EMR) data 25 years Mortality data Patient info Rx data HOLISTIC PATIENT VIEW HCP contact Risk factors, measures Lab results. 7

9 Patient data linked through a personal identification number EMR Data hospital & primary care National Prescription Registry National Cancer Registry Pygargus Research Database Diseasespecific Registry (~100) National Patient Registry Cause of Death Registry Breast Cancer Register Melanoma Cancer Register Ovarian Cancer Register Leukemia Register Prostate Cancer Register Lung Cancer Register. 8

10 Pygargus CXP Modern extraction tool Electronic Medical Records Anonymized patient data Different health care systems. 9

11 Diabetes burden in 2017* 425 million people living with diabetes worldwide Prevalence 8.8% 50% of these people do not know they have diabetes ~80% live in low-income and middle-income countries 4 million deaths related to diabetes worldwide 46% of these deaths were in people under the age of 60 years *People aged years; data from the International Diabetes Federation Atlas, 8th edition 10

12 Increasing prevalence worldwide by 2045, 693 million people years, or 629 million of people years, will have diabetes. The largest increases will take place in regions where economies are moving from low-income to middle-income levels. International Diabetes Federation Atlas, 8th edition 11

13 Rationale of the DISCOVER study Type 2 diabetes requires comprehensive management according to guidelines to reduce the risk of complications and improve quality of life However: - in many regions, data on treatment and outcomes are scarce - where data sources are available, there is insufficient detail - few data have been captured on newer classes of glucose-lowering drugs AstraZeneca set-up the DISCOVER study programme (NCT and NCT ) to address these knowledge gaps DISCOVER will provide real world observational data on use of second- and later-line glucose-lowering therapies in people with type 2 diabetes worldwide L Ji et al. J Diabetes Complications 2017;31:

14 Study design 3-year, observational, prospective study programme* People with type 2 diabetes Initiating a second-line glucose-lowering therapy 38 countries (Denmark, Sweden and Norway are included) Recruitment 3-year follow-up Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 First patient enrolled Last patient enrolled Current status Last patient last visit *NCT and NCT in Japan. L Ji et al. J Diabetes Complications 2017;31:

15 Patients from 38 countries Europe 2002 Eastern Med. Americas 811 Africa Western Pacific Africa Algeria and South Africa Americas Argentina, Brazil, Canada, Colombia, Costa Rica, Mexico and Panama South-East Asia India and Indonesia Europe Austria, Czech Republic, Denmark, France, Italy, Netherlands, Norway, Poland, Russia, Spain, Sweden and Turkey Eastern Med. Bahrain, Egypt, Jordan, Kuwait, Lebanon, Oman, Saudi Arabia, Tunisia and United Arab Emirates South East Asia Western Pacific Australia, China, Japan, Malaysia, South Korea and Taiwan individuals from 38 countries WHO, World Health Organization, L Ji et al. J Diabetes Complications 2017;31:

16 IQVIA s data collection in study (primary cohort) EMR Sweden Denmark Norway ~ 40 primary care centres ~ 10 primary care centres ~ 20 primary care centres DA+ (Diabetes Cohort) Disease Analyzer THIN ecrf & PRO data collection DISCOVER variables DISCOVER variables DISCOVER variables National registries National registries National registries National registries No. of patients 276 patients 41 patients 79 patients 15

17 IQVIA s data collection in study (secondary Nordic cohort) EMR Sweden Denmark Norway DA+ (Diabetes Cohort) Disease Analyzer THIN ~40 Primary care centres ~ 20 primary care centres ~ 20 primary care centres Registry data National registries National registries National registries No. of patients patients patients patients 16

18 Conclusions DISCOVER global HbA 1c levels vary greatly across regions and countries, but are consistently high - This suggests that treatment intensification is delayed in many people Global burden of complications is substantial, even among individuals early in the disease process who are presumably at lower risk Large variation in complication prevalence across countries Opportunity for aggressive risk factor screening and modification at early stages of diabetes L Ji et al. J Diabetes Complications 2017;31:

19 Conclusions continued First- and second-line therapies varied across regions Metformin monotherapy at first line in 61% of participants - Metformin was discontinued in just under 20% Lack of efficacy was the main reason for treatment change The most common second-line treatment options were the addition of a sulphonylurea or DPP-4i to metformin Region was an important predictor of second-line treatment in individuals initially prescribed metformin monotherapy L Ji et al. J Diabetes Complications 2017;31:

20 Summary IQVIA has extensive experience in - Enriched RWE studies in the Nordics Including innovative & multi-country studies - Clinical trials Increasing collaboration on innovative RWE study designs within IQVIA in the Nordics Excellent base for designing and conducting innovative RWE studies, including enriched trials Center of Excellence in the Nordics 19

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22 Thank you! Questions?