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The UK contribution to Real World Research: Review of published data at ISPOR, Madrid 2011 Kate Peperell 1 , Rick Lones 2 , Nancy Devlin 3 on behalf of the ABPI RWD Campaign Team 1. Director, pH Associates, Marlow 2. Executive Medical Director , UK & Ireland, Bristol-Meyers Squibb 3. Director of Research, Office of Health Economics Introduction Real World Data (RWD) is becoming increasingly important in decisions that affect patients’ access to medicines. The vast majority of pharmaceutical companies based in the UK are actively involved in generating or using RWD to inform HTA of their products 1 . The UK is considered as an advantageous environment for the conduct of real world health care studies 2 due to : The UK health technology assessment (HTA) processes which have a global impact on healthcare decision making The unique cradle-to-grave health care provided by the UK NHS The many existing NHS healthcare databases and disease registries, including CPRD which is considered one of the “gold standard clinical data sources in the world. The Association of British Pharmaceutical Industries (ABPI) through its RWD Campaign Team are working to support the UK research environment to become a centre of excellence and more attractive for RW Research. In order to establish an indicator of the current influence of the UK in global RW research a review of all abstracts presented at ISPOR 2011 was undertaken. Methods All abstracts presented at the ISPOR 14 th Annual European Congress in Madrid, Spain in 2011 were reviewed by a single researcher by searching the ISPOR OUTCOMES RESEARCH DIGEST (http://www.ispor.org/research_study_digest/index.asp). Abstracts reporting RW data were classified according to: therapeutic area, type of study, setting, source of data and methodology, country where undertaken, country of authors and involvement of commercial sponsors. Conclusions: RW studies presented at the ISPOR European Congress 2011 were most often undertaken in a single country and involved a database study design The USA is the most prolific source of RW studies Of the rest, the UK was the source of RW data in twice as many studies as any other country, lending weight to the opinion that the UK provides an excellent environment for conducting RW studies. As the demand for Real World Research continues to grow, the UK has the opportunity to play a leading role in terms of the provision of RW data and the conduct of research Presented at the ISPOR 15 th Annual European Congress, Berlin 3 rd -7 th Nov 2012. Abstract no. PRM6 References: 1. The collection and use of real world data: Results from a 2009 survey of British Pharmaceutical companies. Poster present at ISPOR Annual European Congress 2010 2. The Vision for Real World Data Harnessing the Opportunities in the UK. ABPI White Paper September 2011 Results Figure 2: Countries providing data for RW studies A total of 1455 abstracts were reviewed. 278 abstracts describing RW studies were identified. Figure 1: Proportion of ISPOR abstracts 2011 describing RW studies Real World research 19.1% Other research 80.9% Figure 5: Types of centres where RW studies were conducted Local service evaluation 0.4% Prospective study 18.0% Retrospective & prospective study 1.1% Retrospective study 79.1% Systematic review 1.4% Figure 4: Types of RW studies conducted 0.7% 0.4% 35.6% 0.4% 1.1% 1.1% 0.4% 47.5% 0.7% 6.1% 2.2% 2.9% 1.1% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% % of RW studies 0.7% 55.8% 5.8% 19.1% 0.7% 1.4% 15.8% 0.4% 0.4% 0% 10% 20% 30% 40% 50% 60% % of RW studies Figure 3: Data sources used for RW studies Figure 6: Proportion of RW studies with a financial sponsor Figure 8: Location of RW studies with UK authorship 4 7 143 64 33 19 1 5 2 0 20 40 60 80 100 120 140 160 UK International (including UK) International (non UK) Other country (non UK) US Number of RW studies UK author No UK author 79% of all RW studies were retrospective in design 89% of all RW studies were undertaken in a single country 12% of all RW studies were conducted in the UK A further 8% of studies included UK centres in an international study No financial sponsor 28.8% Non commercial sponsor 6.8% Commercial sponsor 64.4% All studies No financial sponsor 15.0% Non commercial sponsor 6.7% Commercial sponsor 78.3% All studies including a UK author N=1455 Descriptive studies 34.9% Comparative studies 65.1% N=278 N=278 N=278 N=60 USA 24% UK 12% Spain 6% Canada 5% Germany 5% France 5% Netherlands 3% Italy 3% Other 26% International 11% N=278 Figure 7: UK authorship of RW study abstracts Includes UK author 21.6% No UK author 78.4% N=278 N=278 N=278 N=278 56% of all RW studies used databases as their data source, 19% patient medical records and 16% surveys or questionnaires 36% of all RW studies were described as conducted in a hospital setting and a further 48% as multicentre studies 85% of RW studies including a UK author had a financial sponsor compared to 71% of all RW studies All UK conducted studies and 83% of international studies (including UK data) included a UK author

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Page 1: The UK contribution to Real World Research: Review of .... ABPI_ISPO… · Presented at the ISPOR 15th Annual European Congress, Berlin 3rd-7th Nov 2012. Abstract no. PRM6 References:

The UK contribution to Real World Research: Review of published data at ISPOR, Madrid 2011

Kate Peperell1, Rick Lones2, Nancy Devlin3 on behalf of the ABPI RWD Campaign Team 1. Director, pH Associates, Marlow 2. Executive Medical Director , UK & Ireland, Bristol-Meyers Squibb 3. Director of Research, Office of Health Economics

Introduction

Real World Data (RWD) is becoming increasingly important in decisions that affect patients’ access to medicines.

The vast majority of pharmaceutical companies based in the UK are actively involved in generating or using RWD to inform HTA of their products1.

The UK is considered as an advantageous environment for the conduct of real world health care studies 2 due to :

The UK health technology assessment (HTA) processes which have a global impact on healthcare decision making

The unique cradle-to-grave health care provided by the UK NHS

The many existing NHS healthcare databases and disease registries, including CPRD which is considered one of the “gold standard “ clinical data sources in the world.

The Association of British Pharmaceutical Industries (ABPI) through its RWD Campaign Team are working to support the UK research environment to become a centre of excellence and more attractive for RW Research.

In order to establish an indicator of the current influence of the UK in global RW research a review of all abstracts presented at ISPOR 2011 was undertaken.

Methods

All abstracts presented at the ISPOR 14th Annual European Congress in Madrid, Spain in 2011 were reviewed by a single researcher by searching the ISPOR OUTCOMES RESEARCH DIGEST (http://www.ispor.org/research_study_digest/index.asp).

Abstracts reporting RW data were classified according to: therapeutic area, type of study, setting, source of data and methodology, country where undertaken, country of authors and involvement of commercial sponsors.

Conclusions:

• RW studies presented at the ISPOR European Congress 2011 were most often undertaken in a single country and involved a database study design

• The USA is the most prolific source of RW studies

• Of the rest, the UK was the source of RW data in twice as many studies as any other country, lending weight to the opinion that the UK provides an excellent environment for conducting RW studies.

• As the demand for Real World Research continues to grow, the UK has the opportunity to play a leading role in terms of the provision of RW data and the conduct of research

Presented at the ISPOR 15th Annual European Congress, Berlin 3rd-7th Nov 2012.

Abstract no. PRM6

References:

1. The collection and use of real world data: Results from a 2009 survey of British Pharmaceutical companies. Poster present at ISPOR Annual European Congress 2010

2. The Vision for Real World Data – Harnessing the Opportunities in the UK. ABPI White Paper September 2011

Results

Figure 2: Countries providing data for RW studies

A total of 1455 abstracts were reviewed.

278 abstracts describing RW studies were identified.

Figure 1: Proportion of ISPOR abstracts 2011 describing RW studies Real World

research 19.1%

Other research

80.9%

Figure 5: Types of centres where RW studies were conducted

Local service evaluation

0.4%

Prospective study 18.0%

Retrospective & prospective

study 1.1%

Retrospective study 79.1%

Systematic review 1.4%

Figure 4: Types of RW studies conducted

0.7% 0.4%

35.6%

0.4% 1.1% 1.1% 0.4%

47.5%

0.7%

6.1% 2.2% 2.9%

1.1% 0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

% o

f R

W s

tud

ies

0.7%

55.8%

5.8%

19.1%

0.7% 1.4%

15.8%

0.4% 0.4% 0%

10%

20%

30%

40%

50%

60%

% o

f R

W s

tud

ies

Figure 3: Data sources used for RW studies

Figure 6: Proportion of RW studies with a financial sponsor

Figure 8: Location of RW studies with UK authorship

4 7

143

64

33 19 1

5

2

0

20

40

60

80

100

120

140

160

UK International (including UK)

International (non UK)

Other country (non UK)

US

Nu

mb

er

of

RW

stu

die

s

UK author

No UK author

79% of all RW studies were retrospective in design

• 89% of all RW studies were undertaken in a single country • 12% of all RW studies were conducted in the UK • A further 8% of studies included UK centres in an international study

No financial sponsor 28.8%

Non commercial

sponsor 6.8%

Commercial sponsor 64.4%

All studies No financial

sponsor 15.0%

Non commercial

sponsor 6.7%

Commercial sponsor 78.3%

All studies including a UK author

N=1455

Descriptive studies 34.9%

Comparative studies 65.1%

N=278 N=278

N=278 N=60

USA 24%

UK 12%

Spain 6% Canada

5%

Germany 5%

France 5%

Netherlands 3%

Italy 3%

Other 26%

International 11%

N=278

Figure 7: UK authorship of RW study abstracts

Includes UK author 21.6%

No UK author 78.4%

N=278

N=278

N=278

N=278

56% of all RW studies used databases as their data source, 19% patient medical records and 16% surveys or questionnaires

36% of all RW studies were described as conducted in a hospital setting and a further 48% as multicentre studies

85% of RW studies including a UK author had a financial sponsor compared to 71% of all RW studies

All UK conducted studies and 83% of international studies (including UK data) included a UK author