The UNICANCER Real World Data Group

Acquiring, enhancing and centralising existing real word data in oncology

The Epidemiological Strategy and Medical Economics (ESME) research programme aims to centralise existing real-world patient data in oncology.

ESME data platforms provide independent and high quality aggregated real life data available for analysis by the scientific and medical community, as well as to the pharmaceutical industry and health authorities.

 

In 2014, R&D UNICANCER launched the Epidemiological Strategy and Medical Economics (ESME) research programme to centralise existing real-world patient data in oncology.

ESME data platforms provide independent and high quality aggregated real life data available for analysis by the scientific and medical community (via specific calls for projects), as well as to the pharmaceutical industry and health authorities (via the provision of statistical reports).

So far, data contributors are the French Comprehensive Cancer Centres (FCCCs) network. Data modelling is under development to extrapolate ESME data to the whole French territory.

+100 multidisciplinary international and national experts already joined the ESME research programme

ESME research programmes are conceived by the UNICANCER Real World Data group, a multi-disciplinary panel of experts (oncologists, methodologists, epidemiologists, pharmacists, health economists, and biostatisticians).

 

Strategic priorities

  •  Retrospectively describe French patients cancer therapeutic management and patient characteristics
  •  Describe the current standard therapeutic strategies and treatment lines
  •  Describe reported outcomes that tend to impact the therapeutic strategies
  •  Provide data for market access filing, e.g. target population, cost-effectiveness
  •  Provide data to support Health Economic Models and requirements from Health Authorities

 

 

 

ESME Research Data Platform sources

This programme integrates data from three main sources.

 

Patient database

Patient data collected from Electronic health records (HER) containing data from unstructured sources (e.g. medical records):

  • Demographics
  • Cancer management,
  • Clinical events (progression, relapse),
  • Pathological report,
  • Metastatic disease,
  • Anti-cancer treatment (chemotherapy, targeted therapy, endocrine therapy, immunotherapy),
  • Other therapeutic care (radiotherapy, surgery)
  • Supportive care
  •  

Treatment database

Pharmacy records, describing anti-cancer treatments delivered by the FCCCs:

  • Dates,
  • Anticancer treatments,
  • Therapeutic protocol
  • Other concomitant drugs
  • Etc.

Hospitalisation database

A systematic database (French programme for medicalisation) ESME data platform (personal health data hosting)

  • Hospitalisations: dates, diagnoses, GHS code (« groupes homogènes de séjour »)
  • Medical procedures (incl. radiotherapy): dates
 

 

Areas of focus

Metastatic breast cancer data platform

  • 19,500 observations centralised into the ESME metastatic breast cancer (MBC) data platform over the past 9 years (2008-2017)
  • 30,000 observations expected by 2019
  • Data enhancement: +20 active projects research analysis selected by the Scientific Committee
  • 4th database lock planned in 2018

Ovarian cancer data platform

  • 14,000 observations expected by 2019 in the ovarian cancer data platform
  •  Patient data collected over 7 years (2013-2019)
  •  First database lock planned Q4 2017
  •  Ready for enhancement by Q2 2018

Lung cancer: the next ESME Project

The next project will cover lung cancer with the aim to build a comprehensive data platform describing the evolution of patient care (clinical and pathological features, treatment, surgery, survival criteria) in the FCCC network as well as public hospitals in France.

  •  26,000 observations expected over 7 years (2015-2021)
  •  First database period by S1 2018.
 

 

 

 

 

ESME Research Programme Initiative: governance and partnerships 

 

Transparency and independence are the key words in the ESME research programme. Any analysis request, coming from an institutional or an industrial partner, is evaluated by the Scientific Committee to ensure compliance with predefined eligibility criteria and scientific pertinence.

The ESME internal ethics committee monitors any potential conflict of interest related to experts involved in the programme. The programme is funded by a consortium of industrial partners. Contractual statistical reports are delivered to the partners and a copy is sent to the health authorities.

 

Partners

Real World Programme partners: Roche, AstraZeneca, Pfizer, Pierre Fabre

Data-exploitation partner: French National Cancer Institute (INCa)

 

The Real World Data Group in short

 

 

Contact

Head of Real World Data Department: Mathieu Robain

Scientific committee President: David Perol

For any request, please email us.