An observational historical cohort study to evaluate chronic disease onset associated with long-term oral corticosteroid and it’s cost impact on patients in the OPCRD / CPRD databases

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27222
• EU PAS number:
  EUPAS15175
• Study ID:
  27222
• Official title and acronym:
  An observational historical cohort study to evaluate chronic disease onset associated with long-term oral corticosteroid and it’s cost impact on patients in the OPCRD / CPRD databases
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A matched historical cohort study to determine side effects of long-term/intermittent use of oral corticosteroids (OCS) and to measure the mean time required for the onset of side effects in patients prescribed OCS.
• Study status:
  Finalised

Research institution and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 06/09/2016

Actual: 06/09/2016

Study start date

Planned: 01/11/2016

Actual: 25/11/2016

Data analysis start date

Planned: 20/12/2016

Date of interim report, if expected

Planned: 31/01/2017

Date of final study report

Planned: 29/09/2017

Actual: 31/07/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable