Randomised Controlled Trial (RCT) vs Real Life initiative (RCT vs Real Life)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28228
• EU PAS number:
  EUPAS7727
• Study ID:
  28228
• Official title and acronym:
  Randomised Controlled Trial (RCT) vs Real Life initiative (RCT vs Real Life)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  To determine the proportion of patients with COPD in the community who would meet inclusion/exclusion criteria of recently registered RCTs of long-acting bronchodilator therapy and to compare characteristics of COPD patients in OPCRD with those from individual RCTs
• Study status:
  Finalised

Research institution and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 17/07/2014

Study start date

Planned: 13/08/2014

Actual: 06/10/2014

Data analysis start date

Planned: 10/11/2014

Actual: 08/12/2014

Date of final study report

Planned: 15/12/2014

Actual: 11/03/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

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