Impact of single tablet regimens on adherence and prescription errors? How big an issue and how relevant in both clinical and economic terms (iSTRAP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19193
• EU PAS number:
  EUPAS5440
• Study ID:
  19193
• Official title and acronym:
  Impact of single tablet regimens on adherence and prescription errors? How big an issue and how relevant in both clinical and economic terms (iSTRAP)
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Portugal

  Spain

  United Kingdom
• Study description:
  The aim of this international retrospective study is to evaluate the potential benefits of STR in enhancing adherence, and its clinical and economic consequences in the European context. The study also aims at quantifying prescription errors and identifying those that can be avoided by the use of STRs.
• Study status:
  Finalised

Research institutions and networks

Institutions

INMI "Lazzoro Spallanzani"

Universta di Torino Turin, Hospital Ramón y Cajal Madrid, Hospital Universitario de la Princesa (HULP) Madrid, Hospital del Mar Barcelona, Hospital do Barlavento Algarvio Faro, Centro Hospitalar de Setúbal Setubal, St. Georges Hospital London, Queen Elizabeth Hospital Birmingham, National Institute for Infectious Diseases 'L. Spallanzani' Rome

Study timelines

Date when funding contract was signed

Planned: 09/09/2013

Actual: 09/09/2013

Study start date

Planned: 01/09/2014

Actual: 13/02/2015

Date of final study report

Planned: 02/03/2015

Actual: 07/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences International Ltd

Study protocol

Initial protocol

iSTRAP GS-EU-264-1271_final_16May14

Regulatory

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