Intensive Monitoring in Portugal: a Model to Assess Medicines in Real-Life Conditions. Antidiabetics as example. (MOMI)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/8434
• EU PAS number:
  EUPAS8433
• Study ID:
  8434
• Official title and acronym:
  Intensive Monitoring in Portugal: a Model to Assess Medicines in Real-Life Conditions. Antidiabetics as example. (MOMI)
• DARWIN EU® study:
  No
• Study countries:
  Portugal
• Study description:
  Aiming to fill the gap between clinical trials, database studies and spontaneous reporting data, an intensive monitoring model – that can monitor selected drugs over time - is proposed to be implemented in Portugal. By pharmacy based tracking of patients and drug usage in a life-cycle based fashion, this model is actively focused on gathering post-authorization data, mainly safety, since the first day of drug use. In what concerns to methods, a database comprising 3 different sources: 1) baseline subject-reported demographics and health characteristics to be administered by the community pharmacy, 2) telephone follow-up questionnaires on subject-reported risk (adverse events), (proxy of)benefit (e.g. EQ5D) and pattern of use data to be administered by the research team of the project (pharmacists) and, 3) pharmacy records was developed. All treatment naïve patients initiating treatment (inception cohort) with DPP-4, GLP-1 and SGLT2 visiting one of the participant pharmacies will be invited and to give consent to participate in the study. This is an academic project (Carla Torre’s PhD project) from the Faculty of Pharmacy of the University of Lisbon under the supervision of Prof. dr. Ana Paula Martins (Faculty of Pharmacy of the University of Lisbon) and of Prof. dr. Hubert G. Leufkens (Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht University). This study is being conducted at the Centre for Health and Research (CEFAR), an ENCePP centre - that belongs to the Portuguese National Association of Pharmacies.According to the Portuguese legislation (Law no. 67/98, 26th October), this study was submitted and approved by the Portuguese Data Protection Authority (CNPD). The study was approved by the ethics committee of the Institute of Public Health of the University of Porto.
• Study status:
  Ongoing

Research institutions and networks

Institutions

National Association of Pharmacies Portugal (ANF)

Portugal

Study timelines

Date when funding contract was signed

Planned: 30/01/2012

Study start date

Planned: 10/11/2014

Actual: 10/11/2014

Data analysis start date

Planned: 15/04/2015

Date of interim report, if expected

Planned: 01/06/2015

Date of final study report

Planned: 31/12/2016

Sources of funding

Other

More details on funding

CEFAR (CEFAR (Centre for Health Research & Evaluation) - National association of Pharmacies

Regulatory

• Was the study required by a regulatory body?:
  No