Electronic Healthcare Databases and Pharmaco-Epidemiology (unpaid position)

Promotor: 
frank.de.vries@mumc.nl
About the supervisors: 
Dr. Frank de Vries started a PhD in pharmacoepidemiology at Utrecht University in 2002 on side effects of use of inhaled corticosteroids. Since then, he has worked for the Medicine and Healthcare products Regulatory Agency. He has obtained several research grants and prizes, including the Swierenga award for respiratory disease, an 'NWO Veni' fellowship and the Kohn prize from the UK National Osteoporosis Foundation. His work has been published in various journals including JAMA, the NEJM & BMJ.
 
He currently works as a hospital pharmacist in the Maastricht University Medical Centre+. He is a member of the Clinical Epidemiology program at School CAPHRI in Maastricht and is on secondmend at the Utrecht Institute for Pharmaceutical Sciences, The Netherlands. He is a visiting scientist at the MRC Lifecourse Epidemiology Unit in Southampton, UK.
 
Research activities mainly focus on patients with respiratory disease, cardiovascular disease and movement disorders.
About the research group: 

The group is comprised of 6-8 postdocs and 10-15 PhD students. We have an inhouse statistician and can provide supervision in data management, programming and scientific writing. Our group has access to the world's largest electronic healthcare databases and registries such as the UK clinical practice research datalink (n=15 million), the full country of Denmark (n=5.5 million) and the PHARMO Record Linkage System. A list of publications can be found here.

 

All (former) PhD students are currently employed at pharmaceutical companies, academia, drug regulators, health insurance institutions, hospitals or pharmacies.

Work field of the proposed project: 
Pharmaco-epidemiology
Estimated duration: 
3 year
Scientific background: 

Pharmacoepidemiology studies the use of drugs and their effects in large numbers of people after market authorization.  It overcomes limitations from premarketing randomised clinical drug trials (RCTs), which are not representative of patients in real life clinical care, and which do not allow studying rare (with frequencies ≥0.1%) or long-term severe side effects. Typical pharmaco-epidemiological studies use advanced epidemiological methods to study large electronic healthcare databases (EHDs) with medical records of millions of patients for effectiveness and safety of drugs. Regulatory authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) assess the risk/benefit balance of medicines to decide whether their market authorisation may be restricted or completely withdrawn. Regulatory review is supported by evidence from clinical trials and pharmacoepidemiological studies that are either published, conducted voluntary or upon the regulator´s request by manufacturers of medicines (post-authorisation safety studies [PASS]). A PASS is defined in EU Directive 2001/83/EC. PASS studies will then be assessed by the EMA’s Pharmacovigilance Risk Assessment Committee , which recommends on the maintenance of the terms of the marketing authorization. This is then forwarded to the Committee for Medicinal Products for Human Use for final decision making.

Main research question, subquestions and aim(s): 

With access to billions of medical and prescribing / dispensing records, we can address billions of research questions. To prospective students who bring their own funding, we are quit flexible to discuss details and personal goals.

Research design and methods: 

Cohort studies, time-varying Cox regression analysis and occasionally case-control and drug utilization studies.

Research activities: 

Manuscript writing, statistical programming, SAS programming, medical literature review, study design. We expect you to regularly join our journal club and provide supervision / teaching activities to other students (MSc and PhD). In contrast to most other PhD projects, our data is readily available and you can start analysing from the first day in the office, should a study protocol already have been approved.

Expected results: 

A full PhD thesis with 6-8 original scientific articles, a general introduction and a discussion. According to recent interviews with epidemiology executives at large pharmaceutical companies, contract research organisations and regulators, this training will make you perfectly suited for a role in their departments.

Time schedule and publication plan: 
Period Activity
   
   
   
   
   

Previous PhD students had completed their thesis within 1.5 - 5 years. We offer an environment in which 1.5 years is possible, should you have the right skills and attitude.

Competences the applicant needs to have or acquire for the project: 

Requirements:

1. A strong foundation in epidemiology.

2. English writing, reading and speaking skills (CFER C1+ level or equivalent).

3. A background in medicine, pharmacy, epidemiology, statistics, economics or health informatics.

Preferred

1. Medical Doctor or Pharmacist by training

2. Computer programming skills, preferably SAS

 

 

Internal contact: 
frank.de.vries@mumc.nl