Last updated on: 16/07/2021
Name of organisation
1) Department/Research groupPharmacoepidemiology & Risk Management
2) Organisation/affiliationRTI Health Solutions
Short Name in the inventoryRTI-HS
Administrative Contact
Title Ms
Last name Franzoni Grau
First name Carla
Address line 1Av. Diagonal, 605, 9-1
Address line 2
Address line 3
CityBarcelona
Postcode08028
CountrySpain
Phone number (incl. country code)34932417776
Alternative phone number
Fax number (incl. country code)34937608507
Scientific Contact
Title Dr
Last name Perez-Gutthann
First name Susana
Address line 1Av. Diagonal, 605, 9-1
Address line 2
Address line 3
CityBarcelona
Postcode08028
CountrySpain
Phone number (incl. country code)34932417760
Alternative phone number
Fax number (incl. country code)34937608507
Alternative Scientific Contact
Title Dr
Last name Arana
First name Alejandro
Address line 1Av. Diagonal, 605, 9-1
Address line 2
Address line 3
CityBarcelona
Postcode08028
CountrySpain
Phone number (incl. country code)34-93 362 2805
Alternative phone number
Fax number (incl. country code)34937608507
2. Description
RTI is an independent non-for-profit research institute with over sixty-year history of leading research for public and private organizations. The RTI Health Solutions unit (RTI-HS) is focused on pharmaceutical and health research including pharmacoepidemiology, risk management, benefit-risk evaluation, pharmacovigilance, patient reported outcomes, health preference assessment and other. The experts in these areas are based in Europe and the U.S.
Link to RTI-HS publications list: www.rtihs.org/publications
3. Category
Charity or non-profit organisation
4. Available resources
In houseVia Contacts/Network
Epidemiologist/Pharmacoepidemiologist
Yes
No
Statistician
Yes
No
Clinician
Yes
No
Clinical Pharmacologist
Yes
No
Pharmacist
Yes
No
Geneticist/Pharmacogeneticist
Yes
No
IT specialist
Yes
No
Ethics expertise
Yes
No
Legal expertise
Yes
No
Regulatory expertise
No
Yes
Patient & HCP surveys and patient reported outcomes
Yes
No
Health Preference assessment
Yes
No
5. Therapeutic/disease areas of research in drug safety/risk-benefit performed in the past 5 years
Cardiovascular diseases
Congenital Malformations
Devices
Disorders of the central nervous system
Endocrine disorders
Eye disorders
Gastrointestinal tract
Geriatrics
Gynaecology
Immunological products and vaccines
Immunosuppression
Infectious diseases
Liver disease
Malignant disease
Musculoskeletal and joint diseases
Nutrition and blood
Osteoporosis
Paediatrics
Pregnancy
Psychiatry
Renal impairment
Respiratory diseases
Skin disorders
Urinary tract disorders
6. Design of drug safety/risk-benefit studies published in the past 5 years
Cohort Study
Case Control Study
Drug Utilisation
Meta-Analysis
Risk minimization evaluation surveys and patient, HCP & other preference assessment studies
Case-surveillance studies & quantitative risk-benefit evaluations (BRAT, now UMBRA: Unified Methodologies for Benefit-Risk Assessment)
7. Experience in collecting data directly from individual patients/respondents
Number of Studies
Greater than 5
Number of patients/respondents involved in the study(ies)
Between 150 and 1499
Between 1500 and 14999
Greater than 15000
8. Access to data collection resources
Capacity to conduct face-to-face interviews
Yes
In a clinic
Yes
In the community
Yes
Electronic data capture systems
Yes
System used:
System selected for each study
Interactive voice response systems
No
Call centre
No
9. Experience in secondary research and meta-analysis
Yes
10. Work with existing data resources in the past 3 years
Name of data resourceNo. of studies
CPRD/THIN, ISD Memo, UK22
Regions of Catalonia and Aragón, Spain5
PHARMO Institute for Drug Outcomes Research, Netherlands10
National Registries Nordic Countries, Denmark, Sweden20
GePaRD11
11. Registries established by centre
Drug RegistryDrug class = osteoporosis (US), Drug class = IBS treatment (US) (Closed)
Disease RegistryDisease area = individuals attempting to quit smoking (in EU, Canada, and US) (Closed)
Other Osteosarcoma cases who had been exposed to a specific medication in Norway, Denmark, Sweden, Finland, US (Closed)
12. Experience in collaboration in a study team
Principal Investigator
Collaborating Investigator
13. Current involvement in research networks
Networks registered with ENCePP
SIGMA
VAC4EU
14. Interest in research opportunities which are funded
By pharmaceutical companies
By charities
By government
By research councils
By EU funding schemes
15. Interest in contract research only if free to publish results
Yes
16. Selected publications of the last 5 calendar years
ReferenceLink to web-publication
Rebordosa C. Houben E. Laugesen K. Bothner U. Montonen J. Aguade J. Overbeek JA. Ehrenstein V. Asmar J. Wallace L. Gilsenan, AW. No Evidence of Off-label Use of Olodaterol and Indacaterol in Denmark, France, and the Netherlands: A Drug Utilization Study. Sci Rep 10, 586 (2020) doi:10.1038/s41598-019-57397-5https://www.nature.com/articles/s41598-019-57397-5
Fortuny J, Gilsenan A, Cainzos-Achirica M, Cantero OF, Flynn RWV, Garcia-Rodriguez L, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Plana E, Ruigomez A, Schink T, Ziemiecki R, Andrews EB. Study Design and Cohort Comparability in a Study of Major Cardiovascular Events in New Users of Prucalopride Versus Polyethylene Glycol 3350. Drug Saf 2019 Oct;42(10):1167-7740264_2019_Article_836.pdf
Margulis AV, Linder M, Arana A, Pottegard A, Anveden-Berglind I, Bui CB, Kristiansen NS, Bahmanyar S, McQuay LJ, Atsma WJ, Appenteng K, D´Silva M, Perez-Gutthann S, Hallas J. Patterns of Use of Antimuscarinic Drugs to Treat Overactive Bladder in Denmark, Sweden, and the United Kingdom. (epub). PLoS One 2018 Sep 27;13(9):e0204456 pone.0204456.pdf
Pladevall-Vila, M., Pottegård, A., Schink, T. et al. Risk of Acute Liver Injury in Agomelatine and Other Antidepressant Users in Four European Countries: A Cohort and Nested Case–Control Study Using Automated Health Data Sources. CNS Drugs (2019) 33: 383. 10.1007_s40263-019-00611-9.pdf
Castellsague J, Kuiper JG, Pottegård A, Anveden Berglind I, Dedman D, Gutierrez L, Calingaert B, van Herk-Sukel MP, Hallas J, Sundström A, Gallagher AM, Kaye JA, Pardo C, Rothman KJ, Perez-Gutthann S. A cohort study on the risk of lymphoma and skin cancer in users of topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal Lymphoma and Skin Cancer Evaluation – JOELLE study). Clinical Epidemiology 2018, 10:299-310https://www.dovepress.com/a-cohort-study-on-the-risk-of-lymphoma-and-skin-cancer-in-users-of-top-peer-reviewed-fulltext-article-CLEP
