Plataformes

Medical Statistics

Introduction

Medical Statistics is an IDIBAPS core facility that provides methodological and statistical support for IDIBAPS research projects and those of allied institutions. Depending on the project and the availability, the core facility may provide support to external public and private bodies.

The main objective is to promote clinical research excellence and facilitate resources to achieve this.

The Medical Statistics core facility was created in 2007 and currently collaborates in:

•             Projects and assessments: Involvement in 240 projects annually from 125 clients.

•             Spanish Clinical Research Network: Coordination of the Methodology, Biostatistics and Data Management Program of the Spanish Clinical Research Network (SCReN), which is financed by the ISCIII to promote independent clinical research.

•             Clinical Research Ethics Committee: executive meetings and evaluations of all clinical trials in our center.

•             Teaching: Degree courses in Medicine, Biomedicine, Statistics and Science and Food Technology, Autonomous University of Barcelona (UAB). Masters and specific courses on statistical methodology and data management, both for our institutions as well for external organisations.

•             European Clinical Research Network: Collaboration with and integration in the ECRIN European network. Spanish representative in the data management group. Participation in the Independent Certification Board (ICB). Permanent external reviewer of ECRIN standard operating procedures.

•             Scientific and statistical scientific and regulatory activities: Assessors of the Spanish Medicines Agency (AEMPS). Member of the Scientific Council of the Scientific Advice Working Party (SAWP) and the Biostatistics Working Party (BSWP) of the European Medicines Agency (EMA).

•             Scientific journals: Associate Editor of Trials. Statistical Advisory Board of PlosOne. Peer reviewers of various journals (Journal of Biopharmaceutical Statistics, Clinical Rheumatology, Trials, European Journal of Clinical Pharmacology, Medicina Clínica (Barcelona), Archivos de Bronconeumologia, etc.)

•             Publications: More than 220 publications in scientific journals with a cumulative impact factor of > 900. Participation in more than 20 publications per year in the last 5 years.

The core facility is self-financed with the income from work performed and institutional support received. Therefore, all services and tasks must be invoiced for according to the current rates published on the website (see link). We may, in exceptional cases, and always with prior authorization and IDIBAPS institutional validation, provide services that does not cover 100% of the costs in accordance with our rates and/or suggested budget (see detail in the appointment booking form).

NOTE: In all these cases, the costs that will be borne by IDIBAPS will be detailed for the user’s  information.

Services:

Assessments and consultancy Services

Short-term statistical and methodological assessments, including (a) statistical design of studies, (b) sample size calculation, (c) assessment of data collection for the analysis (d) methodological and statistical assessment of research projects.

Projects

Services for any project that requires more than short-term assessment will only be provided after a budget and time schedule are agreed.
Sample projects:
• Creation and maintenance of a clinical trials database: (a) creation of the eCRF (electronic cases report form), (b) creation of data management and validation plans and consensus with the research team, (c) traceable data exportation analysis systems.
• Statistical analysis of clinical trials or other projects: (a) creation of and consensus on the most appropriate statistical analysis plans according to the type of data and the study objective, (b) creation of the most suitable statistical program for the study objective, with emphasis on the traceability of results, (c) preparation of statistical reports, and collaboration in writing and supervising articles on monitoring studies.
See a longer list at the link

Appointments

Consulting services are provided on-site. An appointment is required and may be made by completing the following form

To facilitate assessments, prospective clients should provide documentation on the topic to be discussed, such as articles, similar works, protocols, and/or study outlines, etc.). This is particularly important for new study designs and predetermining sample sizes.


NOTE: Please book appointments well in advance as the service is subject to the availability of resources at any given moment.
 

Equipment:

  • Our team is fully equipped with the latest software for statistics and data management, including a) SAS, SPSS, R, JMP statistical programs b) nQuery for sample sizes, c) electronic Clinical Trials data collection: MACRO; and d) WinNonLin for PK/PD analysis.

Location

Location

Medical Statistics Core Facility
IDIBAPS - Hospital Clinic Barcelona
183, Mallorca Street, floor -1, Office #60. 08036 Barcelona

bioestadistica(ELIMINAR)@idibaps.org

Services request

Scientific Director:

Ferran Torres

Ferran Torres MD, PhD. (IDIBAPS)
Scientific Director
ferran.torres(ELIMINAR)@idibaps.org

Staff

Medical Statistics IDIBAPS