Competence Centre for Clinical Research

Competence Centre for Clinical Research

Scania Region, Sweden Peter Höglund

E-mail: Peter.Hoglund@skane.se

Competence Centre for Clinical Research

• New department for methodological support in co-operation between the Scania Region and the Faculty of Medicine, Lund University

• Main target group: Investigator-initiated clinical trials or epidemiological studies in our Region

Spheres of Activities

• Clinical Trials

• Epidemiology

• Biostatistics

• Data Management

Types of Activities

• Active partner in all phases of a research project

• Support activities

• Consultations (by e-mail or by phone)

• Education

-Scheduled courses -Tailor-made courses

Current Personnel

• Head of operations (Clinical pharmacologist)

• Biostatistician/Epidemiologist

• Biostatistician/Data manager

• Research nurse/CRA

• Administrative secretary

Clinical Trials

• Protocol design

• Applications for IEC and MPA

• Informed consent

• Case Report Form, database

• Study team organisation, logistics, and performance

• Monitoring

• Education in GCP - Good Clinical Practice

Clinical Trials

• Standard Operating Procedures – SOPs

• Quality Assurance/Quality Control

• Research nurses/CRAs educated for QA of investigator-initiated studies in the Region

• Network for research nurses/CRAs

Biostatistics

• Study design

• Power calculations, sampling

• Statistical analyses

-Multivariate modelling

• Review of manuscripts

• Education

Epidemiology

• Study design

• Power calculations, sampling, control selection

• Epidemiological analyses

-Measures of risk

-Multivariate modelling

• Meta-analyses

• Review of manuscripts

• Education

Data Management

• Guidance regarding data sources, data collection methods, data security

• Contacts with data source providers

• Database administration

• Statistical programming

• Data quality ascertainment

Examples of Tasks

• Study design for clinical trials

• Quality assurance/Quality control

• Pharmacokinetic modelling

• Multivariate analyses of contact allergy data

• Education (scheduled as well as tailor-made courses)

• Many shorter consultations