We have developed and coordinated national prospective observational cohort studies in the UK for over 20 years.
Biologic Studies Group (BSG) is based at the Centre for Musculoskeletal Research at The University of Manchester. We primarily collect long-term post-marketing safety data for biologic, biosimilar and other targeted therapies in the treatment of musculoskeletal and dermatological conditions.
To do this, we draw on our state-of-the-art epidemiology and statistical methods expertise, plus strong international links and collaborations with similar studies. We are experts in the field of pharmacovigilance monitoring and comply with global regulatory requirements for drug safety monitoring.
Our studies
British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR)
Chief Investigator: Professor Chris Griffiths
Start date: 2007
Number of registrations: Over 19,500 registrations from 164 centres
BADBIR is a long-term prospective observational cohort study monitoring the safety and efficacy of biologic therapy in people with severe psoriasis.
British Isles Lupus Assessment Group Biologics Register (BILAG-BR)
Chief Investigator: Professor Ian Bruce
Start date: 2010
Number of registrations: Over 1,300 from 59 centres
BILAG-BR is a national study looking at the long-term safety and efficacy of biologic therapy in patients with lupus, compared with a group receiving standard immunosuppressive therapy.
British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA)
Chief Investigator: Professor Kimme Hyrich
Start date: 2001
Number of registrations: Over 30,000 from more than 160 hospitals
BSRBR-RA is our flagship study. It is the largest study of its kind in the world and has a high research output. It is a UK national study and is supported by a team of 17 staff.
Childhood Arthritis Prospective Study (CAPS)
Chief Investigator: Professor Wendy Thomson
Start date: 2001
Number of registrations: Over 1,700 from 7 centres
CAPS recruits children who are newly diagnosed with juvenile idiopathic arthritis. It aims to discover ways to predict how patients will manage over the long term.
Juvenile Idiopathic Arthritis (JIA) Studies
UK JIA Biologics Register
Chief Investigator: Professor Kimme Hyrich
Start date: BSPAR ETN – 2004, BCRD – 2010
Number of registrations: Over 3,400
BCRD and BSPAR ETN
Two studies called Biologics for Children with Rheumatic Diseases (BCRD) and BSPAR Etanercept Study (BSPAR ETN) are underway at hospitals throughout the UK to look at the safety and effectiveness of biologic, biosimilar and other new treatments for Juvenile Idiopathic Arthritis (JIA). As part of the studies, long term follow-up information regarding changes to the disease and any newer illnesses is collected to determine the safety and effectiveness of these types of treatments.
Adults with JIA
Planning for a future without fear: Studying the long-term health of people with JIA.
Dr Lianne Kearsley Fleet is a researcher at The University of Manchester. For the past 11 years, Lianne has been researching important questions for children and young people with juvenile idiopathic arthritis. She has recently been awarded a Versus Arthritis Career Development Fellowship to investigate what happens to children and young people with JIA as they transition to adulthood.
Visit the JIA Studies website: BCRD/BSPAR
Our funding
Our funding model helps maintain academic independence while we carry out the administration of our projects.
Most of our studies are funded through both contracts with charitable organisations and a separate contract for financial support with the pharmaceutical industry.
BCRD and CAPS are wholly charity-funded.
Our services
We are open to collaboration with the pharmaceutical industry and academic units. This is subject to relevant approvals from the study funders and scientific steering committees.
See below for more information on the data we collect from our studies and what we can provide. Please get in touch to discuss potential collaborations with us.
Reports for the pharmaceutical industry
Depending on the specific contract, participating pharmaceutical companies are provided with fully anonymised safety surveillance reports, including the following.
Standard ’24-hour’ serious adverse event reports
These report a serious adverse event (SAE) from the study to the appropriate company.
Monthly reconciliation lists
These ensure all SAE reports have been received by the company.
Annual datasets
These contain anonymised data and corresponding coding schedules.
Comprehensive six-monthly reports
These are sent to industry every six months using the Manchester Template agreed with the European Rheumatology Biologic Registers Group and industry representatives in 2002. It is reviewed regularly to ensure that rates can be compared effectively.
Each report is divided into three sections:
- demographics
- baseline characteristics
- crude non‐adjusted serious adverse events reported rates.
Access to comparison cohort data is also available.
To find out more about these services, please contact Dr Kath Watson (kath.watson@manchester.ac.uk).
Other available analyses
Ad hoc analyses as requested by regulators
We offer regulatory analyses on an ad hoc basis, via pharmaceutical companies who are obligated to respond to such queries from the European Medicines Agency, US Food and Drug Administration, and Medicines and Healthcare products Regulatory Agency, at a cost per analysis.
Academic analyses
Academic analysis of data collected by the studies within the BSG is ongoing. Publications from the flagship BSRBR-RA study are available to view and download on the BSRBR-RA website.
We can also provide access to a dataset for analysis purposes.
To find out more about these services, please contact Dr Kath Watson (kath.watson@manchester.ac.uk).
How we collect and process study data
We collect and process detailed safety data for all participants. A comprehensive pharmacovigilance standard operating procedure is in place to document this process, which is reviewed with industry on an annual basis.
We use patient questionnaires, clinical case notes and linkage with national databases such as NHS Digital to collect data. Detailed adverse event and serious adverse event (SAE) data is reviewed by the pharmacovigilance team, who code the events using the Medical Dictionary for Regulatory Activities (MedDRA) and look for any safety signals.
SAEs are reported to industry as required. Reports are sent to a Data Monitoring Committee. Analyses are undertaken to compare rates of SAEs, and findings are conveyed to the clinical community via published journal articles.
Contact us
If you wish to collaborate or apply for access to a dataset, please get in touch.
Dr Kath Watson
Programme Manager
Email: kath.watson@manchester.ac.uk
Contact Us
+44 (0) 161 306 6000
