Biologic Studies Group

Studying the safety and efficacy of biologic, biosimilar and other targeted therapies in musculoskeletal and dermatological conditions.



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

Biologics for Children with Rheumatic Diseases (BCRD)

Chief Investigator: Professor Kimme Hyrich

Start date: 2010

Number of registrations: Over 1,400 from 38 centres

A sister study to the BSPAR-ETN, BCRD recruits children with JIA starting treatment with biologic therapy other than etanercept, alongside a comparison group of children starting methotrexate.

Visit the BCRD website

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.

Visit the BADBIR website


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.

Visit the BILAG-BR website


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.

Visit the BSRBR-RA website


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.

Visit the CAPS website


British Society for Paediatric and Adolescent Rheumatology Etanercept Study (BSPAR ETN)

Chief Investigator: Professor Kimme Hyrich

Start date: 2004

Number of registrations: Over 2,000 from 51 centres

This national UK study recruits a cohort of children with Juvenile Idiopathic Arthritis (JIA) who are starting etanercept, alongside a comparison group starting methotrexate. Originally established at the University of Birmingham, the BSPAR ETN study moved to the BSG in 2010.

Visit the BSPAR ETN website




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 (

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 (

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