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BADBIR

<p>BADBIR</p>
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Who we are

The BAD Biologic and Immunomodulators Register (BADBIR) was set up in 2006 to follow all patients receiving biologic therapy for psoriasis in the UK and Eire. It is one of the largest psoriasis registers globally and is now in its 15th year of data collection.

Since being set up, BADBIR has collected a rich dataset of over 21,000 patients involving over 16 drugs. All drugs licenced for use in the UK have been recorded in BADBIR and we continue to follow up these patients.

BADBIR data is available to analyse and interrogate for the purposes of dermatology research.

BADBIR receives funding from pharmaceutical companies, but they are not directly involved in the study activities and not represented on the Steering Committee.

What we do

BADBIR aims to investigate the long-term safety for patients treated with biologic and new small-molecule treatments, compared with conventional systemic therapy. The Register collects a breadth of data, including basic laboratory values, systemic treatments, comorbidities, and psychosocial data. If you would like to see full details about the BADBIR Register the latest protocol can be accessed here.

As can be seen the BAD guidelines strongly recommend that all psoriasis patients on biologic therapies should be registered with BADBIR. The register also has support from NICE. There are currently 167 centres which have recruited to BADBIR across the UK and Ireland, see the map below:

BADBIR MAP

The activities of BADBIR are directed by two committees:

  • The Steering Committee provides strategic oversight of the study and ensures that the study meets its objectives
  • The Data Monitoring Committee provides independent oversight of the safety data collected for different drugs

Publications:

An important output of the Register are the studies published in journals that show treatment effectiveness and safety data for crucial drugs.

Some of the publication themes to date include Drug survival and effectiveness, Baseline demographics and Risk of cancer in patients on biologics. A full list of publications can be found here.

Invitation to use BADBIR data for your research:

The BADBIR Register has collected a wealth of important real-life data over a number of years and we welcome applications to use this data in analysis.

Developing your research question:

We encourage anyone who is interested in accessing the BADBIR dataset to review the following resources available to help develop your research question: the BADBIR active research questions (these are questions that the Committee has already approved and assigned to a group for analyses/publication), the Protocol, the Data dictionary, Frequently asked questions (FAQ), BADBIR publications policy, and list of BADBIR publications.

Applying to use the BADBIR dataset:

There is a two-stage process for applying to use the BADBIR data.

Stage one:

If you are interested in accessing the BADBIR dataset for research, please email a description of your data request to Joy Read (Research Coordinator) research@bad.org.uk . In your email, please provide the following information:

  • About you as the applicant (are you from clinical/academic)
  • A very brief outline of your research question
  • Whether you have funding/are applying for funding/have plans to apply for funding
  • Whether you plan to do the analysis yourself or would need analytical support from the BADBIR team

The BAD/BADBIR team will then discuss the next stages for your application with you.

Stage two:

The second stage involves submitting the data access application form for discussion at the next steering committee meeting. If the Committee approves your application, it will then be taken forward. The next steps will involve approval from the relevant pharma companies, signing of data sharing agreements and release of data.

An outline of the application process is shown in the flowchart below:

Research - Application and Review Process

Timelines

The BADBIR Steering Committee reviews all data access applications at their meetings. We request that you submit your data access application form at least 4 weeks ahead of these meetings which are usually held in February, June and October.

When planning the timelines for your analysis please be aware that it can take up to six months from the application until the data is released, depending on the complexity and scale of the request.

Costs to use the BADBIR data

There may be a case-by-case charge depending on the complexity of the request and this will be discussed with you.

Publishing your findings

When you publish your findings we encourage you to include the approved authorship guidance and acknowledgements which can be found here.

How to get involved

BADBIR is keen to receive expressions of interest from other dermatology departments who would like to join. We encourage all BAD members and their departments to become involved with BADBIR. To join as a participating site, contact the co-ordinating centre:

badbir@manchester.ac.uk

We encourage all pharmaceutical companies to join BADBIR. For more information, please contact shehnaz@bad.org.uk.

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