Participants

What is BADBIR?

BADBIR is an observational, prospective study open to patients undergoing treatment for psoriasis with either a biologic drug or standard anti-psoriatic therapy. If you'd like to get involved, please speak to your dermatologist as several eligibility criteria apply.

You may find the Patient Information Sheet useful if you would like to find out more about what participating in BADBIR involves. Additionally, the BADBIR study Transparency Notice is available to summarise use of data. The University of Manchester Privacy Notice for Research Participants is available here.

How is the study progressing?

There have already been some research publications from the BADBIR data - the latest papers are summarised in our latest patient newsletter.

Please follow us on Twitter for regular updates and information if you'd like to stay in touch.

FAQ

Here are some frequently asked questions about BADBIR. If you have any other questions, please feel free to send us an email at badbir@manchester.ac.uk

Q1: What is the BADBIR study hoping to find out?

BADBIR aims to assess the long-term safety of a group of psoriasis treatments referred to as biologics. Although these treatments are fully licensed and prescribed by the NHS, there is still a need to monitor their prospective impact as clinical trials are relatively short.

BADBIR will monitor one group of patients receiving biologics, and a second group who are receiving conventional systemic treatments for psoriasis. The rates of illness and adverse events in the two groups will be compared to see if there are any differences.

Q2: Why have I been asked to join BADBIR?

An invitation to join BADBIR means that you meet our inclusion criteria for one of the two patient groups that we recruit for, as mentioned above.

Q3: How will my participation help?

By participating, you will help us build up the amount of data we have for analysis. With more data, we will be able to reach better-informed conclusions on the long-term safety of biologic treatments. By consenting to participate in BADBIR, you are making a valuable contribution to this research, and are joining with over 14,000 other participants across the UK and Ireland.

Q4: How many participants are to be recruited?

BADBIR aims to recruit over 20,000 participants by the current study end date of 2028.

Q5: What information will you collect about me?

In summary, as you join the study we will collect some demographic information, a history of your overall health, psoriasis treatments you have had and details of the severity of your disease as you commence on treatment. Once you are part of the study, we collect an update on treatments you receive and, an assessment of your disease severity and details of any illnesses or adverse events suffered. For the first three years you are in the study we also request you complete a quality-of-life questionnaire. Full details of information collected are available via the questionnaires here:

Q6: Will my identifiable details be shared with anyone else?

Your identifiable information will strictly not be shared with anyone else, aside from the linkage services, including NHS Digital in England and Wales. This is the central source of health and social care information of the NHS. We share information with NHS Digital and other national providers of healthcare data as part of their routine flagging process.
The BADBIR Transparency Notice is available to summarise use of data. The University of Manchester Privacy Notice for Research Participants is available here.

Q7: Will my data be used in any other way?

A number of pharmaceutical companies who manufacture these biologic will have access to some study data. Your information will be de-identified i.e. it will not include your name, postcode, NHS/CHI number etc. This is so that they can update records with the international regulatory government agencies responsible for drug safety.

Your hospital medical records will state that you are in this Register. By signing the consent form, you are allowing the dermatology team to permit these records to be viewed by the BADBIR team at the University of Manchester or possibly agencies such as the MHRA or authorised members of the Ethics Committee or Hospital. This is for the purpose of checking that the data is correct or checking that the study is being carried out properly.

Q8: How long will I need to participate for?

Each participant will be followed by their dermatologist until the current study end date of 2028.

Q9: What happens if I no longer want to take part and don't want my details being stored?

If you wish to withdraw your consent, you can contact the BADBIR team directly on 0161 306 1896, or via email at badbir@manchester.ac.uk. Alternatively, you can speak to your dermatology practitioner who will inform us of your withdrawal.

Q10: I have an issue with the BADBIR Study. Who should I contact?

If you have a concern about any aspect of this study, you should ask to speak to your dermatology research team who will do their best to answer your questions. If they are unable to resolve your concern or you wish to make a complaint regarding the study, please contact a University Research Practice and Governance Co-ordinator on 0161 2757583 or 0161 2758093 or by email to research-governance@manchester.ac.uk. With regards to upholding your subject rights such as subject access requests within the BADBIR study or with regards to how the University processes your information please contact information.governance@manchester.ac.uk.

Q11: Which hospitals are participating in the BADBIR study?

To date, 157 centres from across the UK and Ireland have recruited to BADBIR:.