British Society for Rheumatology Biologics Register
for Psoriatic Arthritis (BSRBR–PsA)
Tender Document
The British Society for Rheumatology (BSR) has a well-established track
record of successfully running the biologics registers for rheumatoid arthritis
based at the University of Manchester, and ankylosing spondylitis based at
the University of Aberdeen. BSR now wishes to establish a biologics register
for patients with psoriatic arthritis starting biologic and targeted small molecule
therapies (not exclusively anti-TNF therapy). We invite tenders to host,
develop and manage this register.
Various biologics registers across Europe collect data on psoriatic arthritis
(PsA), but the utility of this data can be adversely affected as existing registers
may:
a) fail to collect adequate data on PsA phenotype including: joint counts,
enthesitis presence and psoriasis severity
b) mainly recruit patients starting biologic therapy under dermatological care.
The primary purpose of the register will be to determine whether the rate of
serious adverse events e.g. myocardial infarction, cancer and infection is
higher in well-characterised PsA patients starting biological therapies/small
molecules, predominantly under rheumatological care, compared to PsA
patients not receiving biologic therapy.
A further important aspect of this register will be to determine clinical
outcomes for patients in the medium and long term, with a particular emphasis
on the impact of disease phenotype on outcome. This will help inform the
efficacy and appropriateness of current treatment guidelines and NICE
recommendations; provide data on optimal clinical effectiveness and costeffectiveness; and assess practical issues such as dose/interval changes,
duration of drug survival, drug switching and course of disease after drug
cessation.
The successful tender will need to be able to demonstrate the potential
benefits and opportunities that formal links to other registries may deliver.
Registries with possible benefits from linkage include: BSRBR-AS, BADBIR
and potentially a Europe-wide pharmaceutical register for a single biologic
agent.
Furthermore, the register will act as a resource for the wider academic
research community and for clinical rheumatology professionals. All data held
within the BSRBR-PsA is owned by BSR.
1
Electronic data capture is an essential requirement of the Register. It is
envisaged that data captured will have a degree of consistency with other
registries in rheumatology.
We welcome applications proposing collaboration between different
institutions providing different components. Applicants may also wish to
explore potential additional benefits from ‘bolt-on’ studies, such as genetic or
biomarker sample collection.
Applicants are requested to address the necessary steps to fulfil the purpose
of the register and specifically the following issues (please note: this is not an
exhaustive list):
1. Why your institution/department is particularly suited to host the
register
2. Ethical, governance and data protection issues
3. Compliance with MHRA pharmacovigilance regulations
4. Quality control
5. Online data capture methodology
6. Plans for the addition of new drugs to the BSRBR-PsA register
7. Training of data entering personnel at clinical centres
8. Oversight committee(s)
9. Appropriate reporting systems to the BSR and pharmaceutical
companies
10. Detailed financial breakdown.
11. Detailed statistical analysis of numbers of patients receiving biological
treatments and controls required
12. Clinical data to be collected at baselines and at subsequent time points
13. Employment/social/economic data to be collected
14. Plans for recruitment to achieve appropriate numbers within a realistic
time-frame
15. Plans to counter ‘data entry fatigue’
16. Plans to ensure good communication and close collaboration with
participating centres.
17. Open, fair and transparent process for access to data by researchers
from within and outside host institution
18. Plans for international co-operation and use of standardised clinical
outcomes
19. Linkage of patients and data with other registries
20. Dissemination plans with patients.
Please note, as a charity, BSR does not pay FEC
Please note: Although the pharmaceutical industry have indicated their
willingness to fund an PsA register in principle, the successful applicant will
not receive confirmation of funding from the BSR until definite costed
proposals have been agreed with industry following this tendering process.
2
Funding from one of the pharmaceutical companies involved may be
dependent upon a 2-way data sharing agreement between a pharmaceutical
company Europe-wide drug registry and BSRBR-PsA.
Applicants are encouraged to provide a range of costings to cover the
provision of a basic register through to a sophisticated service for an initial
5-year period.
Applications must be received by 5pm on 18th December 2014.
Applications will be peer reviewed and short-listed candidates will be
interviewed by a specially convened tender review committee. It is envisaged
that the successful candidate will discuss with the review committee any
required alterations (if any) to the application that arises from this process.
Only applications on the official BSR application form will be accepted.
3