Collaboration
The LifeArc Centre for Acceleration of Rare Disease Trials (ARDT) includes a specialist trial management and statistics team dedicated to running trials in rare diseases. We welcome proposals for clinical trials to be supported by the ARDT team, and the affiliated Clinical Trials Units:
What we offer
Innovative and tailored trial design
- Specialists in leading trial methodologies including platform trials, compressed phase trials, Bayesian borrowing, and Synthetic Control methods
- Advanced statistical modelling and analysis and health economics expertise
- Customised protocols aligned with regulatory standards.
- Expertise in early-phase and late-phase trials.
- Expertise in the design and conduct of Studies Within a Trial (SWAT) to evaluate and improve the methods used in clinical trials
- Linkage and access to expert methodologists, including the Newcastle Biostatistics Group and NIHR-MRC Rare Disease Research UK Trial
Assistance with funding applications
- We can help identify the most appropriate funding scheme and calls for your trial based on research area, study design and timelines
- Guide you through the full funding application process; developing the submission and ensure that budgets are appropriately costed
- Collaborate with investigators and partners to produce competitive applications to meet the expectations of funders
Study set up and delivery, including UK and international sites
- Efficient participant recruitment through optimising screening processes and feasibility assessments
- High data integrity using bespoke databases created by dedicated programming teams or external databases by validated external data platforms
- Rigorous monitoring – dedicated monitoring team at Birmingham or use of Contract Research Organisation (CRO) for fit-for-filing trials
- Continuous quality assurance to ensure protocol compliance and patient safety throughout the trial
Inclusive patient-driven study design
- The ARDT includes a dedicated Lived Experience Advisory Panel (LEAP) made up of 14 diverse members from across England, Wales, Scotland, and Northern Ireland.
- The panel brings together people living with rare conditions, their parents or carers, as well as representatives from advocacy organisations.
Strategic industry collaborations
- Partnerships with leading pharmaceutical, biotech and mid-tech organisations
- Delivery of ‘fit for filing’ clinical trials delivered to a standard suitable for regulatory filing
- Compliance with MHRA, EMA and FDA standards
- Regulatory alignment from protocol design to database lock and submission readiness
- Focus on unmet clinical needs and delivering meaningful patient impact
End-to-end clinical trial support
- Partnerships with leading pharmaceutical, biotech and mid-tech organisations
- Delivery of ‘fit for filing’ clinical trials delivered to a standard suitable for regulatory filing
- Compliance with MHRA, EMA and FDA standards
- Regulatory alignment from protocol design to database lock and submission readiness
- Focus on unmet clinical needs and delivering meaningful patient impact
Adoption of full trial or assistance with specific aspects
- Our preference is to adopt the full trial, but we are happy to collaborate on specific aspects – e.g. assist with study design and statistical analysis etc.
How to apply
We welcome proposals for clinical trials that evaluate treatments for patients with rare diseases. We can work with investigators to develop trial designs, apply for funding, manage trials, and report and disseminate results.
We recommend you approach us as early as possible for collaboration with funding applications. This should be at least 12 weeks before the application deadline, if an appropriate funding scheme has been identified prior to proposal suggestion, but we are also able to help identify appropriate funding schemes. Proposals for collaboration are considered by the ARDT committee who meet on a regular basis.
Key criteria for considering collaboration:
- Evaluation of a treatment for rare disease
- Credible intervention with plausible potential
- Potential to change clinical practice
- Alignment with priorities of ARDT and LifeArc
If you would like to collaborate with ARDT on a clinical trial, please submit a proposal by completing the form (link below) and sending it to centreardt@contacts.bham.ac.uk along with any supporting documentation.
Frequently Asked Questions
Can the ARDT fund my clinical trial?
No. Unfortunately we cannot directly fund your trial, but we can help with the funding application, including identifying upcoming and open funding schemes and assist with developing your research ideas.
Does the ARDT offer any other expertise?
Yes. Along with specialist trial methodologists, management team and statisticians we can also offer input with health economics, development of Patient Reported Outcome Measures and design and conduct of Studies Within a Trial (SWAT).
Can I talk to a member of the ARDT team before submitting a collaboration request?
Yes, absolutely! Please email centreardt@contacts.bham.ac.uk and a member of the team will contact you.
What happens after I submit a collaboration request form?
Our leadership team will review your request and contact you within approximately two weeks to arrange an online meeting with you to discuss further.
Can my clinical trial be supported by the ARDT but run by a Clinical Trials Unit (CTU) that is not affiliated to the ARDT?
Yes. We are happy to collaborate with other CTUs.
If my trial will take place exclusively outside the UK, can the ARDT support me?
No. Although we are happy to support clinical trials with both UK and international sites, the trial must be based in the UK.
