How CTAP supports clinical trial sponsors

CTAP has created the infrastructure, expertise and platform to support a wide range of CF clinical trials in the UK. We take a flexible approach when it comes to supporting sponsors, tailoring support to the requirements of the study design, phase and therapeutic area. This ensures CF studies opening in the UK have the best chance of success.

Benefits of working with CTAP:

• established clinical trials infrastructure 
• collaborative network of CF centres
• expertise in early phase and genetic therapy trials
• engaged community to support with PPIE
• data support from the UK CF Registry 
• promotion and engagement opportunities 

Since launching in 2017, CTAP has supported more than 70 studies, helped thousands of people take part in trials and significantly reduced the time it takes to get a trial set up.

Read our 2024 CTAP impact report

The UK has the second largest CF population in the world. There are more than 11,000 people living with CF in the UK and nearly 90% receive their care at a CTAP centre. There are established referral pathways in place from CF centres not part of CTAP, ensuring people with CF receiving their care at these centres still have opportunities to take part in trials. 

Since launching CTAP, we’ve transformed the CF clinical trials landscape in the UK by creating a collaborative network of paediatric and adult CF centres to support and deliver CF clinical trials. We provide the infrastructure to support sponsors with the planning and delivery of trials, and the platform for people with CF to access these trials. 

CTAP also plays a unique role in unifying the various support and services available to sponsors in the UK. We work closely with UK partner organisations such as the National Institute for Health and Care Research (NIHR) and the Health Research Authority (HRA). We also have links with international trial networks such as the European Cystic Fibrosis Society’s Clinical Trials Network (ECFS-CTN) and Cystic Fibrosis Foundation’s Therapeutic Development Network (CFF-TDN). Through these connections, we can streamline support for sponsors and help you navigate regulatory processes smoothly.

CTAP has created an established and collaborative network of CF centres across the UK. The majority of CF care centres in the UK are either an active member of CTAP or have pathways in place to refer patients to CTAP centres for study participation. 

Our network of 25 CTAP centres and 25 CTAP-funded CF trial coordinators have the expertise to set up and deliver all types and phases of CF trials, from early to late phase, from CFTR restoration to genetic therapies. 

CTAP centre expertise includes: 

• dedicated CF trial coordinators and experienced principal investigators
• navigational support with regulatory systems in England, Northern Ireland, Scotland and Wales
• clinical research facilities including lung clearance index (LCI), MRI and CT scans
• clinical trials pharmacy
• sweat testing equipment and expertise
• cardiopulmonary exercise testing
• sputum induction and bronchoscopy expertise
• digital technology and home monitoring capabilities.

The CTAP network includes several early phase centres with specific resources and capabilities to set up and run early phase trials, including genetic therapy trials (see below). 

Alongside our CTAP centres, we have several CTAP affiliate centres that work with CTAP to increase trial referral opportunities at their centres. 

See our list of CTAP centres

Our regional networks also support CF centres to refer patients for trial participation outside of their local CF centre. In addition to the established London regional CTAP network, we are setting up additional CTAP regional networks across Scotland and North of England, south-west England, and north-west England.

Several of our CTAP centres have the capabilities and resources to set up and run early phase trials. Our early phase centres provide the infrastructure, resourcing and expertise to deliver phase 1 and 2a trials, including genetic therapy trials. Capabilities include: 

• regional patient referral systems
• dedicated CF early phase trial coordinators and principal investigators
• experience of delivering early phase trials, including first-in-human
• experience of advanced therapy medicinal products (ATMPs), including genetic therapies
• capabilities to deliver inhaled genetic therapies
• access to on-site nebulisation chambers for study drug dosing
• facilities to support consecutive overnight stays with access to 24-hour nursing support.

CTAP also funds six dedicated early phase trial coordinators in CTAP centres across the UK: 

• Belfast Health and Social Care Trust (Northern Ireland) 
• Cardiff and Vale Health Board (Wales) 
• Manchester University NHS Foundation Trust (England) 
• NHS Lothian (Scotland) 
• Royal Brompton and Harefield NHS Trust (England) 
• University Hospital Southampton NHS Trust (England).

The Health Research Authority (HRA) strongly encourages all sponsors to engage with people with lived experience during trial design, known as patient and public involvement and engagement (PPIE). 

Our highly active Involvement Group is made up of more than 300 people affected by CF who are willing to share their knowledge and experiences with sponsors to support study design and delivery. 

We can coordinate PPIE to enhance and support all stages of trial planning, design and delivery. For example, we can facilitate focus groups and interviews to understand how to design trials in a way that is attractive and feasible for people with CF, or we can coordinate lay reviews of study documentation.   

Find out more about how we support with PPIE

CTAP also has the unique ability to provide data support from the UK CF Registry to help with different stages of trials planning and delivery. Approximately 99% of people with CF across the UK consent to sharing demographic, treatment, and health outcome data with the Registry. 

We can provide the data and expertise to support you with feasibility and site selection for all phases of clinical trials. We can also support with real-world evidence studies, pharmacovigilance and technology appraisal, to support your regulatory submissions. 

Watch our video on how our broader research support offer can support you. 

We can help with different aspects of trial recruitment and promotion through our active, collaborative network of CF centres and our Clinical Trials Hub communications. 

We can help with: 

• opportunities to engage with CF clinical teams at CTAP workshops and national CF clinical trial meetings
• recruitment referral pathways for your study, for example through our regional networks and CTAP championship scheme
• writing lay-friendly summaries of studies and results.
• promotion of studies and results via the Trials Tracker and CTAP communications.

We can support you wherever you are in your research process and provide tailored support to meet the needs of your study. Get in touch to find out more.

Get in touch with our Business Development Manager, Deborah Haworth

Watch our research support offer video

Read our brochure for sponsors