The new funding, which follows the CFF’s initial investment in 2016, will extend current Trial Coordinator posts for a further three years and introduce early phase trial coordinators to provide specialist support to phase 1 trials.
With more advances in CF care and a host of new medicines in the pipeline, this is an exciting time for the CF community. The funding from the CFF will help to ensure people with CF have the opportunity to benefit from new treatments as quickly as possible by supporting rapid recruitment to and completion of clinical trials.
Clinical trials are an essential part of ensuring ground-breaking medicines become available to the people who really need them whilst still ensuring they are safe and effective. Since its launch in 2017, the Trials Accelerator has become embedded in the CF trials landscape. The programme has helped to raise awareness and recruit more people with CF to trials by bringing together CF centres across the UK and provide them with a dedicated CF trial coordinator, as well as developing the Trials Tracker, a leading resource for people with CF to track clinical trials they can take part in.
Trusty Trial Coordinators
Cystic fibrosis Trials Coordinators are one of the critical success factors to the Trials Accelerator, providing each centre with a dedicated resource to support set-up and delivery of high priority CF clinical trials. When the programme was first launched, each of the participating centres were awarded three years of funding to employ a Trial Coordinator. Thanks to the CFF’s investment, we will be able to fund their role for an extra three years.
A helping hand – early phase coordinators
Early phase trials, often referred to as 'Phase 1', are usually small trials, recruiting a small number of people, with or without cystic fibrosis.
The principle objectives in Phase I are to:
- make sure that the new medicine presents no major safety issues;
- clarify that it can reach the targeted body area, and remain there long enough to deliver its benefits;
- establish minimal or most effective doses; and
- gain preliminary evidence that it could offer therapeutic value.
We predict there will be an increase in early phase CF trials in the foreseeable future, and it is vital the Trials Accelerator helps create the infrastructure within the UK to support successful phase 1 delivery. As part of the investment from the CFF, we will fund a small and specialist team of early phase trial coordinators to specifically focus on this area, aiming to speed up delivery and recruitment. These coordinators will be embedded within the wider CF team and will also help to provide access for the people with CF who would be prepared to participate in these trials.
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