In February 2018, Combinations Alliance supported a two day meeting organised by AACR, FDA, and ASTRO to build on the work done by the joint working group in their landmark paper published in 2016 to boost the number of novel drugs being successfully registered in combination with radiotherapy. Since radiotherapy is one of the principal curative treatment options for patients with cancer, this is a very important initiative to improve treatment further.
Following the evaluation of the success of the Phase 1 of Radiation Assurance and a subsequent period of reviewer recruitment, the HRA have opened Phase 2 of Radiation Assurance and are now accepting all cardiology, neurology, oncology and rheumatology studies taking place in the NHS/HSC.
Information and guidance on Radiation Assurance can be found on their website.
Following a period of process development and successful reviewer recruitment, the HRA have opened Phase I of Pharmacy Assurance to all Phase I - II/III oncology studies taking place in the NHS.
Information and guidance on Pharmacy Assurance can be found on their website.
Following the success of Phase 1 of Radiation Assurance, the Health Research Authority (HRA) are inviting further Medical Physical Experts (MPEs) and Clinical Radiation Experts (CREs) to become registered reviewers in preperation for the launch of Phase 2 on Monday 12 November 2018.
During Phase 2, all studies involving cardiology, rheumatology and neurology, as well as oncology studies taking place in the NHS will accepted. Candidates should have experience of carrying out local IRMER compliance reviews, as well as lead MPE/CRE reviews.
In a first of its kind collaboration, research staff from two Welsh Hospitals came together in 2017 to plan the joint delivery of a complex clinical trial for cancer patients. Their efforts have paid off for Welsh patients, and have resulted in being shortlisted for a prestigious Nursing Times award.
Forty-seven delegates from across the research landscape (regulators, trials units, researchers, patients, trust R&D, funders and sponsors) came together on the 27 June 2018 to start work on producing a consensus paper about how we can streamline and promote innovative trials in the UK. The term innovative trials encompasses Platform, Umbrella, Basket, Complex , Adaptive and Modular trials.
You will have seen the output of the NHS England Consultation on commercial clinical trials.
NHS England with the NIHR are aiming to create a process that costs a multi-centre commercial project once only. The ambition being that this will speed up the set-up time and equalise out the variance in costs up and down the country, making the UK a more attractive place to bring research.
In June 2018, two currently open trials within the CRUK Combinations Alliance Portfolio have successfully defined their recommended phase 2 dose within the Dose Escalation Phase of the Trial, and have now opened their randomised expansion cohorts to patients in the target cancer type and setting via the ECMC network.