Researchers call for adoption of new guidelines to get medicines to cancer patients quicker
10/01/2020
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A group of researchers have developed a set of ten recommendations to improve Complex Innovative Design (CID) trials, which could ultimately reduce the time it takes to get innovative treatments to cancer patients.
The recommendations were published on Monday 6 January 2020 in the British Journal of Cancer.
The corresponding author for the study was Prof Sarah Blagden of the University of Oxford's Department of Oncology, who is an Honorary Consultant at Oxford University Hospitals NHS Foundation Trust.
The research group, which also included Sarah Pearson of the University's Oncology Clinical Trials Office, is now calling on clinicians, funders, regulators and the pharmaceutical industry to get behind the recommendations and work together to rapidly implement them.
CID trials are increasingly being used as an evaluation method by researchers, instead of traditional drug development pathways involving clinical trials from phases 1 to 4.
The CID approach enables researchers to carry out more complex trials that address multiple clinical questions at once. For example, a drug can be simultaneously evaluated for safety and efficacy with different cancer types, which can change as the trial progresses, accelerating the traditional route to drug licencing.
However, they can be challenging to conduct and there are currently no practical guidelines for teams that fund, design and conduct these trials in Europe.
The Experimental Cancer Medicine Centre (ECMC) network, funded by Cancer Research UK, the National Institute for Health Research (NIHR) and the health departments in Northern Ireland, Scotland and Wales, convened a working group of academics, funders, regulators, pharmaceutical industry representatives and patients to address this challenge.
Each of the ten key recommendations they have developed cover each stage of the clinical trial pathway, including: trial planning and design, protocol development, patients and public involvement, patient-facing documentation, statistical analysis, defining leadership and oversight, dissemination of results, staff training, the approval process, funding, and evaluating the impact on public health.
Prof Blagden said: "These recommendations have the potential to improve the conduct, quality and acceptability of oncology CID trials in clinical research. Furthermore, if the various stakeholders work together to share their learnings from CID studies, it will foster a clinical research environment that could enable CID trials to be carried out in a range of new clinical areas."
"This should result in more effective novel treatments for cancer being brought into the clinic more quickly, which ultimately will be good news for patients."
Dr Aoife Regan, head of the ECMC programme office, said: "These recommendations show the power of the ECMC network as a convening force to help strengthen the position of the UK as a world leader in experimental cancer medicine. We hope these recommendations will have an impact not just for cancer research but for all complex trials across all disease types."