Published: 08 January 2020
New recommendations for cancer trials, made by the NIHR-funded* Experimental Cancer Medicine Centre (ECMC) network, could reduce the time it takes to get innovative treatments to patients with cancer.
The 10 recommendations are published in the British Journal of Cancer and should allow for more trials to be carried out that address multiple clinical questions at once - for example evaluating different treatments at the same time. The authors are now calling on clinicians, funders, regulators and the pharmaceutical industry to get behind the recommendations and work together to rapidly implement them.
Complex Innovative Design (CID) trials are increasingly used 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, CID trials can be challenging to conduct and there are currently no practical guidelines for teams that fund, design and conduct these trials in Europe.
The ECMC network, funded jointly by the NIHR, Cancer Research UK, 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. They developed ten key recommendations to help researchers conduct high-quality CID trials.
Each recommendation covers a specific 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.
Taken together, these recommendations could improve the conduct, quality and acceptability of oncology CID trials in clinical research. Furthermore, improving how different stakeholders interact, promote and share their learnings from CID studies, say the authors, will foster a research environment that could enable CID trials to be carried out in a range of new clinical areas.
Nick Lemoine, Medical Director at the NIHR, said: “Getting promising new cancer treatments to patients who need them the most can take some time, so speeding up this process through Complex Innovative Design trials is a priority. With the expertise within the ECMC network and the new guidelines in place, the UK is now one of the best equipped countries to deliver these trials, which represent the future for evaluating new cancer drugs.”
Professor Pam Kearns, director of the Cancer Research UK clinical trials unit at the University of Birmingham and co-author of the paper, said: “We owe it to our patients to bring potentially more effective novel treatments into the clinic as quickly as possible, and these recommendations will ensure we have good quality CID trials in place to deliver this promise.”
*The ECMC is joint funded by the NIHR, Cancer Research UK, and the health departments in Northern Ireland, Scotland and Wales. Find out more about the ECMC: