Despite increasing numbers of radiotherapy trials and rising recruitment, a continuing challenge has been increasing the number of trials evaluating radiotherapy and novel agent combinations. Little progress has been made in combining drugs and radiotherapy in recent decades, despite new drugs that could be effective.

Radiotherapy-drug trials is an area of research that is complex in its design, set-up and regulation, which may contribute to the lack of trials in this area despite the potential to help patients.

To address this need, NCRI’s radiotherapy research working group, CTRad, and one of its partnership consortia RaDCom (Radiotherapy-Drug Combinations Consortium, supported by CTRad and CRUK’s Experimental Cancer Medicines Centre, is a collaborative network of UK-based laboratories working in partnership with industry, CRUK and other funding bodies) brought people together in some workshops to discuss blocks to trials and explore what the UK research community can do to improve the overall situation.

To successfully set up these trials will require industry support. Industry partners told CTRad that the steps and regulations are unclear and the trials are often perceived as hard to do, hence there’s little willingness to invest. Researchers and clinicians have many insights into how to develop these types of trials, and bringing them together with industry to support them in the development could be the catalyst that results in real progress being made.

CTRad, with its working relationships with relevant stakeholders, is uniquely placed to foster collaboration between these various groups to overcome the barriers that are preventing progress.

Delegates from the workshops developed eight separate consensus recommendations where they thought that they could increase the number of novel drugs being successfully used in combination with radiotherapy to improve clinical outcomes for patients with cancer.

These consensus recommendations were published in a position paper in Nature Reviews Clinical Oncology.

The paper has encouraged academic investigators to plan new radiotherapy-drug combination studies and to interact more proactively with industry from the start.

Professor Sharma, lead of the Academia-Pharma Joint Working Group

The impact of the paper has spread beyond its initial target of the UK research environment. The paper has opened up discussions for NCRI’s CTRad with European research organisations, and worldwide regulatory agencies seeking to improve their guidelines in the area of radiotherapy-drug trials. This includes a US-based meeting in early 2018 that included the US drugs regulator, the FDA. A paper summarising the discussions of this meeting has since been published in Clinical Cancer Research authored by a senior clinical oncology trainee, Professor Sharma, various CTRad members and others. It explores the barriers and challenges to drug-radiotherapy combinations entering the clinic, and sets out recommendations to increase the success of novel drug-radiotherapy combinations.

We brought together a few key stakeholders that had not previously been brought together before: academia, pharma, the regulators, and consumer groups. As a result of that unison between those stakeholders, we produced an important paper that led to the need for a much bigger workshop, the FDA-AACR-ASTRO Clinical Development of Drug-radiotherapy Combinations workshop in Bethesda, USA, to really broaden this to an international perspective. The CTRad consensus paper has really helped to catalyse important discussions and get this topic in the international spotlight. The meeting organised by the FDA, AACR and ASTRO was an important step in bringing all interested parties together to develop appropriate regulatory guidelines for drug-radiotherapy combination studies. Thanks to NCRI’s CTRad, the UK is leading much of this work internationally and we are able to share insights, expertise and learnings to further our work with European and US colleagues.

Professor Sharma, lead of the Academia-Pharma Joint Working Group