Stephen Nabarro, PhD
Partnerships are vital to bringing novel, more effective medicines to patients affected by cancer.
A key challenge in forging new partnerships from a business perspective, is that both parties need to recognise what each is bringing to the table. I think partners that appreciate the added value that the other party brings to the table, are far more successful than those who are more restricted in their outlook.
A fundamental point that we try to bring out about CDD is the way that we work entirely through partnership and collaboration – partnerships with Industry and Academia, to source new drugs and science; the ECMC clinicians and research nurses for expertise and the operational staff at clinical trial sites for delivery; I should mention patients too – they are crucial! CDD spans the spectrum of drug development. We can deliver all the preclinical work, drive the program strategy and deliver science driven- Phase I clinical trials that will enable onward development, or will open up a new field of research etc.
Elaborating on the comment above, to deliver pioneering early phase oncology trials, we work closely with clinicians and scientists from the Experimental Cancer Medicine Centre (ECMC) network, which is an initiative jointly funded by CRUK and the health departments of England, Scotland, Wales and Northern Ireland.
One challenge for our industry is the reluctance of companies to partner with their competitors in order to test a novel – novel drug combination in clinical trials where there is a strong scientific rationale. A unique role of the ECMC Combinations Alliance (part of CDD) is that as a neutral party we can broker that relationship and can therefore drive forward new treatment option for patients.
Partnering for patient-centricity
Ultimately, of course, the key partner in all drug development collaborations is the patient, which is something CRUK keeps in mind when designing studies – all of which we aim to make as patient-centric as possible.
All CDD sponsored clinical trials are early phase often first in class or first in human trials and conducted for the benefit or future benefit of patients, we do not treat health volunteers due to the nature of our investigatory agents. This is also the case in Pharma at least in the oncology setting and the industry have to generate the data needed to support efforts to gain regulatory approval for new or better medicines.
But the difference with a truly patient–centric trial is that the protocol places a greater emphasis on the patients’ best interests, which is particularly important for early phase oncology trials were recruitment is a challenge.
As we all know, Phase I trials are used to determine the tolerability and effective dosage of a candidate drug as the basis for further examination in larger clinical studies conducted in subsequent years. This time needed to carry out late-phase research means very few of the cancer patients who take part in Phase I trials are likely to benefit from drugs developed as a result - many choose to participate for altruistic reasons.
This reliance on patients generously giving their time needs to be reflected in the protocols and to do this you have to really listen and act on patient advice. You have to find out what schedule might be tolerable for patients, or indeed, what might put them off participating. In the end, if you can make the trials more palatable and less onerous recruitment is faster and retention can be dramatically improved. This in turn leads to better data generation which will inform on future development.
Working with the regulatory authorities
CDD historically did 100% source document verification (SDV) like all other sponsors, but by adopting and really driving forward the use of risk-based monitoring, involving liaising with the MHRA for their feedback and input, we have shown that it is possible to conduct early phase oncology studies just as effectively and as safely but more efficiently. This increase in pace is enabling new treatments to be developed faster for patients.
The CRUK ECMC Secretariat have partnered with the HealthResearch Authority (HRA) to streamline and pilot several R&D processes across the ECMC network. The unique set up of the UK-wide ECMC network has the opportunity to undertake innovative ways of working that allows processes to be tested at a national scale and impact measured in a controlled manner. Working in partnership with the HRA, pharmacy and medical exposure reviews have been identified by the research community as being key bottlenecks during trial set up. These pilots have been a huge success in dramatically reducing the number of duplicate reviews, and as a result both of these R&D processes will form part of the technical assurance component of HRA Approval when it is rolled out across England in all Phases and all therapeutic areas at the start of 2016.
In summary, the hurdles and opportunities we have discussed emphasise the importance of bringing together all the key players at PCT-Europe to discuss key challenges and how to overcome them.