Monday, November 28, 2016

The importance of networks in clinical trials

Interview with Aoife Regan, Head of Experimental Cancer Medicine team at Cancer Research UK

Networks are gaining increasing importance across various different aspects of clinical trials. The Experimental Cancer Medicine Centres Network is one such project made up of 21 locations across the UK, each a partnership of at least one NHS Trust and one university.

Aoife Regan heads up the team that supports the ECMC Network through training, sharing best practices, helping industry in accessing the network and providing opportunities for professional groups to network.

Following her presentation at Partnerships in Clinical Trials Europe, we spoke to Regan about the network, as well as the importance and challenges of such partnerships within clinical trials.

What exactly is the ECMC Network?

‘The ECMC Network is 21 locations in the UK that through a process of peer review have been selected as the best places to conduct experimental cancer medicine, including early phase trials, and associated translational research, in both the adult and paediatric setting. Each location is a partnership of at least one NHS Trust and one university. These locations receive a flexible funding award that they can use to employ staff either in the University or at the hospital to help deliver studies. 

The network is funded in partnership by Cancer Research UK and the health departments of the devolved nations of the UK with a combined investment of £35m over the last five years.’

What benefits do clinical site networks offer?

‘It is important to note that the ECMC network is not just a clinical site network, it includes the local university which can offer expertise in biomarker development and other translational research that you may not find in the clinic. The benefits of working as a network are manifold, and too many to cover here, but as a starter for ten: 
  • - No single site, regardless of size or reputation, can offer the full range of expertise, facilities and capacity required to deliver a broad spectrum portfolio of studies for all cancer types in all treatment modalities. By working as a network we can deliver more studies in more therapeutic areas increasing the potential to deliver benefit to patients. 
  • - As trials become increasingly stratified, getting access to patients can be a rate limiting step in the delivery of studies. Even the larger centres can struggle to recruit the requisite numbers of patients in the required time. By being able to tap into a network of centres, we can rapidly increase the recruiting potential for studies.
  • - Our network is supported by the ECMC Programme Office. The PO works to streamline and harmonise processes across the network, for example by creating legal agreements that can assist industry in accessing the entire network rapidly. 
  • - By creating a network we have set the expectation that best practice should spread across the network, and indeed the Programme Office actively facilitates this.’

What metrics do you use to quantify the impact of the network?

‘For a complex network, it’s not possible to tell the full story of impact through metrics, and in fact it is dangerous to do so. We collect the usual trial metrics; number and type of studies, trial set up and delivery etc. We also keep a keen eye on how ECMC funding is used to leverage funding from other sources, commercial and not for profit. 

Defining impact is a lot harder. It can be thought of in terms of patient impact – but as we are an early phase network we don’t conduct registration studies and there is a long time lag between a study coming through the network and it making any difference to patients (although as we are ten years old, we do have some examples of ECMC supported studies contributing to the development of drugs now on the market, eg abiraterone). 

As patient impact is a distant measure we do look for proxies, and monitor which ECMC supported studies lead to later phase studies. As well as the metrics, we ask our sites to provide case studies on a regular basis so we can capture the complexities that metrics don’t portray.  We will be releasing an impact report in 2017.’

What are the biggest challenges faced in running such a network?

‘I should point out, the Programme Office does not ‘run’ the network, rather we support investigators and other professionals in the network to achieve their aims, which are aligned to the aims of the funders. The investigators in the network have total control over what studies they choose to undertake. 

One potential strain in the network is that investigators are expected to compete for funding every five years, but are then expected to work collaboratively for the benefit of the network. One way we have worked to try and lessen the impact of this is to include an evaluation of contribution to the network when making funding decisions. We only fund the best researchers, but we expect them to participate in the network, for example by recruiting to studies from other locations, or by helping to train the next generation of researchers.’  

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