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Clinical Trials Innovation

‘Data integrity and patient safety underpins everything we do in managing clinical trials’, Dr Stephen Nabarro, CRUK

Dr Stephen Nabarro is Head of Clinical Operations and Data Management at the Cancer Research UK Centre for Drug Development. We spoke to him about how data is used in clinical trials today, as well as his work with the Experimental Cancer Medicine Centre Network.

Firstly, please could you explain a little about your role at the Cancer Research UK Centre for Drug Development?

SN: ‘I have worked at Cancer Research UK for fast approaching 10 years now and I am the Head of Clinical Operations and Data Management in our Centre for Drug Development (CDD). CDD plays a unique role in our industry as our remit is to do the highly complex, cutting edge early phase oncology trials that would not happen without our involvement. We sponsor numerous first in class trials, and it is incredibly exciting to see how patients tolerate being treated with a new class of drug and to see the emerging evidence of efficacy in expansion cohorts.’

In what ways does data quality and management impact clinical trials and drug development?

SN: ‘As we all know, data integrity along with patient safety underpins everything we do in managing clinical trials. Data quality for companies working on late phase trials will focus on getting marketing authorisation to licence their drug, but data quality has a different focus for those of us working on First in Human (FIH) trials. In my mind, on-site and in-house monitoring are vital to ensure the clinical trial data is provided as close to real time as possible and is of sufficient quality to enable the right decisions to be made at dose review meetings, as well as decision making to adapt the trial design based on emerging evidence. With the industry-wide trend for scientifically rich, biomarker driven early phase trials we are seeing more trials identifying Biologically Effective Dose (BED) rather than the traditional Maximum Tolerated Dose (MTD), which puts an even greater emphasis on the PK/PD data quality.’

In general, how well do you think data is managed in the clinical trials industry as whole? Where and in what ways can it be most improved?

SN: ‘The TransCelerate paper highlighting that less than 3% of changes to critical data arise from source data verification (SDV) has been a launch pad for sponsors to revisit how they monitor and clean clinical trial data. In my days as a Clinical Research Associate (CRA) I hated checking transcription of blood results, and it’s great that today’s monitors are freed up to focus on checking the critical data that matters and are becoming more site managers than transcription checkers. eSource has the potential to eliminate the manual process of transcription checking, but alas it will take a while before being suitable for early phase oncology trials.’

Are there other industries that clinical researchers could learn from in how to manage data?

SN: ‘Several friends have innocently asked me why it takes so long to go from a research idea through to patient impact with licencing a new drug and I find it really hard to justify the frighteningly long timelines. Having recently been on a Lean Six Sigma training course, it was fascinating to learn about the innovation by Henry Ford in 1913 with his car assembly line, and more recently the Japanese car industry’s ‘lean’ manufacturing. Let’s hope that adoption of new technology like eSource, embracing a risk adopted approach through the life of a project, and more innovative trial designs collectively mean we can accelerate progress in drug development and get drugs to market faster to maximise patient benefit.’

On your work with the Experimental Cancer Medicine Centre (ECMC) Network, what benefits do clinical site networks offer? What sort of metrics do you use to quantify the impact of the network?

SN: ‘The trend to form disease specific clinical trial networks of investigator sites is gathering pace across multiple therapeutic areas. The benefits we realise from working with the ECMC Network in the UK are numerous. For example, we have access to more than 350 Principal Investigators with such a diverse range of clinical expertise, and by working collaboratively with our PIs we can try very innovative protocols and trial designs.

It is far more than a network of clinical sites. Each Experimental Cancer Medicine Centre brings together a hospital and a university, so as a result we also have access to some amazing translational scientists to develop biomarkers for our trials.

We collect cross study metrics on all the ECMCs assessing study opening timelines, patient recruitment, EDC data flow, protocol compliance and much more. We have been working closely with the ECMC Network since they were formed 10 years ago and it continues to go from strength to strength.’

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