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Data management


Oncology’s data puzzle


Oncology trials generate huge volumes of data from many different sources, and they do so over long periods of time. The payoff of demonstrating an effective therapy for cancer can be huge for patients and pharmaceutical companies, but collecting, cleaning, analysing and interpreting data from studies can be a challenge. Monica Karpinski speaks to Peter Hall, senior clinical lecturer in cancer


informatics at the University of Edinburgh, and Charlotte Stuart, head of data management and information systems at the University of Southampton’s Clinical Trials Unit, to find out why certain data management challenges are unique to oncology trials, and how organisers and statisticians work to overcome them.


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n average, it takes 14-18 months longer to run each phase of a cancer clinical trial than those in other fields. Oncology trials also tend to involve more sites, patient visits, and protocol deviations – and a lot more data collection. For instance, phase II cancer trials generate 3.1 million data points per protocol, compared to 1.9 in non-


oncology trials. At least, that’s what Tufts University’s Centre for the Study of Drug Development (CSDD) estimated in a 2021 report. But for those on the ground in oncology drug development, the above figures perhaps won’t come as a surprise. Over the past decade, cancer trials have shifted in focus from traditional chemotherapy to more


Clinical Trials Insight / www.worldpharmaceuticals.net


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