Data management
but their tumour hadn’t grown enough for them to be classed as such, a clinician could still decide that their disease had progressed, even though, according to the trial markers, it hasn’t, explains Stuart. So, which measure should be used? For cases like these, Stuart says they have built an option into their database for “clinician- confirmed progression”, which can override scan results. “Because at the end of the day, the clinician does probably know best,” she says. “It seems a bit harsh to say, ‘Oh, the computer says that person is not sick enough,’ when they are.”
Tumour size does not always align with how sick a patient becomes, so there’s another data point in trials where a patient’s doctor feels there has been a progression without tumour growth.
with to send a sample report, so you can plan how you’ll integrate all the results into one. Sometimes, results need to be queried and followed up. In clinical trials, tumour scans must be reported on in a specific way, following a set of criteria called RECIST – which is not typically used in routine care. If you need to use an NHS radiologist who doesn’t work with RECIST – which stands for Response Evaluation Criteria in Solid Tumours – they might report in a different way, says Stuart. When those scan results are the most important measurements to be collected in the trial (the primary outcome), teams need to go back to that radiologist and try to get them to conform to the required way of reporting. “If they don’t, then you literally just can’t use that site,” she says. And if there’s real-world patient data in the mix, standardisation can be especially tricky, because the quality of that information can vary. To make matters worse, there isn’t currently any guidance on the best way to go about it, says Hall. “There needs to be a consensus on how to derive standardised outcomes and definitions from routine data… Routine data is inherently messy, so it would need manipulation.”
Measuring results 5% 16
The percentage of all trials in Britain that used data from routine care systems between 2013- 2018.
Health Data Research UK
One of the main outcomes that oncology trials measure is the time to event – with the event usually being a progression in tumour growth or death. While measuring the latter is straightforward, there can be ambiguity when determining whether a patient is improving or becoming more unwell. Per RECIST, a therapy is considered beneficial when a tumour shrinks by 30% or more compared to its size before treatment started, while disease is said to be progressing if it grows by at least 20%. Yet, a clinician’s assessment of a patient might not fall so neatly into those categories. If, for example, someone appeared to be getting sicker
It can also be unclear exactly when a tumour has progressed if patient scans are many months apart. “They could have progressed at four months, but you didn’t know until the six month point,” says Stuart. “When you’re trying to decide whether people in the control arm versus people on the treatment arm progressed quicker, you’ve got to have a bit of leniency in how you’re thinking about it.” If everyone came in for their routine scans, this would all come out in the wash – but often, people miss them as they’re too ill, she adds. Here, teams might turn to real-world data to fill in the blanks. However, routine health data regarding tumour growth probably won’t have been reported using RECIST – and at present, there’s no alternative agreed-upon measure for use in trials. “You either need to extract all the scans and get a research team to measure everything retrospectively, or you need to develop some new definition of what real world response should be,” says Hall.
More trials, more data
From 2000-2020, the number of oncology drugs in development grew by 6.5% per year – and the CSDD predicts that in the coming years, cancer trials will become even more complex and generate even greater volumes of data.
Hall hopes to see trials collect data that informs a wider variety of decision makers beyond just regulators, with the aim of more thoroughly evaluating the value of a therapy. “There’s a whole load of data missing from clinical trials…like the characteristics of the true population rather than the selected population in the trial,” he says. “And all of the health system information that’s necessary to fully assess the impact of a treatment.” But in the meantime, we’re in good hands. For all the difficulties that come with oncology trials, Stuart notes that in her experience, they’re managed fairly well. “I think because we’ve been doing cancer trials for so long now…they’re actually run smoothly for the most part. Any issue that comes up has come up at some point before and we know how to deal with it.” ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Ground Picture/
Shutterstock.com
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