Trial sites and sponsors have been urged to consider the burden of arbitrary data collection on patients participating in trials during a panel discussion about integrating imaging technology into oncology trials.
The panel at the 11th Annual Clinical Trials in Oncology conference in Munich dove into topics across the subject of medical imaging, with a special focus on how sponsors and contract research organisations (CROs) need to understand that expecting patients to commute multiple hours to imaging sites and trial centres to hand over data with an unclear purpose, may not contribute to the kind of outcomes they are hoping for.
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Taking to the stage at the Munich Sofitel Bayerpost hotel on 3 December, the panel engaged the vice president for patient engagement at Medidata Dassault Systemes, Sarah Westall, alongside colleague and patient engagement specialist Alicia Staley. Also joining the panel were patient advocate Justus Harris and COO for Node Pharma, Helen Johansen Blanco.
When asked how the burden of commuting to a site may impact a patient’s ability to take part in an oncology trial that requires some form of imaging, Sarah Westall pointed out that the industry is getting ahead of itself in implementing new technology into trials without real consideration as to how it will work for the patient.
Westall said: “It feels like we are jumping from imaging feeling like this new thing we have to figure out how to manage as data managers, to how do we decentralise this? Unlike some things you can decentralise, with imaging you can’t just go putting an MRI scanner into someone’s front room. Usually, we have unwell patients travelling long distances to get to trial sites and it’s a lot to ask. It is a balancing act.”
Responding to Westall, Helen Blanco iterated that Node Pharma trialed the use of satellite trial sites throughout the Covid-19 pandemic but found that the regulatory burden in sharing data gathered in those satellite sites presented a significant challenges that made the system difficult to work with.
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By GlobalDataShe went on to add that the group had seen some success retaining patients when they cut the rate at which patient surveys were carried out from once per six weeks, to once per nine weeks, lessening the paperwork demands on patients.
When asked to address some of the hurdles felt by moving certain forms of imaging away from trial sites and into the hands of patients, the panel were adamant that one of the primary motivators to keep patients in trials was ensuring that they had a full understanding as to what the data will be used for and what will be gained by collecting it.
Justus Harris argued that from his experience in several at-home clinical trials including diabetes trials, one difficulty was getting a clear understanding as to what researchers are trying to achieve with patient data, something that at the same time could result in potentially unreasonable patient expectations.
