One of the major hurdles cited by Duffet in her work as a consultant for the Pennsylvania software firms is sponsors often create long highly detailed and repetitive questionnaires for trial subjects that would engender disengagement. Credit: shutterstock / fizkes
The burden of questionnaires and never-ending documentation may be holding back successful trials and driving patients away, a tech firm has warned.
This was the main message of a session at the 11th Annual Clinical Trials in Oncology conference in Munich that found that the average clinical study coordinator works an average of 17 studies seeing patients for only three hours each.
Taking to the stage, Daniella Duffet, senior solutions consultant for trial tech firm Suvoda, detailed how in her research approximately 58% of clinical trial sites are keen to implement systems such as e-consent to allow patients to agree to different aspects of a trial remotely. However, this progress was liable to be held up by tech-centric sponsors who may not understand the burden that taking so many data points directly from patients may entail.
One of the major hurdles cited by Duffet in her work as a consultant for the Pennsylvania software firms is sponsors often create long highly detailed and repetitive questionnaires for trial subjects that would engender disengagement by way of expecting a potentially unwell user to answer questions, some of which are likely to have been answered by previous questions.
Detailing her work with an anonymous sponsor who wanted to run a multi-national multi-site trial, Duffet elaborated that the firm saw success after they were convinced to cut down on the rate and size of their questionnaires, seeing 100% of the required results delivered in time and an above average rate of compliance.
Duffet said: “A company started with the data they wanted then listed off to us all the different questionnaires they needed and they ended up with a really long list. Their argument was that these questionnaires were needed to get the right data.
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“We took a look and told them they would have a few problems. These questionnaires were very repetitive and from a patient’s perspective they might not always enter the same data and then the sponsors would have conflicting information and that’s going to be a nightmare. It’s also going to reduce the amount of questions the patient actually answers. By reducing the number of questionnaires or simplifying them, or by allowing them to download an app, what this analysis saw was not only was it all delivered on time, sponsors would get all the information they needed.”
The talk also detailed how patients need to be made to feel as though they have a full understanding of the trial and what it is looking for, citing the experiences of Alica Staley who earlier in the conference detailed how she had turned down a clinical trial examining her cancer diagnosis purely due to receiving whole folders of unconcise information.
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