The original REMOTE trial – the first ever to recruit and communicate with patients entirely via the internet – was shut down earlier this year after it did not attract enough US participants with overactive bladder (OAB).
However, according to the firm’s head of clinical innovation, Craig Lipset, the main reasons REMOTE did not work was overly stringent requirements for participation. He told us that with a few tweaks, Pfizer will try again soon – this time in the EU.
“The prevailing thought is that we were looking for cases of OAB of significant severity,” he said. “When people enrolled online reporting an over active bladder – which many did – they simply didn’t have the severity of disease that this particular protocol was looking for.”
In terms of the trial model, Lipset told us very few changes will be made apart from a few “internal alterations” and some changes to fit with the European regulators’ need.
“When you break the study down into core components we were able to recruit patients and manage them online to give them, and were able to safely monitor trial patients from a distance. We would consider it a success and we would use the data from it.”
When asked about the firm’s senior director of clinical sciences’ previous comments – in which he said aspects of the process were “quite complicated and tedious” – Lipset replied that the issue is not unique to virtual trials.
“The forms we are using certainly can be tedious,” he said, “But I think we will continue to find ways. When we look at the amount of data we collect, there are critical points where we could do much better.”
He went onto suggest that collecting more data virtually could be a way to resolve these issues, as patients could grant trial sites access to previous records at the click of a button.
“It would save collecting a huge amount of data we collect such as the patient’s past history. The information we need may have already been completed doing a routine exam.”
The future
Nevertheless, though Lipset was adamant virtual trials will shape the future of the industry – improving patient engagement, as well as engagement with healthcare professionals – he believes it will be a combination of models that will be the key to success.
He said future trials will work around patient convenience, and giving the option to participate in the most convenient way – whether that be online, using home visit nurses, on site or any new models which may emerge.
“We have different preferences as humans. The more we are able to offer patients that type of flexibility the better,” he said.
“Technology is a new way of putting all the information together. It will disrupt the entire model of getting clinical trials conducted around hospitals and trial sites.”
He added that industry must “align incentives” so that trial models such as home visits – which require a bigger outlay but often improves patient retention – can come to the forefront.
Lipset said: “We have seen cases where the patient will not be offered a home visit because the site will lose money. We can’t just tell the investigator site we will plan home care nurses. I think we need to properly align incentives so we can properly help the patient.”