On-site clinical trials are widely considered to be the norm, but they’re far from perfect. In fact, there are a number of common challenges that are experienced by on-site clinical teams which can increase the risk of failure. Here are 4 of the biggest concerns:
- Site Selection
When conducting an on-site clinical trial, one of the initial considerations must always be the selection of a suitable site. However, this presents an immediate challenge for clinical researchers, with sources claiming that administrative tasks such as contract reviews and Institutional Review Boards (IRB)/Ethics Committee (EC) approvals mean that site activation can take as long as 3-6 months +, creating a clinical delay even before the project starts.
We must also consider the possibility of site bias. A report by online life sciences community Xtalks suggests that only 30% of sites are new to a clinical manager, which means that 70% have been used by the practitioner previously. The question then arises of whether sites are being selected for their relevance to the trial, or for their familiarity.
- Measurement Bias
And site bias isn’t the only concern. There’s also measurement bias to take into account, too. On-site clinical trials rely heavily — almost too heavily — on the presentation of symptoms and side effects at convenient times. High fevers as a result of trialled drugs, for example, can only be measured if they appear during on-site visits or hospital appointments. And as we all know, symptoms don’t always like the play by the rules. There is a very clear need for an alternative form of monitoring for accuracy.
Perhaps one of the biggest differences between on-site and off-site clinical trials is the methods that are used to collect data. With on-site trials, data is typically collected retrospectively during patient visits, and this is a factor that could be facilitating the growing trend for elongated projects. An Oracle Health Sciences-sponsored report suggests that clinical teams are spending more time cleaning data than analysing it; the result of a failure to access real time data, leaving problems going undetected and creating the need for lengthy data cleansing. To improve trial speed and minimise the need for timely correction tasks, creating access to real time data should be a priority.
- Dropout Rates
But perhaps the most prominent on-site challenge facing clinical researchers today is the high dropout rates that are being observed in trials of this nature. Dropout rates can be more than 30%, so it’s no wonder that patient retention is one of the biggest pressure points for clinical teams. And with the average patient cost per trial standing at between $35,000 and $40,000, dropouts can really add to the financial pressure, too. But the question we need to ask is why do so many patients drop out of on-site studies?
The answer is simple: patient burden. Patient burden is so real that technology company Medidata actually generated a Patient Burden Index. Quite simply, on-site trials are effortful for patients who may need to take time off work for monitoring or hospital appointments, or even travel long distances to reach the clinical trial site.
What’s the Solution?
It seems clear that if on-site clinical trials are generating challenges that are directly affecting the success rates of projects, then off-site alternatives could be considered as a solution. Looking at the most recent challenge we discussed (dropout rates), virtual clinical trials can significantly ease the burden for patients through digital reporting and monitoring, perhaps making it easier and more enjoyable for patients to keep participating. What’s more, the benefits of virtual, off-site trials extend to the three other concerns too.
The issue of time, for example, can be overcome through effective delegation of tasks to skilled clinical associates provided through CROs, including project, clinic, and data managers, medical monitors, mobile research nurses, site coordinators, administrators, directors, and pharma legal specialists. The challenge of site selection is negated, and measurement bias can be overcome through ‘always on’, constant remote monitoring.
While decentralised/off-site trials are still very much an emerging area, virtual CROs like Virtual Clinical are already providing the necessary services that pharma companies need to expand into this area, digitise their processes, and create a more efficient way of working. Get in touch with us to find out more about our specialist solutions