How viable are virtual clinical trials as a model for conducting clinical research?
With our deepening understanding of disease and ever more targeted therapies, slow and costly traditional clinical trials alone are no longer fit for purpose. It's time for change, but to what? Many see Virtual Clinical Trials (VCTs) as a viable approach. By combining apps, monitoring devices, social media, AI and other innovative technologies for 'site-less' research, advocates envisage VCTs delivering enhanced data collection, improved patient recruitment and accelerated results. But pharma must rethink entirely how it conducts clinical trials and invest in the necessary technology, skills and systems. The challenge for regulators is to bring forward frameworks in which VCTs can be conducted.
This is evolution not revolution, so what must pharma be thinking about now to see VCTs as a future reality? In Virtual Clinical Trials: The future of drug development? we interviewed leading VCT advocates to help you identify and evaluate where—and how—VCTs could transform clinical research and drug development.
Experts explore VCT opportunities and challenges
What our experts say…
"There are several reasons for pharma's interest in virtual clinical trials, and it depends on the individual case and what the priority might be. In my opinion and experience, the ability to accelerate trials through faster start-up and recruitment, as well as the ability to ensure data quality, are key factors. Virtual trials offer a new channel to capture data 'at source' in a more continuous and natural setting when compared to mainly capturing data during site visits. Patient convenience may also be enhanced, which can help to achieve improved recruitment and retention."
Kai Langel
Janssen
"Many safety-related events that may be caught or addressed in a site visit can be overlooked in a virtual environment. Applying the proper technologies and user education and training can mitigate this risk. For example, on one of our virtual trials the patient is asked to fill out a hospitalisation report every time they fill out their study-related forms. This allows the principal investigator to review hospitalisations for potential adverse events or serious adverse events and to act accordingly. Hospitalisation reports can be run daily, weekly, monthly, or ad hoc to help regularise access to this information."
Michael Tucker
Medidata Solutions
"Regulators will see the changing landscape and will have to come up with new regulations surrounding virtual trials. This will involve new guidelines on what data collection devices are permissible (mobile apps, chatbots, etc.), how the data is captured (eSource), and how it is stored and analysed (cloud infrastructure). The application of powerful technologies like artificial intelligence and machine learning will also create a need for newer regulatory guidelines. The end result could be a series of new guidelines of how trial data is captured, stored and analysed using the latest technologies."
Sridhar Byrappa
iClinical
What to expect
Expert contributors
The report harnesses critical insights from front line industry experts who completely understand the potential for VCTs and the key areas where pharma can benefit.
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