Virtual Clinical Trials: The future of drug development?

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 are the perceived benefits that are driving pharma's interest in VCTs?
What does pharma need to do to make VCTs a success and will virtual studies ever replace traditional models of research?
How ready is pharma for VCTs in terms of possessing the research and technological capabilities and tools to go "site-less"?
Will VCTs be applicable at all stages of a drug's development, and if not, why not?
Are VCTs more appropriate to specific diseases or patient types?

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

A detailed report exploring how VCTs could radically improve speed and quality of clinical trials and the significant design, technological, organisational and regulatory hurdles that must be overcome.
An examination of 8 key issues that drug developers need to understand and respond to.
16 targeted questions put to VCT advocates.
Their perceptive responses that provided 71 insights supported by 79 directly quoted comments.

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.

>Michael Tucker is the Senior mHealth Specialist at Medidata Solutions, USA, where his focus is reengineering clinical trials to solve the challenges of patient engagement and data collection from research volunteers in a virtual environment. Tucker has been instrumental in advancing Medidata as a technology provider that is dedicated to transforming clinical research for life science companies and the patients who depend on them. Prior to his role at Medidata, Tucker was the Director of Business at Mytrus, an eClinical technology provider, which was acquired by Medidata in 2017. A veteran of the medical research, software, and technology industries, Tucker has served in executive management roles in business development, sales, and client services for nearly three decades. He has been instrumental in the management of venture capital, private capital and corporate equity funded start-ups since 1995, guiding organisations from product inception to acquisition.
Kai Langel is the Director of R&D Operations, Clinical Innovation, Janssen, Spain, where his role is to lead transformative innovation initiatives in clinical R&D, focusing on digital health and remote/virtual clinical trials. Prior to his engagement with Janssen, Langel was the Co-Founder and Director of Patient Solutions at eClinicalHealth and a key player in the development of Clinpal, an innovative cloud-based digital patient recruitment and engagement platform.
Sridhar Byrappa is the Co-Founder and CEO of iClinical, USA. iClinical is a mobile/cloud-based clinical trial data collection and analytics platform designed for use by pharmaceutical companies, medical device companies, contract research organisations, and academic researchers. Byrappa's goal in founding iClinical was to leverage artificial intelligence and machine learning technologies to automate and speed up drug trials and bring life-saving interventions to patients faster and with better evidence than the current frameworks allow.

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Virtual Clinical Trials: The future of drug development?

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