It’s somewhat ironic that at a time when we’re in desperate need of a COVID-19 vaccine and clinical trials have become more important than ever, it’s more difficult to conduct them—by traditional means, at least. Largely due to social distancing measures and travel restrictions, nearly 80%¹ of sites have had at least one clinical trial put on hold or cancelled recently. Yet COVID-19, the apparent ‘spanner in the works’ for clinical trials, is now the catalyst pushing more trials to be conducted virtually—enabling more innovative approaches to trials and improving the patient experience. The use of virtual trials will surge in the future and could become the de facto standard for clinical studies. Indeed, a recent Pistoia Alliance poll found more than half (55%) of life science professionals believe a quarter of all trials will be conducted virtually within one year.

While COVID-19 has accelerated implementation of virtual trials, the underpinning technology has been coming to the forefront of research for some years: including patient wearables, smart monitoring and sensors, apps for collecting data, plus cloud and automation. We will also see virtual and augmented reality become a feature in years to come. However, digital tools can’t be adopted without careful thought. They collect large volumes of data, and since there is a lack of stewardship (i.e. agreed metrics and standards for managing information), usage is limited. For virtual trials to deliver value, the industry must ensure they support the longer-term aim of making patients’ lives easier—which should be a priority whether COVID-19 is in the picture or not. So how can these obstacles be overcome, and how can we ensure virtual trials bring benefits to clinicians, sponsors, and most importantly, patients, while bringing therapies to market faster? The answer lies in collaboration and it is our mission at the Pistoia Alliance to help drive innovation through collaboration.

Virtual ventures

Firstly, it’s important to understand why virtual trials have risen to prominence recently. Perhaps most important is logistical convenience for patients; digital tools like wearable smart devices mean data can be collected at home, meaning fewer (or even an absence of) time-consuming site visits. Data can also be captured virtually at any time, which not only shortens the processing time for clinicians and sponsors, but patients can access their own data easily and securely. Remotely-captured data is usually stored not on at-home devices, but on an encrypted platform, and alongside patients’ ability to input data themselves in a simple format, brings all-round convenience—and means data collected is closer to the real-world experience.

Non-contact trials also allow for a more diverse set of participants to be recruited. This is particularly crucial for trials where a very targeted group of candidates is required but the patient population is geographically dispersed. Whereas contact-based trials would limit the pool of patients able to take part, conducting them virtually means patients can be recruited from anywhere. These factors together help improve trial compliance, ensuring the process is simple enough to take part so that fewer participants withdraw. Many companies have found this out for themselves; R&D solutions provider Zifo², for instance, recently conducted a virtual trial for a prophylactic COVID-19 treatment in India. By using live dashboards to communicate information and send automated reminders to patients to collect data, the company could help ensure greater trial compliance.

Roadblocks to success

So, what are the barriers preventing benefits being more widely realized? The issues are largely around data—while remote tools for home measuring have advanced in capability, many cannot adequately capture and record patient information. This is partly because of a lack of agreed data metrics and standards; a recent poll conducted by the Pistoia Alliance found nearly half (46%) of life science professionals believe a lack of industry-wide standards is the biggest barrier to collecting and leveraging patient data in the quest to support digital health. Without standards, the way information is collected during virtual trials won’t be consistent, seriously impacting data’s usability and interoperability.

There’s also the fact that pharma companies and sponsors often have their own sets of systems and safety tools, which aren’t always able to operate seamlessly. Electronic data capture (EDC) systems, for instance, are uniquely configured, and in many cases the data they record cannot be easily exchanged and shared between stakeholders during contact-based trials—so adding newer, remote monitoring tools to the equation only deepens the problem. This is why to date, many organizations are talking about using digital to conduct virtual trials, but rarely delivering tangible outcomes.

Collaboration, collaboration, collaboration

With so many stakeholders involved in virtual trials, the industry must come together to ensure these hurdles can be overcome. The targets must be:

• Establishing consistent data stewardship: With such a vast variety and quantity of data being generated from digital tools, the industry must commit to standardization. By ensuring information is captured, recorded, and stored consistently, it can be shared more easily across the different eco-systems. For example, AstraZeneca has recently spoken³ about using tools from Veeva to accelerate information exchange across stakeholders throughout the clinical trial process.
• Cross-discipline collaboration: For virtual trials to bring therapies to patients faster, sponsors, tech vendors and biopharmas need to share processes and best practices. As digital technology becomes more prevalent in clinical trials, this means problems they encounter can be overcome together, using shared expertise and interoperable tools.
• Ensuring patient-centricity: With so many organizations keen to label their approach to clinical studies as virtual without actually pushing the boundaries, its important stakeholders don’t simply jump on the bandwagon, but ensure virtual trials are carefully planned with participants’ interests in mind and conducted with the primary aim of producing better outcomes for patients.

COVID-19 has shown an institutional acceptance of virtual trials, but this growing eagerness to get behind them must be balanced in favor of patient wellbeing. The aim should not be to make trials 100% virtual, but to introduce digital tools that can be used remotely to bring drugs to market faster, more conveniently and with greater trial compliance. To ensure these goals are met and virtual trials can become mainstream where appropriate post-COVID-19, cross-discipline collaboration across the various clinical eco-systems will be essential.

The Pistoia Alliance’s Virtual Conference Week running 19-23 October 2020 is free for anyone in the industry to attend and will be shining the spotlight on digital health and improving patient outcomes. Full details of the keynote speakers and registration can be found here: https://www.pistoiaalliance.org/eventdetails/pistoia-alliance-virtual-conference-2020/?utm_source=Article&utm_medium=PR%20publication&utm_campaign=Digital%20virtual%20trials​

Professor Ashley George is the Co-Founder of The Pistoia Alliance.

References

1. https://www.businesswire.com/news/home/20200408005743/en/​
2. https://www.zifornd.com​
3. https://www.veeva.com/resources/veeva-announces-vault-site-connect-to-automate-information-sharing-in-clinical-trials/​