For years, the prospect of ‘virtual’ and decentralised research was discussed with hope as a potential disruptor to enable greater patient access and engagement for medicines development and reimbursement.

While discussions were often marked by more hype than action, by 2019, digital and virtual models were being adopted across a range of clinical, late phase, and real world research settings. Indeed, according to an article in the British Medical Journal, over 1170 studies starting in 2017 included the use of digital products to facilitate remote data collection. As providers of a real world late phase platform, we have directly seen the hype translating into concrete action.

With this model, one size does not fit all. As a McKinsey report recently highlighted, there is a continuum of digitisation ranging from traditional and fully centralised approaches to completely virtual models. An entirely virtual approach would manage all data collection outside conventional settings. On the other hand, decentralised or hybrid models make only specific elements of research activities virtual. For example, remote patient visits, electronic patient reported outcomes (ePROs), and eConsent are now viable through validated technologies, for example, Baseline Plus.

The benefits of adopting decentralised and virtual strategies have been clear for some time, standing to increase efficiency and reduce the costs of connecting with patients and generating evidence across the product lifecycle.

Increasing demand for real world research and late phase data capture

With this promise of benefit and a solid technological foundation in place, it seemed that even pre-2020 virtual and decentralised research was set for increased, if not entirely mainstream, adoption. Yet, no one could have anticipated how dramatically the COVID-19 pandemic would change the scene and accelerate the momentum towards non-traditional research models for sponsors and CROs alike. With restrictions on travel disrupting centralised research, coupled with a pressing demand to generate real-time data and insights at speed to tackle COVID-19 itself, CROs and sponsors have had to embrace innovation more than ever before. Many have now significantly adapted to bring emerging and disruptive approaches to the heart of their strategies. The result has been a paradigm shift.

First, the adoption of virtual and decentralised research has accelerated beyond expectations. In our business alone we have seen requests for studies increase by more than 150% versus the same period 12 months before. According to McKinsey, the pandemic has seen a sustained, 3-fold increase in remote patient interactions. At the same time, a recent study by GlobalData found that 67% of survey participants indicated that they plan to use decentralised approaches in the future. In tandem, there has also been a boosted drive to answer pressing research questions and tackle the pandemic through real world research and observational methods. At Cisiv, we cover a full range of late phase research, from starting a managed access program, through to the end of long term follow up studies. Across this entire spectrum, we are seeing an increased uptake in our remote consent and direct from patient data collection.

Developments in the real world and late phase market as a result of the pandemic

While the pandemic has acted as the initial catalyst, it seems inevitable that the increased prevalence of remote data collection, decentralised research and RWE generation will continue beyond the crisis and yield new efficiencies and improvements. In fact, learning from the pandemic has already begun as we have witnessed the following developments in the marketplace:

• Increased breadth of study types being requested by pharmaceutical and biotech companies and the need for flexible technology to deliver these studies.
• A desire to engage both physician and patient within late phase real world studies, combining retrospective and prospective studies to answer key questions.
• Technology that is easy to use to accommodate often novice physician and patient users.
• Demand for technology solutions that can integrate seamlessly with Electronic Health Record systems, extract the data, and engage the patients in a prospective study.
• Robust, credible technology platforms, that can underpin remote models and are flexible enough to meet the needs of any given protocol.

To keep pace with this evolving paradigm and increasingly technology enabled research, CROs have had to reconsider their roles and re-engineer their operations. This response has included increased investment in technologies to support decentralisation and repositioning to the market as digital innovators. Our engagement with CROs has evolved over the last 18 months in a way that significantly advances how we develop and build studies to support our sponsors.

It is telling that the trend has featured in the latest rounds of CRO news announcements and investments. For example, new investors in Parexel specifically highlighted the success of the CRO in adapting to new pandemic ways of working. Certainly, larger CROs may have been initially well placed to capitalise on an existing foundation of technological development, experience in hybrid and decentralised approaches, along with established presences in observational and real world studies. However, there remain opportunities for smaller and mid-sized CROs to adapt and respond to this transformed landscape. The rise of specialist smaller CROs which focus on specific areas, for example, health economics, provides dedicated expertise which can be advantageous.

Cisiv’s Baseline Plus offers the only purpose built platform designed for late phase and real world studies with the ability to tailor to decentralised as well as centralised research. It provides a simple, intuitive experience for all users and accommodates the needs of study team members, HCPs, and patients themselves. Bringing together EDC, eConsent, ePRO, eDiary and eCOA in a single platform, it simplifies oversight and management, while allowing the flexibility to tailor an approach to the specific protocol requirements.

While the last 18 months has undoubtedly been a time of adversity for CROs and sponsors, it also represents an opportunity for the industry to capitalise on innovation and improve productivity. At Cisiv, we are committed to supporting organisations with the tools to shift towards more real world, decentralised methods of data collection, and create a more efficient research paradigm that meets physicians and patients where they are.