Trial blazing

‘Digitisation has delivered an abundance of data. If the last phase of progress was gaining this data, the next phase is surely to refine and manage it’

More organisations are rolling out pilot programmes, implementing hybrid trials more extensively and overall delving deeper into decentralisation to explore the benefits it offers. Regulators, too, are increasingly on board, especially in light of the increased diversity of patient populations that decentralised clinical trials can bring, which is a key strategic focus in the industry.

As ICON’s Head of Decentralised Clinical Trial Solutions, I recently participated in a panel discussion on ‘Drug development – Digitising, decentralising and accelerating R&D’ at the Financial Times Global Pharma and Biotech Summit.

These conversations are really constructive to exchange ideas and drive the evolution forward. I shared the stage with representatives from the industry to discuss how far decentralisation has come, where it stands and where we are heading. In this article, I share my reflections on that conversation, in addition to my thoughts on the latest progress in decentralisation, patient retention and economic considerations.

Make no mistake, digitisation has delivered an abundance of data. If the last phase of progress was gaining this data, the next phase is surely to refine and manage it.

As an industry, we need to turn away from simply capturing as much data as possible and focus instead on evaluating the most relevant, highest-impact data points. We also need to determine how and when to collate that data most efficiently and seamlessly to answer the scientific question.

During the panel session, we discussed some advancements in tokenisation and linking clinical trial data to real-world data in order to provide additional insight into the patient journey, while also maintaining the data’s anonymity and integrity.

This has opened possibilities for more passive long-term follow-ups for certain trials, which could reduce the overall cost of drug development. It also offers other opportunities to enrich patient insight and, ultimately, more effective treatments for patients.

Amid this backdrop of enhanced data refinement, the expanding digiverse of remote data collection tools for use in clinical trials has facilitated improved endpoints and new patient-centric insights through richer data and, hence, the capability to design trials that really meet the patient profile.

The collection of layered technology and applications that sponsors must manage, however, can be cumbersome. Engaging various platform vendors can leave gaps in the R&D continuum, which results in increased complexity in operations and time spent on managing multiple vendors.

To reduce site and investigator burden in decentralised clinical trial models, the industry is turning to integrated platforms to streamline data integration and processes. For example, digital platforms that can be customised to fit the needs of each study, streamline the overall technology processes and provide an integrated single-interface for sponsors.

As we move to integrated digital solutions, we can reduce the burden on sites and investigators, especially in decentralised clinical trials, while supporting patient-centred outcomes.

In any clinical trial, be it decentralised or otherwise, the priority is always the patient. We conducted a patient voice survey last year to better understand current patient attitudes toward decentralised or hybrid trials.

The results reinforced our 2019 survey findings that patients are open to decentralised clinical trial approaches, but overall, they want the options and flexibility they provide. This feedback supports our view that the situation is not black and white – optionality is key.

Decentralised clinical trials overcome two common hurdles for patient recruitment and retention – accessibility and convenience. Typically, patients that participate in clinical trials live within 50 miles of the site. In the 2021 survey, we found that 90% of respondents were not willing to travel more than one hour to participate in a clinical trial.

The physical parameters and burden of travel associated with traditional trials exclude significant populations of patients that are either incapable or unwilling to travel to the site. Providing hybrid and fully decentralised clinical trial options eases the burden of travel and delivers a more positive and convenient patient experience.

Being vigilant in reducing patient burden is key to retention, especially in decentralised trials where the flexibility of decentralised methods and technology can potentially replace one challenge with another, for example, using the technology devices themselves.

That is why staying close and supporting patients is vital. Direct inbound and outbound communication with patients improves overall engagement, compliance and retention throughout the trial by onboarding the patient and being a central contact for any challenges they might come up against. Customised patient programmes ensure the support is aligned to the patient profile and challenges, expected in the disease or indication.

In my role, one of the questions I am asked most often is around the cost implications of decentralisation – does it add costs or reduce them? It is difficult to assess economic value across the board, as decentralised components deployed vary between studies and across phases. Costs during start-up can shift from the set-up of sites to technology. We do know, however, that financial benefits are more likely to come to fruition through accelerated or reduced overall timelines and positive results in areas such as patient recruitment and retention.

The operational efficiencies of decentralisation offer opportunities to reduce time schedules and drive economic benefits. A recent Tufts CSDD Impact Report found that clinical trial timelines were reduced by approximately 10% when decentralised methods were applied across phases 2 and 3. Reduced trial length contributes to an average of 6.81 ROI for clinical trials when implemented over phases 2 and 3.

The Tufts report provides an important benchmark for the industry to discuss the economic impact of decentralisation on clinical trials, but it’s challenging to create a baseline. In our discussions with clients, we walk through value-driving metrics like patient diversity, recruitment speed and retention, improved compliance to protocol and the enhanced integrity and commercial value of the data collected.

The conversations like those at the FT Global Pharma and Biotech Summit reflect the progress we have made as an industry in developing better, faster, more patient-centred clinical trials and – pivotally – getting life-saving medicines on the market.

Drug development is a complicated process, but our latest progress in the area has created more inclusive and accessible trials that deliver higher quality insights quicker than before and with better potential returns on investment. As we continue to engage, we will drive innovation and set new benchmarks for evaluating the success of decentralised and hybrid trials.

Harpreet Gill is Vice President, Decentralised Clinical Trials at ICON. Go to iconplc.com