2023, the year of equilibrium, is upon us. Most people, processes and industries have oscillated between extremes since the pandemic began. Now is the right time to plan, achieve and sustain balance with a medium- to long-term outlook. Take clinical trials, for instance, which are on the cusp of becoming truly global, accessible and equitable.
Case in point: India is home to approximately 18 per cent of the world’s population. However, we form a meagre two per cent of the global clinical trial population. While many similar examples confirm the gaps and latent opportunities, the pandemic did bring a silver lining for the clinical trials industry.
Successfully completing the COVID-19 vaccine trials from start to finish in one year as compared to the typical seven- to 10-year timeframe was an unimaginable feat, particularly for healthcare workers who had the dual responsibility of caring for patients while trying to drive research and getting an accurate understanding about the new disease. The 3D approach of Digital, Data and Dialogue is aligned with emerging trends we are observing as we partner and engage with patients, sponsors, investigators and CROs globally.
CIOs’ evolving role and new digital transformation enablers: The new year will see a stronger coupling between clinical operations leaders and CIOs and digital transformation teams, resulting in greater collaboration and innovation in the next few years.
We are already seeing the benefits of this cross-functional amalgamation, particularly in the way digital (and data) can be leveraged to drive efficiency at a portfolio level, instead of the traditional trial-by-trial approach.
One of the best examples is through setting up a centralised control tower. Akin to an air traffic controller that captures information from varied sources, a control tower for a clinical trial can be set up to ingest data from multiple sources and stakeholders such as trial sites, patients, wearable devices, ePRO (Patient Reported Outcomes), Electronic Data Capture (EDC), Electronic Medical Record (EMR), CRO, logistics and patient recruitment; with the similar final objective of ensuring safe, smooth and timely operations.
A UK-headquartered large pharma company piloted this concept during the early onset of the pandemic. The fact that they have done a comprehensive roll-out within two years of that pilot is testimony to the success of such a model.
Establishing and leveraging unified data lakes and cloud infrastructure are strong enablers for a clinical control tower, and both initiatives are typically led by the CIO. However, transforming such a control tower – from a monitoring station to an action centre – takes the outcomes and Return On Investment (ROI) to a different pedestal by reducing the lag between insights and actions through automation.
Another initiative that aims to establish a future state of automated and dynamic readiness is underway as an industry-wide consortium at Transcelerate. Sharing and learning with other partners of this initiative has provided us a lot of promise regarding the future of drug development.
Diverse and enhanced usage of real-world data: Information silos need to be broken to leverage data and digital to our advantage. In many developed countries, anonymised insurance claims and laboratory data are commercially available for analysis. These help improve trial design, patient recruitment and operations. However, access to granular data is limited in the rest of the world. While efforts are being made to curate real-world datasets for oncology, rare diseases and other therapies, this remains one of the biggest challenges and opportunities.
Once data silos are broken, it becomes easier and more effective to deploy last-mile applications such as telemedicine for virtual trial participation, digital outreach to patients to enroll them into relevant trials, online consent for trial participation (similar to virtual KYC that many in India have experienced backed by Aadhaar infrastructure), and so on. Another key advantage of deploying the combination of data and digital is to enable afool-proof and audit-ready trail. Real-time (or near real-time) digitisation of data is one of the simplest and most important levers that can uphold the authenticity, transparency and credibility of a clinical trial.
FDA and other regulators globally have been increasingly releasing guidance to leverage real-world data for clinical trials (the latest one was in September 2022). Finding the equilibrium between real-world and trial data is going to be one of the most interesting aspects we need to keep an eye on.
Dialogues with patients: Any innovation in healthcare is incomplete without thinking about the human element, change agents and behavioural aspects.
For example, leveraging digital and social media as a patient-recruitment strategy is now table stakes. However, the manner in which one should exchange information to positively impact the psychology of patients and caregivers will remain a critical success factor. With ever-increasing scrutiny on major social media platforms ensuring a humane, empathetic, compliant yet result-oriented communication based on research-based evidence is the way forward to cut through the information overload we all are exposed to.
The farther the distance between a care provider and a patient, the greater the deterrent towards mindful and willing trial participation across countries, and racial and ethnic groups. There are many best practices that site teams and investigators can deploy at the grass-roots level, such as leveraging WhatsApp broadcast to share non-confidential awareness information (while ensuring the right privacy and data security checks and balances are in place), scheduling dedicated timeslots to see trial patients and their caregivers and leveraging compliant vernacular content to facilitate two-way communication.
Facilitating these dialogues at scale requires agility and the ability to track and manage multiple swimlanes between R&D and commercial insights for sponsors, regulators and other stakeholders. Listening to experiences, feedback and perceptions of patients, caregivers, sites, patient advocacy groups, non-profit foundations and other stakeholders is vital – so, they don’t see themselves as tools or subjects, but rather true partners in driving success together.
Much has been talked about decentralised trials. It is safe to say that hybrid trials are here to stay. It’s time for the broader healthcare ecosystem and the clinical trial fraternity, in particular, to rally together and adopt the 3D (Data, Digital, Dialogue) mindset to move the industry forward.
website is featured