Replacing manual and paper-based procedures with digital solutions is now a question of “when” and not “if.” Here are the key reasons why pharmaceutical companies should speed up adoption of digital innovations for clinical trials.
The clinical trials market itself is growing – Maximize Market Research (MMR) estimates its value at $48.7 billion in 2022 and forecasts that by 2029, the market will be worth nearly $78.3 billion.
There are two major market drivers contributing to the growth of clinical trials:
- Increased focus on patient safety and heightened requirements for drug approvals
- A growing demand for new drugs, especially for chronic disorders (e.g., cardiac), cancer, and gene therapies
With the average trial costing around $19 million (again, MMR estimations), pharma leaders don’t have much wiggle room – they need to find ways to make clinical trials more effective. They need trials set up and conducted quickly, with high accuracy, enhanced with real-time data analysis.
Current challenges in clinical trials
Traditionally, clinical trials have been burdened with paper-based processes – time-consuming and prone to human errors. But the analog approach has further-reaching consequences.
When asked about the current main challenges in clinical trials, Iris Loew-Friedrich, Chief Medical Officer for UCB Pharma, shared these three:
- Recruitment and retention of participants
- Ensuring diversity in clinical trials
- Data management and analysis
By design, any clinical trial run in an onsite facility faces a limited pool of eligible participants. Keeping enrolled participants engaged throughout the whole process – well, that’s another story.
To give you some perspective: patient recruitment is considered the main cause of delays in kicking off a clinical trial, and about one-third of trial failures are because of this (source: Using digital technologies in clinical trials: current and future applications).
Diversity is important, not just for ethical reasons. The impact of treatment and the side effects can vary depending on age, sex, and ethnicity. According to Scientific American, in some clinical trials in the US, 80 to 90% of participants are white, whereas around 40% of Americans belong to a racial or ethnic minority.
Finally, the data.
Pharmaceutical companies are dealing with increasingly more data: clinical, genomic, data from wearable sensors and devices, electronic health records, etc. What’s more – to quote the Chief Medical Officer for UCB Pharma again – the data is being “collected from disparate sources using a variety of means.”
This challenge is unlikely to go away – reports suggest that up to 70% of clinical trials will incorporate wearable sensors by 2025.
How digital solutions can boost efficiency in clinical trials
In a poll conducted by Verdict in 2021 to assess the benefits of digital clinical trials, most of the respondents indicated improved data collection (24%) and enabled remote monitoring of patients (21%) as key advantages.
Other benefits mentioned were: cost-savings; continuous and passive monitoring of patients; improved patient retention; patient recruitment; and reduced burden on staff.
Let me zoom in on them briefly.
Enhanced Data Quality: Digital solutions provide sophisticated data capture technologies that reduce errors associated with manual data entry, leading to higher quality and more reliable data.
What’s more, using AI on larger datasets can help pharmaceutical leaders find insights and patterns with comorbidities that were not spotted before – this may improve a lot of things, including treatment selection.
Real-time and Remote Monitoring: Digital platforms allow for real-time data monitoring, enabling trial managers to make informed decisions quickly and to identify and address issues as they arise.
Think of this change as going from getting only snapshots of data (we know the state of a patient's health at a given point in time) to collecting continuous data on how the patient is reacting to the treatment throughout the whole trial.
Cost Savings and Increased Efficiency: By streamlining various trial processes, digital solutions can help lower operational costs, such as those associated with data collection, storage, and analysis. On top of that, automation of processes and workflows through digital solutions can significantly reduce the time spent on administrative tasks, thus speeding up the entire trial process.
Improved Participant Engagement: Digital tools can facilitate better communication with participants through reminders, updates, and feedback loops, enhancing retention and compliance. The NIH and NSF recognize digital clinical trials for their potential to transform clinical trials by improving participant access, engagement, trial-related measurements, and interventions.
Broader Reach for Participant Recruitment: Digital platforms can expand the reach of clinical trials by facilitating remote participation, which is particularly beneficial for reaching diverse populations or those in remote locations.
While Cambridge Analytica proved it’s possible to leverage profiling through social media to influence voters, we can imagine using AI and social media for a good cause. Combining new tech and marketing tactics, pharmaceutical companies can not only build awareness of clinical trials but also identify gaps in representation and offer strategies to recruit diverse participants.
Better Compliance and Audit-readiness: Digital solutions improve compliance with regulatory requirements by maintaining thorough and traceable records, thus ensuring that trials are always audit-ready.
Improved Medication Intake Administration: Digital tools provide a reliable method for monitoring patient adherence to medication schedules, which is critical for the integrity of trial results. What’s more, they help improve dosing accuracy and send timely alerts and reminders to patients to take their medication at the prescribed times, increasing the likelihood of adherence.
Personally, this is one of my favorite benefits of introducing digital to clinical trials, as it leads directly to patient empowerment – by giving patients more control and visibility over their medication schedules, these tools can increase their engagement and investment in their own treatment plans.
Our healthtech team at Netguru tackled some of the challenges recently while validating our idea for the future of Alzheimer’s care.
Within six weeks, we created NeuroNest, a combination of a clickable application prototype with a proof-of-concept digital therapeutic platform that supports Alzheimer’s disease patient care.
Digitalization of clinical trial procedures: A leap towards efficiency and engagement
The integration of digital technologies into clinical trials is a necessary evolution to overcome the complexities of modern medicine and drug development. Digitalization promises to streamline these processes.
The regulatory landscape is also adapting. It is now more accepting of digital methodologies – starting from telemedicine and remote monitoring, through to AI and blockchain technology.
Blockchain is particularly interesting, as it offers a secure, immutable record-keeping solution that can bolster the integrity of trial data. We’ve leveraged this technology in a different context – we built a blockchain-powered web platform for the cannabis market for Merck, where users can now receive, upload, and share COAs (Certificates of Analysis) in a secure, tamper-proof way. But that’s another topic.
To wrap it up, the global shift towards digital health, accelerated by the pandemic, has opened up new possibilities for clinical trial management. For sponsors and investigators, streamlined workflows can lead to substantial cost savings and quicker time-to-market for breakthrough therapies. For patients, engagement and retention in trials could see a significant boost thanks to the convenience and accessibility of digital tools.