Digitalisation of the clinical trial landscape

With the adoption of digital technologies gaining traction in many industries, pharmaceutical companies must take advantage of digitalisation within its research and development (R&D) sector. A fundamental part of the R&D process, clinical trials hold great potential in advancing the field — as long as these digital innovations are implemented. 

According to Maximize Market Research, new technologies are expected to boost the clinical trials market between 2022 to 2029, especially as the industry and patients are shifting towards digitalisation approaches and personalised medicines.

In this Q&A, Iris Loew-Friedrich, Chief Medical Officer for UCB Pharma shares her perspective on clinical digitalisation, data standardisation and the future of clinical trials.

What are the current three main challenges in clinical trials? How can virtualised trials/AI/digitalisation help to address these challenges?

While clinical trials play a pivotal role in advancing medical knowledge, the landscape is not without its challenges. In the pursuit of scientific progress, we as an industry face several hurdles, including recruitment and retention of participants, ensuring diversity in clinical trials, and data management and analysis.

Finding enough eligible participants and ensuring their continued engagement throughout the trial can be difficult due to a range of reasons such as logistical barriers, lack of understanding of clinical trials and a limited pool of eligible participants. Virtualised trials, which utilise remote and decentralised approaches can expand the reach of clinical trials and enhance participant recruitment.

By eliminating geographic limitations, virtual trials can access a larger pool of potential participants. With a move to hybrid clinical trials, whereby we combine the best of traditional clinical trial elements with the benefits of a remote model, we can increase trial recruitment. Using digital means we can streamline communications, facilitate better patient engagement, and ultimately improve retention rates.

Historically, certain demographics such as ethnic minorities or the elderly have been underrepresented in clinical trials. However, the integration of artificial intelligence (AI) can play a crucial role in tackling this disparity. AI has the potential to identify gaps in representation and offer strategies to promote diverse participation. By incorporating a more comprehensive range of individuals in clinical trials, researchers can obtain valuable insights into the efficacy and safety of drugs across various populations. Using real-world data and social media content, AI can identify eligible participants from diverse populations, considering factors like demographics, health records, and genetic information.

Increasingly we are dealing with more data, collected from disparate sources using a variety of means. This brings a multitude of challenges in terms of how we manage and analyse this data. Digitalisation and AI can greatly enhance data management and analysis in clinical trials. Electronic data capture (EDC) systems can streamline data collection, reduce errors, and enable real-time monitoring of trial progress. The partnership between UCB and Microsoft has allowed us to explore how to combine diverse data sets and biology within clinical trials, synthesising the information to help make faster, data driven decisions.

Why R&D innovation holds the key to greater patient impact

What are the top two benefits of a single digital clinical data library?

In the context of an increase in virtualised clinical trials and the use of AI, combining data assets to form a single digital clinical data library has several benefits, particularly in the realm of safety data. The consolidation of extensive data into a centralised repository enables enhanced identification of adverse drug interactions, rarer side effects and differences in response among diverse patient populations. By combining larger datasets, novel insights into underlying comorbidities can emerge, influencing clinical decision-making, treatment selection, and the interpretation of safety data in clinical trials. This approach facilitates a comprehensive understanding of medical information and enhances the management of patient care.

By having a single library that holds clinical data, researchers can retrieve relevant patient data and historical information easier than they ever have before. This can lead to faster access to information, reduce the need for large cohorts and therefore an acceleration in progress in medical research. With the aim to create further personalised care for patients, enhanced research collaboration through a single digital clinical data library can foster innovation, accelerate scientific discoveries, and facilitate the development of personalised and precision medicine approaches, leading to patients’ unmet need being met quicker.  

As the data landscape evolves, what is the most exciting innovation in clinical data management. Why?

The evolution in the way we collect and access data as well as the increasing scale and diversity of data is creating the most profound change. This does present challenges, but we should focus on the exciting opportunities.

To ensure that the benefit of a treatment outweighs the risk for the patient, we need to have access to both clear evidence of efficacy and a robustly defined safety profile for the drug being prescribed. By combining various types of data in a safety-centric manner, including clinical data, genomic data, wearable device data, and electronic health records, researchers can create comprehensive profiles of patients participating in clinical trials. This can therefore help in making better data-driven decisions about the risk benefit of treatments.

We will be able to collect more detailed continuous data rather than just a series of snapshots in time, allowing us to create more personalised and detailed assessments of the true effects of the therapies under study. The use of technology should make access to clinical trials easier and so enable recruitment of more diverse study participants. This holistic view has the potential to enable a deeper understanding of patient characteristics, treatment responses, and potential factors that influence outcomes. It allows for personalised medicine approaches, where treatments can be tailored to specific patient subgroups based on their unique profiles.

For organisations looking to standardise the measurement of safety data, what approach is the most impactful?

Standardisation of safety data is essential to ensure consistency and robustness of data collected across different protocols, across different site and across studies. To leverage the emerging technology it will be important to have a standardisation that is as broadly accepted as possible. Apps validated by independent scientific groups, approved by regulators and usable across all clinical studies, could mean that that emerging clinical study safety data can be collected and made accessible in real-time.

This offers opportunities for enhanced oversight and more agile decision making. If we can standardise data collection, we will have the option to run larger and more complex studies. It will allow trials to be larger and simpler and so provide datasets that are big enough to assess the rarer medical events, reduce the use of placebo and enable more rapid switching of patients to the most effective or most tolerated therapies under study in a particular disease. This is already beginning to happen, but the opportunities will continue to grow and become more standard practice.

Organisations also need to be intentional and data driven in deciding what types of safety data to collect and the more this and the analyses can be standardised, the more the burden of the clinical trial can be reduced for both patients and clinical sites.

What area presents the biggest challenge when standardising the measurement of safety data?

Disparate data continues to be a concern for the pharmaceutical industry since the clinical trials landscape changes constantly with various integrations. and data collectors may alter so quickly. While there is flexibility and variety of mixing data sources, such as wearable technology to record patients’ vitals, patient reporting of symptoms, HCP observations, and several other data collection methods, standardising the assessment of data that is collected via apps and medical devices is challenging.

Clinical trial design has evolved to minimise bias and this has mostly been done by controlling for external variables and standardising the way data is collected. The new apps and devices may provide lots of data but the environment and conditions at the time the data is collected will be less controlled. Thus, the data we collect in this way may have an inherent lack of standardisation. This combined with the challenge of defining when something is outside the range of normal variability may initially create a significant challenge. While challenges in the evolution of clinical trials and data poses difficulty in the short-term, it provides us a closer step to fast-tracking the development of innovative solutions for patients.

How can organisations best work with regulators as the clinical landscape evolves?

Fostering an environment of collaboration is vital to have a fruitful relationship with regulators. Organisations can collaborate with regulators by sharing scientific knowledge, research insights, and best practices. There are already many opportunities for organisations to have these discussions and the inclusion of leading clinicians and patient experts further strengthens the value and impact that we can all have together. The development of the COVID-19 vaccines was a great example of how collaboration between regulators, organisations, clinicians and patients was able to bring impactful results in record time.

In a rapidly changing landscape, particularly when it comes to how we capture and analyse data, organisations should proactively seek regulatory input, discussing potential challenges or uncertainties. Organisations can establish open lines of communication and build mutual trust, as well as ensuring that they stay updated on evolving regulations, guidelines, and best practices in the clinical research field.

By maintaining a thorough understanding of regulatory requirements, organisations can ensure compliance, and proactively address any changes or updates that may impact their operations. We should also take every opportunity to share proposals that reduce the impact of clinical trials for study participants and where we see opportunities to speed up access for patients to innovative therapies.

What do you anticipate clinical trials will be like in five to 10 years?

The goal is for a clinical trial to successfully and safely deliver innovative therapies that benefit patients’ lives. The aim is to do this in a way that is not burdensome for study participants or study personnel and delivers good medical care at the same time. This is becoming an achievable reality with the significant scientific advancements in recent years and the technological opportunities that are emerging.

I believe the most exciting prospect is the integration of electronic records and the seamless integration of trials into clinical care or the ‘invisible clinical trial’. After of course gaining patient consent, the treatment journey of the clinical trial could be followed as an integrated part of their healthcare journey through direct access to their electronic health record (EHR).

This integration not only enhances patient access to novel therapies, but would also provide a comprehensive, real-time understanding of the safety and effectiveness of emerging treatments. Moreover, it brings substantial value in post-marketing surveillance by enabling closer monitoring of recently approved therapies with minimal disruption to patients and healthcare providers. Looking ahead, we envision a future where clinical trials and research seamlessly merge into the healthcare continuum and patient journey, creating a holistic approach that maximises the benefits of medical advancements for patients with the ultimate goal of allowing patients to live the lives they wish to lead.

About the interviewee

Iris Loew-Friedrich is Chief Medical Officer for UCB Pharma, a member of the company’s executive committee, and head of development solutions. She provides strategic global leadership for worldwide clinical development, medical affairs, regulatory affairs, quality assurance, statistical innovation, real-world evidence, and patient safety/pharmacovigilance.

Catherine Eckford is Editorial Assistant at European Pharmaceutical Review.