The Impact of Digital Transformation in Clinical Trials

Recently updated

The pharmaceutical sector is always changing. With the pandemic increasing people's awareness and worry about their health on the one hand, but simultaneously avoiding hospital visits unless absolutely essential, digital/eClinical is becoming a more and more popular tool of healthcare delivery.

Clinical trials are one example of a field where digital is the new mantra. By digital transformation at various phases of clinical trials, pharmaceutical companies/sponsors may recruit and retain more participants while also gaining greater insights through data analytics. Participants stand to gain from the digital features as well since the trial becomes decentralized and self-assessment becomes easier, providing them with greater freedom, personalization, and precision.

Are the Opportunities for Digital Trials significant enough?

The global market for virtual clinical trials is expected to grow at a 5.1% CAGR from $7.4 billion in 2020 to $10.5 billion in 2027, owing mostly to growth in North America and the cancer sector. Government assistance and increased competition will boost the adoption of innovative technology for clinical research in the United States. Because of its enormous patient pool, among other variables, the Asia Pacific area has the greatest anticipated CAGR (6.2%).

By April 2020, it appeared that more than half of research locations were turning to virtual patient engagement approaches. An examination of the clinical trial database reveals that, despite the initial interruption, the number of industry-funded clinical trials launched following the COVID-19 outbreak grew dramatically. The number of research launched in the fourth quarter of 2020 was 32% greater than the previous year, while the number of publicly sponsored studies increased by 28%.

When you say digital trials, do you mean no in-person engagement at any point throughout the trial?

Decentralized Digital Trials (DCTs), on the other hand, necessitate no required trial site visits thanks to digital data capture and other technologies. DCTs are described by the FDA as the decentralized operation of clinical trials in which technology is utilized to connect with study participants and gather data. In short, everything is virtual, including study start-up, patient enrollment, patient care, data collecting, testing, imaging, and results. All clinical trial operations are controlled centrally, and there is no interaction between patients and caregivers — simply data transfer.

While the preceding two are at opposite extremes of the spectrum, Hybrid Trials are currently the most common and recognized kind of digital testing. Faced with the urge to reap the benefits of virtual trials while also performing some treatments on-site, sponsors have turned to hybrid designs as the best of both worlds. By the use of technology and techniques that enable virtual trials, these studies enable sponsors to dramatically reduce the number of sites and the frequency with which patients attend them while still having physical locations to execute specific operations.

Not always. Virtual trials do not need to be completely digitalized.
Conventional clinical trials required visits to the researcher's trial location at each stage of the experiment. If no technology interventions are used, the entire process might take years and often involves the participation of hundreds or thousands of individuals.

The pandemic suspended or interrupted 80% of studies unrelated to COVID-19. A month following the outbreak, up to 80% of clinical trial subjects refused to attend visits on-site.
The US Food and Drug Administration released recommendations urging sponsors and researchers to assess whether it would be beneficial for study participants to continue participating in a trial or not and encouraged the use of virtual alternatives. During the pandemic, virtual consultations and eConsent were the most commonly used technologies.

PPD, a leading global pharmaceutical contract research organization (CRO), has found that DCTs resulted in:

• 30 – 50% reduction in recruitment timelines

• 90% increased trial retention rates

• 97% increased patient interest

• 30 – 60% of patients recruited from communities of color

• 79% of study team members believe that data quality can be higher

With decentralized trial capabilities accelerating, manufacturers predict only 41% of clinical trials will be traditional, onsite trials in 2023. The other 60% will be either hybrid or completely virtual and decentralized. Manufacturers are expected to continue outsourcing parts of their trials to CROs in the short term until they build internal capabilities like an EDC digital platform for hybrid and decentralized trials.

J&J recently announced that the majority of its studies for its FDA-approved single-dose COVID-19 vaccine were conducted digitally. 

Pfizer is combining real-world data with clinical data to gain a better understanding of patient outcomes. They're also automating tedious operations and using artificial intelligence to make better decisions. 

Overall, pharmaceutical companies are doing more digital trials than ever before, although the number is still small.

The most difficult difficulty that conventional clinical trials encountered was budgeting, with the number of patients necessary to prove the effects of a medication being the biggest cost driver, followed by the number of clinic visits, which ranged from 2 to 166.3. Another key challenge for researchers is having an efficient digital data capture system and patient recruitment and retention. 8 out of 10 studies fail to recruit enough volunteers on time, resulting in delays.

Just around 10% of the initial volunteers in research finish them effectively.