In 2022, the clinical trials industry adjusted to post-pandemic reality, embracing new innovations that emerged from COVID-19. We expect many of these to continue: here we share four trends Siron Clinical will be watching in 2023 and beyond.
Looking back, it is clear to see the impact the COVID-19 pandemic had on the clinical trials industry. But in addition to the disruptions, the pandemic brought the industry unforeseen benefits in the form of accelerated innovation. Since 2020, we have seen the rise of decentralization, new and innovative trial approaches such as point-of-care trials, and virtual technologies to support aspects of trial management like remote training.
There have been many changes in the way trials are designed and conducted, and in this dynamic period for the industry, we expect to see this continue. At Siron Clinical, we work with clinical trial sponsors on a range of trial types, phases and therapeutic areas. Here are four trends we will be watching in 2023.
1. Decentralization of clinical trials will continue to grow
Decentralization has been a hot topic over the last year, with more and more sponsors embracing decentralized clinical trials to overcome some of the biggest challenges they face, such as patient recruitment.
Indeed, this was clear in a recent survey by PPD, Thermo Fisher Scientific’s clinical research business: more than half (55%) of the 150 biotech and biopharma leaders surveyed noted that a top “pain point” they face is “challenges with patient recruitment in clinical trials.”
Decentralization is part of the solution to this, providing a way to recruit participants. Respondents expected their clinical trials to be more decentralized in the future: the respondents already running decentralized trials say an additional 24% will be decentralized by 2024, and those that have not yet started expect 27% to be decentralized by 2024.
One important point to remember is that patients must remain central, especially in decentralized trials. With the growing acknowledgment that clinical trials need to be more representative, trial design should incorporate feedback from the target patients, especially about remote and tech solutions.
2. Technology will enable new approaches in clinical research
In every aspect of life today, technology is driving change. We can wear smart watches to track our steps and heart rate, talk to people the other side of the world using various apps and websites, and securely transfer everything from money to artwork using the blockchain.
These changes are having a big impact in healthcare, including in clinical research. Sponsors can choose from a growing number of platforms for data management and cloud computing, and with the increased access to information there is a bigger focus on cybersecurity. And patients are embracing the trend too: of those who wear smartwatches, over 40% already share their biometric data with their physicians.
One of the biggest tech trends we expect to see in 2023 is artificial intelligence (AI). According to Forbes, “The market for Artificial intelligence (AI) – specifically, machine learning (ML) tools in healthcare is forecast to top $20 million in 2023.” In research involving 1,499 clinical trial companies, StartUs Insights found that AI will have the biggest impact, with many using AI to automate tasks and uncover drug candidates faster.
3. Clinical trials and their data will be more transparent
At the start of 2022, we wrote about the EU’s new Clinical Trial Regulation and the associated Clinical Trials Information System (CTIS). From 31 January 2023, clinical trial sponsors must use CTIS when they apply to start a trial in the EU. Similarly, in the US, trials must be registered at Clinicaltrials.gov; by the end of 2022, more than 436,000 trials were registered.
One of the aims of trial registration is to increase transparency of clinical research. Transparency in clinical research is important for many reasons. Registering a clinical trial enables the sponsor to fulfil their ethical obligations, provide information to those who need it, such as participants, and help ensure research funds are allocated effectively. And publishing the data provides a public record of the research and helps build our collective medical knowledge, as well as reducing the risk of duplication.
With the increased use of the new EU system from January, we expect transparency to become even more important in the future.
4. Sponsors will increasingly look for support
This is an exciting time for clinical trials, with innovation, technology and accessibility changing the landscape. But trials are also becoming more complex and bigger, providing sponsors with challenges spanning regulation, project management, medical monitoring and more.
In the PPD survey, 47% of clinical trial leaders said they were more likely to outsource some trial activities to a CRO, and 35% would outsource all activities. A CRO can support a trial at every stage, from design to data publication – here are five reasons you don’t have to do everything yourself.
Looking forward to a successful 2023
We look forward to working with you in 2023 and beyond, to run clinical trials that continue to evolve, deliver useful results and meet patients’ needs. We wish you a peaceful holiday season and a bright and prosperous New Year!