How Regulation and Technology Impacted Clinical Research in 2023
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How Regulation and Technology Impacted Clinical Research in 2023

by | Dec 20, 2023

This has been a year of change in the clinical trials landscape, with developments in regulation and the evolution of technology driving the move toward more patient-centricity. Here we look at some of the highlights.

A growing focus on innovation, diversity, and transparency has meant a year of positive development for clinical trials. At the start of 2023, we set out four trends we would be watching. We predicted that:

  • Decentralization of clinical trials would continue to grow
  • Technology would enable new approaches in clinical research
  • Clinical trials and their data would be more transparent
  • Sponsors would increasingly look for support

In this final blog post of the year, we revisit these trends and look and what has driven change in clinical research over the last 12 months.

New regulations and guidance

Enabling many of these developments has been the emergence of new regulations. Starting at the end of January 2023, the EU’s Clinical Trial Regulation came into force, mandating the use of the Clinical Trials Information System (CTIS) for new clinical trial applications in Europe. We looked back at the impact of the system in a blog post and shared our experience with it.

The US saw some changes in 2023 too: for example, starting in late 2022, the U.S. Food and Drug Administration (FDA) no longer required new medicines to be tested in animals for approval. The FDA also updated guidance for decentralized trials, inviting input from stakeholders including sponsors and investigators.

In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) aimed to streamline clinical trial approvals in the biggest overhaul of the country’s trial regulation in 20 years, “to make it faster and easier to gain approval and to run clinical trials in the UK.” The MHRA also announced a scheme that means “initial applications for the lowest-risk Phase 3 and 4 trials will be processed by the MHRA within 14 days instead of the statutory 30 days.”

Improving diversity and centralizing people

One example of regulation directly impacting the trends we followed this year is the FDA’s development of diversity guidance and requirements. Earlier in the year, Nature reported that, in “the biggest change in the regulatory landscape for clinical-trial diversity in the last three decades,” the FDA would soon require clinical trial applications to include a plan to ensure diversity of participants.

Diversity has been a major issue throughout 2023, with efforts like these in progress around the world to benefit clinical research, ultimately improving outcomes and therefore patients’ lives. It’s an important element of patient recruitment, which remains a challenge for clinical trials. And once a trial starts, many participants drop out, making retention equally challenging.

There is potential to improve recruitment and retention greatly. For example, in the UK, there has been a drop of 44% in enrollment over the past five years. Yet 68% of people would consider taking part in a clinical trial, despite 90% never having done so.

Digital technology is boosting research

As we wrote in a blog post this year, the latest applications of digital technology, like decentralization and AI, can help make a trial more efficient, effective and successful. But given the importance of patient centricity, it’s critical to ensure patients are consulted to understand their needs and preferences. This also means maintaining the human touch.

While decentralization was in the spotlight during the COVID-19 pandemic, artificial intelligence has been a major focus this year. The market for artificial intelligence (AI) in clinical research is projected to grow fast, rising to an estimated $3.89 billion by 2027.

AI has potential benefits for improving efficiency in the clinical supply chain, as well as in clinical research itself. This year we saw the first fully AI-developed drug enter clinical trials.

Continuing to seek transparency

Digital technologies and systems like the eTMF and CTIS can support the ongoing drive to improve transparency in clinical research. But gaps remain, and there have been calls for authorities to do more to improve transparency.

Following efforts from funders and the WHO publishing best practices, this BMJ article asked the question: is it enough? One study revealed almost one in five phase III cancer trials underwent changes to the primary endpoint after starting, and 70% of these went unreported. Researchers also warned that up to a quarter of trials in some areas might be faked or flawed.

But it’s much more common to see a lack of transparency due to negative results going unpublished. Participants expect all results of the trials they’re involved in to be shared, and in a blog post, we outlined all the other benefits of publishing negative results.

Sharing our tips and insights

Throughout the year, we have tapped into our experience and expertise at Siron Clinical to support those running clinical trials navigate this fast-changing landscape. On the Siron Clinical blog, we looked at the special requirements of various therapeutic areas, such as medical device and cardiovascular trials, as well as helping readers stay up-to-date and sharing our approach to working with clients. As we approach 2024, we look forward to another year of supporting clients across a range of trial types.

If you’re planning a clinical trial for 2024, get tips and insights from our blog, and contact Siron Clinical to find out how we can support you.

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