With new regulations and guidance promoting transparency, growing calls for better representation, and accelerated developments in technology, the clinical trials landscape is changing continuously. Here is a round-up of the big trends of 2023 so far.
At the end of 2022, we shared our predictions of the big trends we expected to see unfold in 2023, focusing on decentralization, technology, and transparency. Now, halfway through the year, these topics are making headlines around the world, and people are at the heart of the discussions.
Participant recruitment and diversity
This year’s Clinical Trials Day (17 May) was about patients and the importance of involving them in every step of the clinical trial process, from design to publication.
Recruitment can be one of the most challenging aspects of running a clinical trial, yet there is great potential to bring the right people into trials, with the “untapped potential” in the UK being a particular talking point. According to a recent survey, although 9 out of 10 people in the UK have never taken part in a clinical trial, 68% said they would consider it. Yet the Guardian reports has been a 44% drop in enrollment over the last five years. The UK government is planning to quadruple the participants in commercial clinical trials in the course of the next four years, potentially including using incentives.
This has implications for increasing diversity and representation in clinical trials too. Despite a focus on diversity and some improvements, a recent study by Clario and Tufts Center for the Study of Drug Development (CSDD) involving 1,165 clinical trials shows “wide disparities, based on disease prevalence, particularly for patients who identify as black and ‘other’ races.” And a multi-site observational cohort study by the Mayo Clinic involving 12,000 patients from 58 cancer clinical trials revealed that two underserved groups – persons of Hispanic ethnicity and older patients – were more likely to withdraw from their trials.
Decentralization and its role in recruitment and retention
The trend towards greater decentralization that gained ground during the COVID-19 pandemic is continuing globally. The FDA has released draft non-binding recommendations for implementing decentralized clinical trials for drugs, biological products, and devices aimed at sponsors, investigators, and other stakeholders. The FDA held a webinar on the topic and is inviting comments on this draft guidance until 1 August 2023.
Research is uncovering the benefits and potential limitations of this increasingly popular approach. While the increase in decentralization holds promise for improving diversity, it’s not a simple cause-and-effect situation, and there are calls to evaluate the impact it is having, including in comparison to traditional in-person trials.
Technology can support recruitment and more
Technology could be key to improving diversity and recruitment more generally. A bill signed into law in Washington in May sets out requirements to remove barriers to joining a trial, including making electronic consent available.
As artificial intelligence (AI) grows in popularity and utility across industries, it is also making inroads in clinical research. For example, AI is already connecting patients to clinical trials through matching platforms. And beyond recruitment, it is promising for improving efficiency in the clinical supply chain – an important consideration for any trial.
Analytical approaches are helping design complex trials too. In this paper in Nature Scientific Reports, researchers use geometry to solve a challenge in personalized oncology clinical trials: how to manage multiple therapies, biomarkers, and cancer types for a sensitive population. The result is a hypersurface – a complex geometric shape that visualizes a master protocol.
Half a year into the Clinical Trials Information (CTIS) for European clinical trials, there are more than 320 recorded in the system. But research continues to highlight gaps in transparency.
There are many initiatives ongoing around the world to address this, including a push from patient and research groups in the UK for the government to take action. The joint letter said: “There is unanimous consensus among experts that failures to register and report the outcomes of clinical trials distort the medical evidence base, impede scientific progress, harm patients, and undermine public health.”
Similarly, in the US, the National Institutes of Health (NIH) is toughening enforcement of delayed clinical trials reporting and has taken action on more than 200 cases since July 2022.
When results are reported, they’re not always as transparent and usable as they could be. New guidelines published in JAMA Special Communication aim to address this.