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Top 7 trends in Imaging Clinical Trials in 2023

The imaging clinical trials industry is growing at a fast pace. To help you keep up, we have investigated the top trends to look for in 2023!

Integration of Wearables

Wearable technology has the potential to significantly impact clinical trials by providing continuous, real-time data on participants' health and behavior. This can provide a more comprehensive and accurate picture of the effectiveness of a treatment being tested. Wearables can also reduce the burden on participants by allowing them to self- or even automatically report data. The market for wearable brain devices such as Brain Scientific’s NeuroCap alone is forecasted to grow 12.33% year on year to USD 668.5 million between 2022 and 2030. However, there are challenges to the integration of wearables into clinical trials, such as ensuring data accuracy by proper usage and addressing privacy and data security concerns. Overall, the integration of wearables into clinical trials has the potential to revolutionize research and lead to the development of more effective treatments.

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Digitalization

The COVID-19 pandemic called for the clinical research industry to adapt and innovate. Much of this innovation took place digitally, whether for organizational purposes, remote patient monitoring or digitally-enabled analytics. Investment in the digital realm remains a top priority for biopharma companies who are laying the foundations for even more advanced technologies to break into the imaging trials market, such as quantum sensors.

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Decentralized Trials

Decentralized clinical trials (DCTs) are a new approach to conducting clinical research that allows participants to receive treatment and provide data remotely, rather than having to visit a central study site. This can be especially beneficial for trials that involve large, dispersed populations or for individuals who may have difficulty traveling to a study site due to geographic, financial, or other barriers. Another brainchild of the pandemic, DCTs are made possible by advances in technology such as telemedicine, electronic data capture, and wearable devices, which allow for remote monitoring and data collection.

One key advantage of DCTs is that they have the potential to increase access to clinical trials for a wider range of people, including those who live in rural or underserved areas. DCTs can also reduce costs for sponsors and research sites, as they eliminate the need for physical visits to study sites and can potentially reduce the number of participants needed for a trial. Bayer’s 2021 proof-of-concept DeTAP study showed that DCTs could be effective at recruiting and retaining patients. However, there are also challenges to conducting DCTs, such as ensuring data quality and security, and finding ways to effectively engage and support remote participants. Despite these challenges, DCTs have the potential to significantly impact the way that clinical trials are conducted and could fasttrack the development of more effective treatments for a wide range of conditions.


Optimizing the patient experience

2023 should be the year for less talk, more action when it comes to prioritizing patient experiences during a trial. The first three trends on our list are all designed with this in mind. Imaging isn’t always the most accessible or indeed appealing endpoint, but Medpace estimates that in 2022 50% of clinical trials needed imaging data. May et al.’s 2020 questionnaire identified the use of ionizing radiation, number of scans (> 3) or scan duration (> 60 mins), time off work, and cost and time of travel as some of the most consistent barriers to participation in a trial. Some of this reluctance may be simple to counteract: as many as 50% of new recruits deem discussion with research staff regarding the study and imaging regimen to be a key factor in a positive trial experience. Trial organizers should work to close the gap between themselves and the patient should they wish to keep participant numbers, and therefore study power, high.

Further reading:

  • May, K., Lee, M., Jefford, M. et al. Imaging in clinical trials: a patient-led questionnaire study to assess impact of imaging regimes on patient participation. Res Involv Engagem 6, 15 (2020). https://doi.org/10.1186/s40900-020-00195-5


Psychedelics

The 50-year hiatus from clinical research into psychedelic compounds came to an end in 2006 when a landmark John Hopkins University study revived a long-lost confidence in the safety and therapeutic potential of psilocybin and psychedelics more generally. Initial reports of their benefits in alcohol abuse, cancer-related anxiety and depression have now evolved into a series of early phase clinical trials focussing on anorexia nervosa, chronic pain and other mental health disorders. These efforts are greatly sponsored by academic institutions, though there is increasing interest more recently from private organizations such as Clerkenwell Health who are looking to commercialize and ease the pain of the development of psychedelic drugs, many of which are labeled ‘controlled substances’. 

Imaging is set to play a pivotal role in this development process. In the study of compounds where subjective patient experiences are obvious and make blinding trials a near impossibility, objective biomarkers are crucial. fMRI studies of the brain under the influence of psychedelics reveal the disruption of large-scale functional networks. Changes are also observed in cerebral blood flow to the amygdala and anterior cingulate neurotransmitter levels. PET imaging with 5-HT2A agonist radioligands could help to elucidate long-term drug action at a molecular level, although such ligands are currently lacking. 2023 will see the accelerated pursuit of reliable imaging biomarkers for use in psychedelic clinical trials to ultimately get to the bottom of these ‘hope or hype’ treatments.

Further reading


Multi-modal imaging

Imaging in clinical trials was initially limited to camera-based techniques in dermatology, but its use has since expanded greatly: from ophthalmic and ultrasound techniques to advanced molecular and cross-sectional modalities such as MRI. Each has their respective advantages, but also limitations. Multi-modal imaging is therefore crucial and looks not to be the exception, but rather the rule as we look towards the future of imaging clinical trials. Richer datasets will help to better disambiguate the signal from the noise. Combined with further information such as that from genome-wide association studies, trials can also take a step towards a more selective patient recruitment approach based on endophenotyping.


End-to-end imaging solutions

As each of these trends improve trial accessibility, increase data volume and complicate data security, 2023 and beyond will see an increasing reliance on end-to-end solution providers to tie it all together. Trial sponsors will seek to cut costs by handing over the imaging arm to third parties such as QMENTA. This has the potential to ensure optimal site coordination, data harmonization and secure and efficient image analysis, all with the objective to extract as much as possible of the rich information that imaging data has to offer.

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