Evolving Clinical Trial Landscape
Where are clinical sponsors focusing their efforts?
In 2021 there were a total of 413,028 registered studies globally.
Breaking this down (and according to our study) in 2022 Life Sciences organisations intend to focus (or indeed are already focusing) their clinical studies on:
In which of the following areas are your clinical studies focused this year?
The number of clinical trials focused on novel and next-generation therapeutics, such as cell and gene therapies, continues to increase – from 23% in 2021 to 36% in 2022. Many of these trials focus on rare diseases where no effective treatments exist. They potentially offer patients the prospect of meaningful clinical improvements, even cures, after a single dose.
'85% of Life Sciences organisations say they plan to optimise the conduct of clinical trials over the next 12 months.'
Optimising the conduct of clinical trials
Following on from the previous section, 85% of Life Sciences organisations say they plan to optimise the conduct of clinical trials over the next 12 months.
This ties in closely with their efforts to streamline processes, reduce cost and increase efficiency within trials.
When asked specifically about where they plan to prioritise their efforts, our respondents highlighted a broad spread. There was little to separate the top five priorities as shown in the chart, which perhaps highlights uncertainty about where best to start or focus efforts.
Over the course of 2020, the industry pivoted towards digital technology in a bid to overcome disruption to clinical trials and maintain patients on treatment.
The data in this 2022 Arkivum survey suggests that many have now adopted remote monitoring strategies, so disruption is no longer such a threat.
In 2021, 47% of respondents said they would prioritise increasing remote treatment; this compares to 33% in 2022; in 2021, 38% said it was a challenge to run a study remotely, while the figure for 2022 is 30%.
You can access the full chart here.
As organisations look to optimise conduct of clinical trials, which of the following will be a priority for your organisation over the next 12 months?
Challenges faced in running a clinical trial
The vast majority of Life Sciences organisations (86%) continue to face challenges when running a clinical trial. You can see some of the main challenges they face in the chart here.
Interestingly, but maybe not unsurprisingly, there has been an increase (to 34% from 19% in 2021) in the proportion of respondents experiencing difficulties in managing data from multiple CROs. As more organisations adopt a range of different technologies, it can become harder to achieve interoperability. It is a challenge that we at Arkivum regularly see our customers face.
Unless this is addressed by CROs and sponsors (perhaps with the help of organisations such as CDISC and the TMF reference model) this will likely only become worse.
Collaboration across sites with other study partners also ranked high as a challenge. It was identified by 26% of respondents, down slightly from 2021 (30%).
Fewer organisations report challenges in running a study remotely –30% vs 38% in 2022. While it remains one of the top three challenges, this decrease demonstrates progress as life sciences organisations grow accustomed to running remote trials.
Finally, a higher proportion of organisations (20% vs 14% in 2021) reported challenges in maintaining quality, regulatory and compliance standards with the aim of ensuring inspection-readiness. This development was also reflected in an acknowledgement of the general challenge of keeping abreast of changing regulations, as detailed at the beginning of the report.
In all likelihood, this will continue to prove a challenging area as regulators aim to keep pace with the changing approach to the management of clinical trials in a post-pandemic world. This can encompass everything from new data retention requirements to the regulation of wearable devices.
Challenges running clinical trials - 2021 vs. 2022
Managing data from multiple CROs
Running a study remotely
Keeping up with quality regulations
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