With the start of the new year, GlobalData released a new report providing a glimpse into what to expect in the clinical trial space in 2023. The report reviews clinical trials that are planned to start and complete this year.
GlobalData is the parent company of Clinical Trials Arena.
“This yearly report gives an early snapshot of what 2023 looks like,” says Brooke Wilson, associate director of research and analysis at GlobalData. The data includes planned clinical trials with a start date in 2023 and planned or ongoing trials with an end date in 2023, which were captured on GlobalData’s Clinical Trials Database as of 15 December 2022.
The trials that are set to start or complete this year were analysed and segmented by Phase, sponsor type, geography, therapy area, and indication. Also, this year’s annual report looks at the use of decentralised clinical trials (DCTs) for the first time. Clinical Trials Arena reviews some of the key highlights from the report.
Planned clinical trials in 2023
The report reveals that up to 43% of the planned trials this year are Phase II. Within Phase II, most of the trials have a planned start date in January. This is followed by Phase I (25%), Phase III (22%), and Phase IV (10%).
When it comes to single versus multinational trials, single-country trials are dominating 2023 with 89.8% compared to multinational trials with 10.2%. While non-industry sponsors account for the majority of single-country trials (63.1%), industry sponsors are leading the multinational trials (74.2%).
Such trends might be explained by the availability of resources. Wilson explains that non-industry sponsors, which are typically universities and institutions, may have limited funding to reach other countries to set up trials. Also, pharma companies tend to investigate new molecular entities, and they need to test in a wide array of geographical locations with genetic diversity.
Oncology as a therapy area and pain as an indication have the highest number of upcoming trials in 2023, and this is something that has not changed in the past few years, Wilson says. Covid-19 took over the clinical trial space in 2021, but even then the number of Covid-19 trials dramatically declined compared to 2020. In 2023, this indication is dropping to fourth place. Wilson explains this is likely due to approved vaccines and available therapeutics.
With DCTs rising in the past decade and accelerated by the Covid-19 pandemic, 6% of the planned trials have reported the use of one or more decentralised components. However, the report points out that this is not the final observation, and more information might be added as the trials progress. Clinical Trials Arena has previously reported on the DCT use per therapy area in H1 2022 and decentralisation archetypes per therapy area in the past decade.
Estimated completions in 2023
Similar to planned trials, most studies with completion dates in 2023 are in Phase II (46%), followed by Phase I (21%), Phase IV (18%) and Phase III (15%). The biggest proportion of these trials are currently ongoing and recruiting, while less than a third are yet to be initiated. Most of the trials in 2023 will be completed by non-industry sponsors.
Regionally, Asia-Pacific (APAC) has the highest number of trials with estimated end dates in 2023, followed by North America and Europe. Most of these trials are single-country studies.
However, the US as a country has the highest number of trials, followed by China and India. The report indicates that the top three countries were the same last year. After a five-year decline in trial activityand slow recovery after the pandemic, this year, the UK saw a glimmer of hope and has moved up in the rankings.
As for decentralisation, 5% of clinical trials with an estimated completion date in 2023 have at least one DCT component. While North America, Europe and APAC are leading the single-country trials with decentralisation elements, multinational DCTs are conducted more in the Middle East and Africa, as well as South and Central America. The latter trend might be explained by the low number of trials that are run in those regions. As a result, sponsors may incorporate neighbouring countries, Wilson notes.