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  1. Analysis
December 16, 2021

2022 forecast: diabetes, cardiovascular, respiratory trial activity set to rebound

Trial activity is on course to recuperate in hypertension, respiratory tract infections next year.

By Andrew Hillman and Reynald Castañeda

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  • The number of 2022 diabetes clinical trials is on track to surpass this year’s figures. This would mark the first year-on-year increase since activity fell because of Covid-19.
  • Trial activity in hypertension and respiratory tract infections is also on track to have the largest boost in 2022 in cardiovascular and respiratory disease categories, respectively. While the pandemic shifted resources away from non-Covid-19 respiratory infections, there is likely to be a resurgence in this space next year.
  • The pandemic has brought about two different narratives on trial activity. For example, pharyngitis may have lost trial activity momentum due to Covid-19 but is now making up for lost time. On the other hand, Zollinger-Ellison syndrome trials continued to experience increased activity despite lockdowns.

Diabetes, cardiovascular, and respiratory diseases are among research areas that are likely to have the most gains in global clinical trial activity in 2022. These estimates are based on publicly announced planned trials, as well as projections based on historical data available on the GlobalData database.

In cardiovascular disease, hypertension is anticipated to have the largest increase in activity. While there has been a drop in non-Covid-19 trials among respiratory tract infections during the pandemic, there will likely be a resurgence in this space next year.

Anticipating trial activity levels in future years is challenging. Most clinical trials are made public in the same year that they are set to begin, and sponsors often only announce a trial start date shortly before the study initiates.

For our forecast, we began by listing trials announced to start in 2022. We then looked at planned trials without a start date and analysed past data to estimate how many of these trials would begin next year. Finally, historical data was used to project the number of yet-to-be-announced 2022 trials, which will be publicised and initiated within the next year.

Diabetes on trend for 2022 clinical trials

In diabetes, GlobalData has identified around 80 clinical trials due to begin in 2022. In addition, there are about 300 planned trials with no announced start date. Based on an analysis of how long past trials have taken to advance from announcement to initiation, we anticipate that approximately 230 of these 300 trials will begin in 2022.

And so, in total, we project that around 310 announced diabetes trials will start in 2022. In comparison, at the same time last year, there were only 180 announced trials for 2021. Consequently, the number of new diabetes trials to start next year are on course to surpass this year’s levels, which would mark the first year-on-year increase since trial activity fell during the pandemic.

Meanwhile, in hypertension, initial 2022 figures also suggest that new trial activity could far exceed that of 2021. There are about 220 announced trials projected to begin next year, which is just over 50% of the total trial numbers for 2021. For context, only 20% of 2021 trials had been identified by GlobalData at the beginning of the year. In other words, 2022 hypertension trials are far ahead of the 2021 count at this same point last year.

University Milano-Bicocca professor of medicine Giuseppe Mancia was “surprised” to hear of the potential increase in hypertension clinical trial activity over the next few years. There have been no major hypertension trials since the Systolic Blood Pressure Intervention Trial (SPRINT), Mancia says. There are few plans to address therapeutic gaps for different types of hypertension, such as masked, white coat and resistant hypertension, he adds. And with the pandemic, it may create insurmountable problems to conduct randomised trials, he notes.

Looking into the data, the anticipated increase in hypertension trials is primarily driven by increased activity in China, India, and Russia, where six out of every ten planned hypertension trials are situated.

Respiratory infections tracking positively

As for respiratory tract infections, it should not be surprising that the number of such trials outside of Covid-19 dropped during the pandemic, with resources directed towards SARS-CoV-2 infection studies. But 2021 paints a different story: new non-Covid-19 trial numbers remained sluggish, despite there also being a dramatic drop in Covid-19 trials. In fact, 2021 only saw around 55 new Covid-19 trials, which is a big decline from an estimated 300 studies in 2020.

Our analysis suggests that 2022 could see a resurgence in the non-Covid-19 space. GlobalData has already identified around 110 respiratory tract infection trials likely to begin in 2022, of which only seven relate to Covid-19.

As for other respiratory diseases, bronchitis, pharyngitis, and allergic rhinitis are also set to exceed 2021 levels of new clinical trial activity. In bronchitis, new trial activity next year is on course to more than double compared to 2021. This year, there were only around 70 new bronchitis trials, while there are already 130 planned bronchitis trials yet to begin. While these trials are yet to have a start date, previous trends indicate that around 80%, which is approximately 100 trials, will likely start next year.

Varied trial activity during the pandemic

In 2022, many prepandemic clinical trial activity trends will likely kick back into gear. Clinical research organisations and sponsors continue to find ways to stage trials within a pandemic setting, such as the use of decentralised and/or virtual trial components. On 14 December, Clinical Trials Arena reported that decentralised clinical trial design uptake is on course to reach new heights in 2022, with a 28% increase compared with 2021. Also, trials whose start dates have been delayed by the pandemic are finally getting under way.

As an example, the number of new pharyngitis trials had been rocketing up in the years before the pandemic, but activity stalled with a 25% drop due to Covid-19. Now however, pharyngitis trials are set for a resurgence. There are currently around 75 planned pharyngitis trials without a trial start date and, if most of these studies begin in 2022, then activity will be on track to surpass 2019 levels. Other indications on trend to bounce back after a fall in clinical trial activity during the pandemic include skin and soft tissue infections, urinary bladder inflammation, urinary tract infections, and hyperparathyroidism.

On the other hand, certain disease areas continued to see rising activity despite Covid-19. One example is the rare digestive disorder Zollinger-Ellison syndrome. Between 2010 and 2016, an average of seven new trials were initiated each year. Activity has since shot up: there were almost 60 initiated trials over the past two years. With almost 50 planned trials, growth in Zollinger-Ellison syndrome trial activity is likely to continue in 2022.

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