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CLINICAL TRIALS IN 2022: WHAT YOU NEED TO KNOW

 

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Decentralisation, unconventional trial designs, and operational challenges
raised by the pandemic will be prominent themes this year.

 

By Reynald Castañeda

 

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Against the backdrop of the Covid-19 pandemic, clinical trials in 2022 will
likely further embrace the mechanisms it had to speedily adopt in the past 22
months.

Specifically, decentralised clinical trials will continue to be a hot topic, and
trial sponsors will consider unconventional trial designs to ensure studies
succeed in an unpredictable healthcare landscape. Certainly, the quick
turnaround in getting Covid-19 therapeutics and vaccines from laboratory to
market will further inspire sponsors to get their respective assets through
trial development at warp speed pace.




FORECASTING 2022

An exclusive Clinical Trials Arena investigation shows the frequency of
decentralised clinical trials will reach new heights in 2022, with a likely 28%
jump from last year. This analysis by Andrew Hillman and Kezia Parkins looks at
the specific decentralised elements that will gain significant momentum this
year. On that note, Darcy Jimenez looks at some tech innovations set to
impact drug discovery and development in 2022.

In another exclusive data-led investigation, Andrew and Reynald Castañeda
investigate which diseases are set to have an increase in clinical trial
activity this year. In a separate article, Manasi Vaidya discovers that, fuelled
by the successful use of mRNA vaccines in Covid-19, RNA therapeutics
are expected to make larger strides in 2022.

Based on available data, there are emerging trends as to what the clinical
trials operations industry is investing in this year, according to a report by
Patrick Scott. With many clinical trial sites based in hospitals, Azadeh
Laffafian, in a comment piece, looked into which countries are likely to have
the most hospital project completions in 2022. As for the environmental, social
and governance (ESG) framework, Jennifer Smith-Parker reports that sponsors see
artificial intelligence as its main investment target, with 3D printing being an
untapped area.


OPPORTUNITIES RAISED BY THE PANDEMIC

The Covid-19 pandemic has further revealed parts of the healthcare system that
need improvement. As an example, Darcy and Andrew crunched the numbers to find
out what drugs are in short supply in the US, based on FDA data.

Unconventional trial designs have been increasingly considered over the past
several years to enhance efficiencies in clinical trial operations. In a series
of investigations, William Newton discovers that there could be an opportunity
for platform trials to gain momentum in rare dystrophies or gene therapies.
While data shows that basket trials have more traction than umbrella trials,
both are still a drop in the bucket in the cumulative rare disease studies.

The Covid-19 pandemic has further emphasised the need for better representation
in clinical trials. In fact, this was a hot topic at last month’s Annual Meeting
of the American Society of Hematology (ASH).

Hematological cancer investigators told Adam Zamecnik the ways in which the
industry could be more inclusive, with their comments applicable to a wider
range of indications.


PHARMA: THE BIG PICTURE

Elsewhere in pharma, Darcy looked into which products fall in the grey area
between drugs and devices, and what financial and regulatory consequences are
there for companies that wrongly classify their assets. Meanwhile, Fiona Barry
and Manasi find that a recent international agreement to harmonise tax
rates evoked mixed views on its real-world impact for pharma companies
headquartered in jurisdictions long considered tax havens.

Looking at the bigger picture, Andrew reports that middle-income countries’
healthcare sectors are expected to outgrow those in high-income countries up
until 2024. And with the more transmissible Omicron increasingly becoming the
most prominent SARS-CoV-2 variant, Azadeh questions in a comment piece if this
will extinguish the spark of recovery seen in the hospital sector that was
detected last year. Also, she asks: how real is this 2021 recovery and will this
momentum continue in 2022?

In our disease-specific coverage, Kezia investigates the future of
hypogonadism treatments. Also, Darcy reports on the threat of antibiotic
resistance and its impact in treating chronic urinary tract infections.

 

 

 

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