Rethinking clinical trials in a COVID-19 era

In total, a vaccine can take more than 10 years to fully develop and costs up to $500 million. While in contrast, Pfizer and BioNTech’s COVID-19 vaccine was developed and approved in a matter of months.

Interesting stat – Did you know repeat volunteers, known as professional lab rats or “human guinea pigs” (a term coined by George Bernard Shaw), can make upwards of R800 000 annually [source: WingMcHugh].

Having enjoyed steady growth over the last several years, it’s predicted that the global clinical trials market will hit a value of $69.9 billion by 2027.  Dov Paluch, Managing Director at Catalyst Solutions, says this number could potentially even be higher in the face of new pandemic threats as well as reports of Coronavirus mutations.

“This illustrates the sheer speed with which pharmaceutical companies have had to work in the race to find a vaccine for the virus. Pharmaceutical companies have been pushed to create new ways of working, accelerating digital adoption, and innovation across their organizations within weeks—far faster than almost anyone could have imagined.”

How clinical trials work

This month, the UK became the first Western country to approve a vaccine, marking a pivotal moment in the global fight against coronavirus.

From a South African perspective, the country is hosting three trials, including for Johnson & Johnson, Novavax, and a partnership between AstraZeneca Plc and the University of Oxford.

There are several stages to vaccine development, such as the exploratory, pre-clinical, clinical, review and approval, manufacturing and quality control stages. A key step in the process of any vaccine development is clinical testing, which involves assigning a vaccine or a placebo to human subjects, then evaluating the health effects over a period of time. There are three phases where humans participate in the trials:

Phase I – Phase 1 testing marks the first time the vaccine is tested in a small group of adults, usually between 20 to 80 people, to evaluate its safety and measure the immune response it generates. Usually, you look at several different vaccine candidates and ultimately choose the one that has the best immune response and evidence of protection. This stage of preclinical work generally lasts one to two years.

Phase 2 – A larger group with different characteristics (such as age and health status) are given the vaccine to further test for safety, effects, and dosage. Phase 2 studies aim to determine the most effective dose and expand the safety experience with the vaccine. Researchers look for expected reactions to the vaccine—which could include anticipated adverse events, like headache, muscle pain, redness and swelling at the injection site or low-grade fevers—as well as serious adverse events, which are expected to be rare, over the entire duration of the study.

Phase 3 – During this stage of the clinical trial, even more volunteers receive the vaccine to study whether it’s effective. It may be that some people do go on to develop COVID-19, even after having been vaccinated, but they may have substantially milder symptoms than those who develop COVID-19 in a control group. Phase 3 trials can sometimes take years and include up to 60,000 people.

A shot in the arm for R&D

COVID-19 has impacted almost every aspect of society and the scientific R&D industry is no exception.  Dov says the medical research ecosystem has been forced into overdrive in response to the virus, spurring unprecedented speed and agility.

There’s no question that the pandemic has forced the pharmaceutical industry to rethink clinical trials, simultaneously creating significant disruption, as well as spurring innovation at a lightning pace.

“While in many respects, the COVID-19 pandemic has reflected a failure of the global health system, it has also revealed the extraordinary resilience of this ecosystem, highlighting the importance of R&D and innovation in guiding us through the pandemic.”

Dov says R&D has proven instrumental in fuelling the innovation engine that is helping the pharmaceutical industry address this and other crises. The virus has also spurred collaboration and the integration of digital solutions in clinical trials. There has also been an increase in virtual trials, which use remote monitoring, teleconferencing, and digital data collection tools to conduct trials outside of traditional clinical trial sites.

“ Prior to the pandemic, the pharmaceutical industry had generally been slow to digitize its clinical development processes. In the post-pandemic landscape, we anticipate R&D and technology to take centrestage in the pharma space as the sector is presented with new and previously unseen challenges.”

South Africa’s Section 11D Tax Incentive includes a specific section that was added to deal with the inclusion of clinical trials as qualifying R&D activities for the incentive. For more information on this, get in touch with a member of the Catalyst Team.

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