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The importance of Phase III trials

November 30, 2020

As public interest in the race to find an effective vaccine for Coronavirus grows, so too has the widespread desire to learn more about pharma research, clinical trials and manufacturing development.

With numerous vaccines progressing through the first and second stages of testing, many are now teetering on the edge of mass manufacture and distribution. However, before this happens, it is essential that they successfully negotiate the final hurdle and pass Phase III trials.

This key safety requirement for patients and manufacturers ensures the final product is as safe as it is effective. Originating in the 1940s, Phase III trials are firmly connected to early RCTs carried out in the UK in the treatment of tuberculosis.

Following the issues surrounding thalidomide in the late 1950s and early 60s, Phase III testing became essential when the US FDA led the way (with all other major regulators following) in demanding all new medicines undergo thorough clinical testing before entering the market.

Phase III is not a simple box-ticking exercise. It is rigorous and involves a minimum of 100 patients, sometimes rising to 1000s of individuals to ensure an accurate insight of how the treatment could perform on a broader scale and over a much longer period of time, occasionally lasting for years.

In addition to this, it can be incredibly expensive. The US industry group, the Pharmaceutical Research and Manufacturers of America estimated the cost of Phase III trials at $42,000 per patient in 2013, rising to nearly $90,000 per patient for the most complex trials.

This cost can be further compounded by the fact that investment does not always guarantee success – data from Harvard Medical School revealed 54 per cent of Phase III trials between 1998 and 2008 failed.

However, despite their cost and time considerations, Phase III trials remain essential. However, as highlighted by the pandemic impact, there is a real need to expedite them and improve flexibility into the testing and approvals process.

The encouraging news is that this has already started and is gathering pace.

The FDA’s Fast Track, Breakthrough Therapy and Priority Review, the Accelerated Access Review in the UK, and the European Medicines Agency’s PRIME and Accelerated Assessment are all steps in the right direction in the drive to accelerate pharma research, design and manufacture.

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