In meeting the growth ahead for clinical trials there must be a focus on efficiency as their supply already suffers from major issues with wastage levels. This is lack of control is problematic with the rising public scrutiny on spending by pharmaceutical companies.
The drive to address the diseases that strike the world’s aging population has increased Pharma’s R&D funding. This trend is set to remain, industry estimates state that after seeing lucrative growth in 2016 the clinical trial market size is set to balloon to $65.5 billion in the next eight years.
The supply of these trials is critical. Badly budgeted or scheduled clinical trials can jeopardize the progress made by a candidate.
Clinical trials are incorporating a larger amount of countries than ever before. Although this is positive for producing more representative data and developing products for emerging regions, this globalization does introduce logistical hurdles in terms of supply. Especially with country specific regulations constantly evolving.
Rapid growth seen in emerging markets incurs more supply challenges. Sponsors are expected to provide to trial sites in isolated regions that have limited infrastructure and stubborn climates.
Clinical trials require the production and distribution of investigational pharmaceuticals to thousands of participants over several years.
Sponsors and Clinical Research Organizations (CROs) need to ensure they don’t over supply sites. This excess leads to the wastage of expensive materials, as drugs reach expiry dates before they can be used.
When sites are under supplied, sponsors may have to halt enrolment or even freeze patient treatments. This could have a large influence on the outcomes of a trial. Due to a range of factors, study design, patient enrolment, quantity of sites, site location, that can suddenly change the level of supplies needed for a trial to run, supply managers reduce the risk of stock outs by supplying a surplus of medicine. This in many cases spills over to become overage – when the investigational medicines have to be wasted at the end of a trial or hit their expiry dates before consumption.
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