Clinical supplies & logistics
use this rationale, it means that the huge variety in trial specifications breeds a huge variety in clinical supply chain pathways. “A single-treatment, single- site study, will have fundamentally different supply chains compared to a global, double-blind, phase 3 study,” adds Williamson.
Tweaking the template There’s a good reason to optimise the supply chain strategy in a clinical trial. According to McKinsey, best-in-class standards can result in better investigator and patient experiences, a reduction of up to two years in the time it takes to launch a new drug and potential cost savings of between 15% and 20%. Of course, the opinions of supply chain professionals are going to differ on what constitutes ‘best-in-class’, but whether it’s a single- site study or a decentralised one, there are common factors that have a big impact on how well a clinical supply chain performs.
“At a general level, almost all points of patient interaction will have an impact on the clinical supply chain,” explains Williamson. “This could just be the location of that patient, dictating the need for a regional depot, or it could be the actual products given to the patient, meaning multiple sourcing and packaging activities are needed.” Packaging can add another level of complexity if the study is blind, bringing the requirement for bulk purchase and multi-language relabelling, adds Williamson.
Another important factor to consider is the sourcing of co-therapies and comparators. As well as the candidate drug, other products used in studies bring some of the largest complexities for clinical supply chains. For example, these products might not be approved in certain countries, limiting the options for certain regions and adding an extra variable to consider during the analysis phase of the study. “Then there is patient administration,” adds Williamson. “The specific product requirements and usage greatly impact the clinical supply chain. Looking at the product, material that can be stored at ambient temperatures will have a much simpler pharmacy supply chain, compared to biological products stored at -80°C.” It’s not just how a product is stored, but also how it’s administered that can add another layer of complexity to a trial, adds Williamson. For example, a product administered intravenously must be given in the clinical setting, whereas a tablet the patient can take at home will come with its own complexities around reconciliation and patient tracking.
The buck stops with the sponsor For multi-site studies, Williamson says the countries in which the trial is recruiting patients
Clinical Trials Insight /
www.worldpharmaceuticals.net
will shape the overall clinical supply chain strategy. “For one, the complexity of a clinical supply chain across Africa is far greater than Europe,” he says. “In Europe, for example, shipping products across the EU is made relatively simple, unlike cross- border shipping in other parts of the world. In addition, the more countries involved in a trial, the higher the likelihood of logistical constraints or ancillary stock-outs.” Despite the many challenges, the template set down by regulators will define many of the parameters needed to conduct a successful trial. In many cases, regulations define the key ingredients around which the specific requirements of a trial’s supply chain can be built.
Labelling can add complexity to the clinical supply chain if a study is blind or double-blind.
“Looking at the product, material that can be stored at ambient temperatures will have a much simpler pharmacy supply chain, compared to biological products stored at -80°C.”
“Clinical trials are tightly regulated and there are clear minimum expectations of what a sponsor should have in place and documented,” says Williamson. “Based on the regulatory requirements and good practices, I believe the principles that are crucial across all types of studies include the clinical trial sponsor being accountable for the entire clinical supply chain, even where outsourcing of activities occurs.”
The clinical supply chain starts at material manufacture and continues all the way to patient administration, with the final step being reconciliation. “The sponsor should hold a Quality Management System (QMS) which allows for full oversight over the clinical supply chain. And full traceability of any clinical trial material should be
6,100
More than this number of industry- funded interventional clinical trials were launched in 2019.
Clinicaltrials.gov 23
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Shutterstock.com
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