Optimising waste in today’s clinical landscape
The complexity of clinical trials is constantly growing, causing increased amounts of waste. With around 20% of waste resulting from ineffective supply schemes, Oximio is focusing on waste mitigation as a key component in the delivery of a robust clinical supply chain.
Underpinned by disruptive drug manufacturing technologies, new trial designs, technologies and the so-called ‘data revolution’, the clinical trial landscape is changing. As clinical trials become more complex, waste levels are increasing. It is reported that as much as 20% of clinical trial drugs are wasted in complex clinical trial designs due to inefficient supply schemes. A lack of ability to reach patients on time, coupled with failure to meet patient recruitment, and retention targets is resulting in insufficient drug efficacy and safety data, and prolonged clinical trials. In some cases, this has led to failure to receive market authorisation.
Expanded access
To tackle these challenges, sponsors need to diversify. One way of achieving this is through implementing an expanded access programme. These programmes provide investigational drugs to seriously sick patients who have exhausted all other viable treatment options. However, regulations and measures relating to each programme tend to differ from country to country. It is therefore important that one has a thorough understanding of each country’s regulations and assess any advanced supply capabilities.
Patient-centred attraction and retention
Patients may either be unwilling or unable to travel to clinical sites. Many prefer to receive drugs in the comfort of their home. However, while demand for Direct-to-Patient (DtP) home deliveries is growing, this type of scheme is still not properly regulated in many countries. Its successful implementation requires high expertise in trial protocol planning with an ability to draw on a robust supply chain focused on waste optimisation.
Oximio offers risk-free deliveries to patients’ homes and arranges in-home clinical visits for clients. Through this service, Oximio is working to enable greater patient retention on clinical trials, while helping to optimise clients’ waste reduction strategies.
Optimising comparator sourcing
Oximio has streamlined its approach to comparator sourcing to deliver significant waste-saving gains. Making sure that inventory levels are optimised with the correct quantity for a trial’s needs, the exact pack size requested needs to be supplied to avoid any possible wastage. The longest expiry date is sourced to cover the trial’s duration, as well as any delays or trials being put on hold. For larger quantities, it is also good practice to source the product direct from the manufacturer where possible, requesting a new batch release to obtain the longest product expiry. Products must be shipped and stored at the correct temperature and validated at every stage of the supply chain. This is essential for making sure no products are wasted due to temperature excursions. Also, if agreed within the terms of the project, any unused drugs can be sent back to the supplier, to further minimise drug wastage.
Oximio has over 19 years’ experience in the end-to-end optimisation of robust, tailor-made clinical supply chains and creation of patient-centric services. Working in partnership with its clients, Oximio navigates complex, multi[1]regulatory environments and plays an important role in supporting the fulfilment of investigational products, while ensuring the optimisation of clients’ waste strategies.
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For further information on how we can support you with your clinical trial logistics requirements, please contact us.