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COVID-19


Figure 2: Biological versus non-biological drugs as a percentage of the pipeline, 1995–2019 Non-biotech


Biotech


100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%


part – the plunger rod that does not contact the drug – for a connected device. Synnect also provides advanced technological features in comparison with other connected devices; by using BLE to transmit injection data – time and volume – via a smart device app to a secure cloud, Synnect accurately and continuously measures the injected volume. This feature allows Synnect to report a partial dosing, rather than just reporting end of injection, which is the common option for the majority of connected drug-delivery devices. The cloud-available data supports enhanced control over the study by the monitoring staff. In addition, Synnect offers valuable features, such as providing administration alerts and reminders, as well as instructions for use.


Positive effects for clinical trials When it comes to clinical trials of injectable drugs, the route for enhanced patients’ convenience does not stop at connected drug-delivery devices, as clinic visits are not the only cause for inconvenience. Many patients suffer from needle phobia, perceiving the pain of injection harder than it actually is. Needle phobia is present in over 20% of adult patients, and its rate in children


90 | Outsourcing in Clinical Trials Handbook


and adolescents is even higher. Therefore, many patients might feel inconvenienced to participate in a clinical trial of an injectable drug. For this reason, user-friendly injection devices should be used as part of clinical trials – DALI’s SAN product line of safe-automatic needles is easy to use and compatible with a variety of primary containers, hides the needle throughout the entire injection process and helps overcome needle phobia. The combination of a connected drug-delivery device with a user-friendly injection device provides a superior user-experience, enabling care at home with maximum comfort. Improved patient convenience would reduce the clinical trials dropout rate, helping pharma companies shorten the time-to-market and minimise costs. As the entire world is currently facing the


Covid-19 pandemic, the significance of remote care is emphasised, in addition to the patients’ convenience; home care is also useful for protecting patients at risk, by enabling them to get their medication treatment at home instead of at the clinic. Digital health, in the form of connected drug-delivery devices, enables improvement clinical trials’ effectiveness, while protecting patients’ health simultaneously. ●


Percentage


1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019


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