COVID-19
injectable drug is tested. Consequently, particular effort should be made to improve patient comfort during clinical trials in injectable drugs. Specific solutions should be tailored to the clinical trials’ market segment. We know now that such solutions could not rely on the patient, as the approach of promoting patients’ change is not effective due to patient-related barriers and the solution should be based on other means. One of the most efficient ways to enhance patient comfort is to let the patients administer the drugs at home. This would help reduce the dropout rate by omitting the need for frequent clinic appointments and easing the burden on patients. On top of this, studies that will be conducted in the home environment are more likely to be easier for patient recruitment in the first place. During the pandemic era, this need becomes even more obvious.
The solution – connected drug-delivery for injectable drugs Internet of medical things (IoMT) means converging digital technologies, including sensing and connectivity, into healthcare products. Combining IoT technology with injectable drug-delivery yields connected drug- delivery devices. Such devices enable accurate monitoring on drug administration and could promote injectable drug administration at home. Incorporating connectivity devices, as part of the clinical trials for injectable drugs, would allow the patients to take the medication at home, instead of at the clinic. Eliminating the requirement for multiple clinic visits would enhance patient convenience, aiming to reduce the dropout rate. Connected drug-delivery devices also provide accurate data on a patient’s drug administration. Such data, readily available to the CRO staff, would allow them to take proactive action when a patient does not adhere to the prescribed treatment, preventing such patients from being excluded from the trial. This would push the dropout rate down even further. It seems that connected devices are the
ultimate solution for injectable drugs’ clinical trials. Why aren’t they more abundant if so? Why aren’t they more commonly used? The answer to this question lies in the existing selection of connected drug-delivery devices for injectable drugs: there are not many connectivity devices available and the majority of them
88 | Outsourcing in Clinical Trials Handbook
Figure 1: Pipeline by delivery route, 2018–19 Transdemal 1%
Otic 1%
Topical 5% Rectal 1%
Vaginal 1% Injectable 53%
2018 Oral 33% Ophthalmological 2% Inhaled 4% Otic 1%
Topical 5% Rectal 1%
Implant 1% Transdemal 1% Vaginal 1% Injectable 55%
2019 Oral 31% Ophthalmological 2% Inhaled 4% Implant 1%
are autoinjectors, which are rather costly and specifically marketed with certain drugs. For injectable drugs, usually supplied in the form of pre-filled syringes, autoinjectors are not a good fit, because developing an autoinjector for a clinical trial would take quite a long time, which would further delay study timelines. As many of the studies do not meet their predefined timelines, a uniquely developed autoinjector is not a viable option for a clinical trial drug, at least not in phase I or phase II. For this purpose, DALI has developed the
Synnect smart injection solution – Synnect is designed to fit standard, pre-filled and safety syringes, and does not need to implement changes to the drug’s primary packaging as it fits to the plunger-stopper. Synnect’s compatibility with pre-filled syringes makes it the ultimate choice for injectable clinical drugs, enabling ready-made connectivity by replacing only one
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