DRUG DELIVERY DEVICES
the prospect of making multiple, time-consuming visits to clinical sites and sometimes also lacking easily available and affordable transportation, many patients decline to participate or find they cannot keep to the schedule. By eliminating or reducing the need for patients to come to clinical sites, decentralised trials solve those issues. A study by the Economist Intelligence Unit of 4,000 clinical trials found it took an average of four months to recruit 100 patients to decentralised trials compared with seven months for traditional in-clinic trials.
Multifaceted benefits of patient-centric decentralised trials Decentralised trials are defined as patient-centric trials in which virtual and physical elements are used to conduct the trial procedures. These elements simultaneously simplify patient participation and increase patient engagement, making it easier for patients to integrate the trial routine into their daily lives. In solving many patient participation challenges and improving patients’ experience, decentralised clinical trials can also significantly reduce the operating costs of trials – with direct and indirect savings in the per-patient cost of recruitment, retention, site operation, workforce, data collection and more. What’s more, by reducing delays, decentralised trials can save pharmaceutical companies up to $8m in lost revenue typically incurred each day a drug launch is delayed (according to an article in Applied Clinical Trials).
An additional benefit of decentralised trials is increased patient diversity. With no or less need for patients to come to clinics or for medical professionals to visit patients in their homes, clinical trials are more accessible to people in rural areas and remote locations. The wider geographic reach creates a larger pool of potential participants and opens trials to patients from a broader range of ethnic and socio-economic backgrounds.
Decentralising trials of injectable drugs Today, biologics and biosimilars account for more than 50% of drugs being developed. Of those, most are injectables, the majority in formulations suited to self-injection. Ideally, clinical trial conditions should reflect the intended use conditions. Therefore, for self-injectable drug
formulations, decentralised remote or hybrid trials may be preferred as they allow in-home injection by the patient or home caregiver.
Safety first with injectables Of course, in every clinical trial, patient safety is paramount. In the case of studies of self- injectable drugs, the trial protocols should call for safety-engineered injection devices – both safety needles and safety syringes. Such safety devices protect patients, family members and caregivers from needle-stick injuries before and after injection and give patients more self- confidence. By hiding the needle, they can reduce anxiety related to needle phobia and reduce perception of pain. DALI’s SAN® (Safe Auto Needle) family of safety injection devices enable a safe and easy-to-use injecting experience for a wide range of formulations. Designed for use with a variety of syringes and primary drug containers, including conventional plastic hypodermics, single- or dual-chamber prefilled syringes made of glass or plastic, and vials, SAN devices are well suited for use by patients and in-home caregivers under decentralised trial conditions. They offer a unique variety of features, such as automatic needle insertion, passive-automatic sharps protection, a fully hidden needle throughout the whole injection process, and manual control of the injection speed. The wide range of products in the SAN family includes the SAN-L, the only passive safety and automatic needle-insertion device compatible with luer-lock syringes, and the SAN-P, an automatic needle-insertion safety syringe for staked needle prefilled syringes.
Digital health technology enablers for decentralised drug trials
Along with the advantages already noted, decentralised remote trials have their own challenges around distribution, compliance, patient safety, monitoring, data integrity and security. Many of these challenges can be solved with the help of digital technologies – computing platforms, connectivity, software and sensors – often called the Internet of Medical Things (IoMT).
Some elements of the IoMT are already familiar to patients. For example, pulse and blood pressure monitors that are connected for
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