Company insight
The evolving environment of clinical trial sourcing
Myonex is a complete clinical trial supply partner with extensive experience in global drug sourcing, packaging and labelling, equipment and supplies, and clinical trial prescription services.
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n recent years, the industry has begun to explore decentralised clinical trials (DCT) as a way to increase patient recruitment and retention and improve patient data by expanding patient pools. The global pandemic has made the DCT concept, which uses telemedicine and home health visits to reduce the need for patients to travel to the study site, even more attractive. However, from protocol development to getting medications and supplies to patients, to study closure, sponsors can find themselves navigating uncharted waters. Fortunately, innovations in technology, sourcing and other areas are making DCTs increasingly feasible.
Multiple models The Clinical Trials Transformation Initiative defines DCT as studies “executed through telemedicine and mobile/local healthcare providers, using processes and technologies different from the traditional clinical trial model”. In the real world, it may not always be possible to conduct all study activities remotely. For global studies, which cross legal/jurisdictional and even cultural boundaries, a hybrid approach is often necessary. Ultimately, the goal is to design the trial to reduce the number of patient visits to the central study site as much as possible. The best way to achieve that will be different for every trial. The one common denominator is the need to work with the technology, supplies and medications provider as early in the process as possible in order to ensure that the protocol is flexible enough to adapt to contingencies.
Technology tools
From smartphones and tablets with videophone apps for virtual provider visits to wireless or stored data e-wearable
Clinical Trials Insight /
www.worldpharmaceuticals.net
A clinical trial prescription service with an expansive network of pharmacies supports convenient patient pick-up with a pharmacy benefit card specifically for clinical trials.
devices, a wide range of technology makes DCT possible. Available options include wearable devices for monitoring various blood components, airway and respiration, and even some aspects of brain function, such as regional oximetry and sedation monitoring. Other technology in this category includes digital insoles to assess gait and balance; wrist-worn monitors for activity, heart rate, blood pressure and electrodermal activity; and headbands with sensors for electroencephalography or electromyography.
Incorporating technology into a trial requires many considerations beyond simply choosing which device(s). Use of wireless devices raises questions around data plans and connectivity. For complex devices, end users (whether nurses or patients) will need training. In addition, decentralised trials might also require portable laboratory equipment for travelling nurses – a portable refrigerated centrifuge is in development. An effective sourcing strategy must weigh the costs of leasing versus purchasing any of this equipment, as well as delivering it to providers or patients and retrieving it on study completion.
Drug delivery
Sponsors may leverage a central pharmacy or contract manufacturing organisation to ship medications to a mobile nursing provider or direct-to- patient. If nurses will deliver medications, they may need transport coolers or thermal bags, and patients may need ultra-low temperature refrigerators or freezers in the home. In North America, one clinical trial prescription service makes it possible to ship open-label medications direct to site, directly to patients or to an expansive network of thousands of local pharmacies for patient pick-up with a pharmacy benefit card specifically for clinical trials. This not only increases patient convenience but also eliminates upfront bulk purchasing, overages and waste while providing access to speciality drugs. With so many variables and options for devices and drug supply schemes, a complete trial supply partner with broad, global resources is the straightest path to a successful decentralised trial. ●
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