FUTURE SUPPLY MODELS
However, from a broader perspective, it is apparent that the use of direct-to-patient drug delivery is sluggish compared with other DCT approaches. While the idea may sound straightforward, there are many complicating factors for its execution, Zobel says. Some experts within the industry note that the challenges are multifactorial, ranging from regulators and the technology still needing to catch up, to practical challenges that may discourage uptake among trial sponsors.
Regulatory framework needed Outside of the pandemic setting, there is a lack of guidance from regulatory authorities on how to integrate remote drug deliveries into trial protocols, Zobel says. Before the pandemic, sending investigational medicinal products directly to patients was not typically mentioned in any regulatory document, she adds. Due to the lack of a regulatory framework, sponsors would need to convincingly argue their case to regulators that remote drug delivery was essential to the trial, Zobel says. There would need to be evidence supporting the idea that this decentralised element would contribute to patient safety and improve access to therapy, she adds. COVID-19 lockdown measures helped delivery within the clinical trial industry, particularly for participants who are unable to visit hospital-based trial sites to access investigational drugs, says Bhausaheb Patil, head of business operations, decentralised clinical trials solutions, at advanced analytics provider IQVIA. The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory bodies published emergency guidance that allowed for direct deliveries to happen, Zobel notes. The DCT Adoption Tracker shows that the use of remote drug delivery is higher among academic sponsors than industry sponsors. Academic centres do not have to comply with the same level of regulatory oversight in their trial design because they are not working towards commercial gain, so they are not audited and inspected as often as industry sponsors, notes Karla MacKenzie, head of site management and decentralised clinical trials Oceania at LEO Pharma. Also, academic
centres do not often stage large, multi-country trials, which increases the complexity from a regulatory aspect, she adds.
Enthusiasm for remote drug delivery varies There are countries such as Denmark that recently specially amended their regulations to allow direct-to-patient drug deliveries to happen even outside of the pandemic setting, Zobel says. Australia’s regulatory body, the Therapeutic Goods Administration (TGA), is open-minded when it comes to decentralised approaches, primarily due to the sheer size of the country, MacKenzie notes. However, there are also countries that are not as enthusiastic about remote drug deliveries. For example, a German-based patient may be blocked from being recruited from a trial based outside the country if the investigational drug would be delivered to the patient, Zobel notes. Yet the same patient can be enrolled in the trial if the patient travels to the trial site to pick up the drug, she adds. To garner more widespread regulatory
support, Lash Group’s Hanna says sponsors should collect meaningful data from trials with a direct-to-patient drug delivery component that supports the worthiness of this decentralised approach. This could be improved quality of life or even more accurate clinical outcome measures. “It’s about creating that value story. It’s about the sponsor creating
Suitability depends on dosing frequency and application procedure Some investigational drugs are better suited for remote drug delivery than others. According to the tracker, infectious disease and central nervous system trials are leading the way in terms of using this DCT approach. However, Zobel notes the ideal drug for patient deliveries is not necessarily disease-dependent, but perhaps depends more on dosing frequency, such as a therapy needing continuous treatment at home. It would also be less ideal if the medication has a complicated application procedure, she adds. One additional concern with direct-to-patient drug delivery is participant compliance. There could be questions regarding whether the patient is taking the investigational drug at the
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