FUTURE SUPPLY MODELS


Direct to patient: the rocky road to remote drug delivery


in clinical trials While it may have provided an obvious solution to lockdown measures, sending investigational drugs directly to study participants is still an untapped opportunity, even in trials that Reynald Castañeda.


W


ith the COVID-19 pandemic underscoring the importance of robust supply chains in clinical


trials, a way to future-proof these channels may be so obvious that it is easy to overlook. Direct-to-patient remote drug delivery, a


decentralised clinical trial (DCT) approach that allows for an investigational drug to be sent directly to the trial participant, seems like an obvious study design element addition in response to COVID-19 lockdown measures. Indeed, in the past two years, there has been an uptick of trials using this design element compared to years prior, according to Clinical 


Beyond the pandemic environment, remote  if a patient is too sick to physically go to the trial site, then such a direct-to-patient approach would be ideal, says Andrea Zobel, senior director, personalised supply chain at World Courier, a global specialty logistics provider in the US. In addition, such an approach would widen the pool of potential trial participants and ease the risk of dropout rates, she notes. Direct-to-patient deliveries also allow for


“patient-world data sets”, with the drug being used in a real-world setting, adds Dale Hanna, product strategy director at patient support services company Lash Group.


46 | Clinical Trial Supply Handbook


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