TECHNOLOGY & INNOVATION Ram Raju, former senior vice president and


community health investment officer at Northwell Health agrees that the industry is seemingly reverting back to its normal practices. “Principal investigators are very much afraid about the lack of control of the patient population because they think the clinical trials do not have enough oversight. The second part of this is that they also believe that patients may not use some of the technology correctly and create patient safety issues,” Raju explains. While technology has its setbacks and can sometimes lack the precision of human action, there are areas in which technology surpasses human error. The anecdotal lack of oversight and the concerns over patient interaction with technology seem to be a blanket for a separate concern of how elements of decentralisation, such as technology, will impact the job market, adds Raju. “In the US, the cost of human service


always goes up while the cost of technology is always coming down. Eventually, intuitively, the cost will be lower in the long run,” adds Raju, who was a panellist at the 15th Annual Outsourcing in Clinical Trials East Coast conference. Ultimately, the aim is to do more with less money. As per the experts, this leads the industry in the current ‘fit for purpose’ direction of decentralisation that emphasises minimising burdens for sites and maximising benefits for patients.


Fit for purpose Because every protocol is different, there is no standard protocol design to base every hybrid trial on, says Palmese. Patient burden should be evaluated upon each visit, with decentralised elements potentially being included on a visit-by-visit basis instead of on wholesale for an entire study. When designing a protocol, the trialist must think about the solution, the patient journey, site, and the applicability of decentralisation, which is easier to do in some therapeutic areas than other. Clinical Trials Arena’s exclusive DCT Tracker


found that in H1 2022, the top therapy area for DCT adoption was metabolic disorders,


Patients are an important stakeholder, and the start of decentralization is largely attributed to increasing patient engagement bringing clinical trials to patients


followed in sequence by central nervous system (CNS), genetic disorders, infectious disease, and hormonal disorders. According to Palmese, there is good reason why decentralisation has more commonly been applied in these indications, and it comes down to how trials in these indications are designed. Oftentimes with CNS conditions such as


Alzheimer’s disease, the studies are designed to be longer because changes in disease progression are slow and must be evaluated over a long period of time, which correlates with longer follow up periods. Additionally, these trials implement many rating scales and cognitive assessments, some of which can be conducted remotely because they do not require the “intense” treatment programs that are seen in oncology trials, says Palmese. The key is flexibility, balancing the


collection of valid data while providing the patient choices to facilitate the trial process. However, this must all be done with regulatory aspects in mind: Harrison highlights the impossibility of implementing one method of e-consent across geographic boundaries. Clinical trials must be mindful of regulatory


guides and consider how technology such as e-consent is deployed, how it is used to assess data, and how the data is managed. How these processes are carried out varies from country to country. What trials need to do is learn how to work within the rules and write decentralised solutions and protocols in ways that limit biases and allow all involved stakeholders to reap the most benefit.


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