How biopharma and CROs can create value in a shift to decentralized trials

Prioritizing specific areas in the decentralized trial value chain can help biopharma and CROs to better equip themselves for the future of hybrid clinical trials.

Hybrid or decentralized clinical trials (DCTs) have been on top of the mind for biopharmaceutical companies in recent years, especially as organizations focus on providing consistent patient care across a variety of platforms. However, the interruption in trials caused by COVID-19 has necessitated faster decentralization. An EY-Parthenon poll of 69 sponsor (pharmaceutical or biotech companies) and contract research organization (CRO) decision-makers shows that half of biopharmaceutical clinical trials are expected to be either hybrid or completely decentralized by 2024.

Biopharma and their CRO partners can take several steps to address regulatory uncertainties, investment expectations, and data and IT advancements related to DCTs as the landscape evolves, including regulatory stakeholder alignment, benefit/risk assessment and data management integration strategy. More importantly, it will be essential to develop patient recruitment and engagement strategies across the clinical trial journey.

DCTs are expected to grow

Decentralized trials are clinical trials that allow patients to enroll and participate in locations such as retail pharmacies, reference laboratories close to their home or even at home beyond a centralized investigator site. This contrasts with conventional clinical trials that are conducted by collecting data from patients in a centralized location or investigator site. Hybrid clinical trials deploy strategies from both centralized and decentralized methodologies to enroll, monitor and collect data from patients. Survey respondents say the current clinical trial landscape is split as follows: 60% conventional trials, 24% hybrid trials and 16% decentralized trials (Figure 1). But by 2024, survey respondents indicate 28% and 22% of trials will be hybrid and decentralized, respectively.

Figure 1

Benefits seen as outweighing costs

DCTs offer increased patient convenience and engagement, shorter trial times and more diverse representation of patient populations than conventional trials. In fact, 73% of survey respondents believe the costs of decentralized trials are worth the benefits, which include about a 15% overall expected reduction in time required for study execution. Expedited patient recruitment is expected to be a major driver of this reduction in time. Sponsors hold mixed perceptions on whether costs will increase or decrease due to decentralization. This may mean similar or improved margins for CROs (Figure 2a). In line with this thinking, most CRO respondents indicated project fees to sponsors would decrease or stay the same, while margins would more likely increase or stay the same.

Figure 2a

Investigator- and site-related costs, including site management and monitoring expenses, are expected to be lower in a more decentralized trial environment, according to CRO executives who responded to the survey. On the flip side, the largest expected increase in costs for CROs is in drug safety and quality assurance, at-home or remote services, and logistics and shipment (Figure 2b). On the vendor side, patient treatment management, such as telemedicine (27%), direct-to-patient drug and supply logistics (25%), e-consent (23%) and trial operational management such as remote monitoring (23%), is expected to have the largest increase in investment over the next three years (Figure 2c). Despite the mixed perception on costs for DCTs, survey respondents believe the benefits of decentralization, such as time savings and focus on patient centricity, outweigh any expected increase in costs.

Figure 3

Steps to make DCTs a bigger part of drug development

Regulatory clarity will be a key step toward making DCTs and hybrid trials a greater part of the drug development protocol. Sponsors and CROs need more guidance on documentation and the training needed to maintain compliance. Stakeholders, including regulatory agencies, sponsors, CROs, patients and vendors, will need to align on these requirements. In addition to early stakeholder alignment, sponsors and CROs can start moving the regulatory environment forward by addressing additional DCT considerations across the study life cycle. This includes, but is not limited to, alternatives to traditional ethic submissions, informed consent (e-consent), pharmacovigilance, protocol modifications, MHRA inspections and archiving. 

But even as they await this clarity, sponsors and CROs can take other steps:

• Develop or employ patient- or provider-facing technologies that are most readily acceptable and easiest to use for all involved in trials. This can be accomplished by prioritizing technology opportunities that align with core business values.
  
• Establish protocols for patient recruitment and engagement across the clinical trial lifetime. This can be accomplished by developing standard operating procedures (SOPs) for protocol design and accounting for key DCT considerations, such as trial monitoring and management, distribution of clinical supplies, reporting adverse events and development of supporting documentation.
  
• Create a data management strategy both to secure patient data and to integrate the data, internally and externally (e.g., electronic medical records, hospital systems). This can be accomplished by identifying engagement points between the patient, sponsor, investigator journeys and the tech infrastructure.
  
• Form an incentive structure and KPIs to realize the potential of decentralized
  
• trials. This can be accomplished by level setting the current global and local model structure, identifying pain points and differences between competitors in the process.
• Conduct feasibility studies to ensure that sites are ready to conduct trials. This can be accomplished by implementing rolling site readiness assessments to ensure sites are “certified” to conduct trials, especially those that are hybrid in nature.