5 minute read 21 Oct 2021
Scientist looking in microscope

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

By Nick Davies, PhD

EY US Principal, EY-Parthenon Ernst & Young LLP R&D Strategy Leader

Scientist, strategist, entrepreneur, leader and C-suite advisor dedicated to accelerating the delivery of innovative medicines to patients. Husband, father, amateur musician and boat captain.

5 minute read 21 Oct 2021

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.

In brief:

  • EY-Parthenon survey respondents estimate that 50% of clinical trials will be hybrid or decentralized by 2024.
  • Benefits to this decentralization, including shorter execution time, are expected to outweigh additional costs.
  • Top CROs are leveraging acquisitions and strategic partnerships to develop hybrid and decentralized clinical trial solutions to better serve pharma customers.

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
Figure 1: Breakdown of clinical trial approaches

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
Figure 2a: Sponsor costs for a hybrid decentralized trial

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.

Partnering with the right vendors such as DCTs and CROs is key

The massive growth of DCTs during COVID-19 has increased activity in the space, with top CROs recently leveraging M&A deals and strategic partnerships to develop DCT solutions. By 2024, survey respondents estimate that 22% of all DCTs will be exclusively run by a pharma or biotech company sponsoring the trial, 35% exclusively CRO-run, and 44% will involve both parties.

When selecting vendors, the average CRO respondent slightly prefers working with new vendors, while large sponsors (revenue >$10b) prefer working with existing vendors and small sponsors (revenue <$1b) do not express a preference. Both sponsor and CRO respondents have a strong preference for vendors with end-to-end capabilities, defined as providing all the solutions necessary to perform clinical, safety and regulatory activities with a unified IT system to keep the data in sync. Vendor market leaders were determined by percent experience using or planning to use by sponsors or CROs.

Challenges remain

The top challenge for pharma sponsors is the ability to integrate DCT data within existing ecosystems. Other challenges include optimizing study execution in patients’ homes, obtaining clearer regulatory guidance, data protection and privacy, and the availability of solutions that facilitate compliance with regulatory guidelines. For CROs, the top three challenges are the optimization of study execution in patient homes, clearer regulatory guidance and the ability to integrate DCT data within existing ecosystems (Figure 3).

Primary interviews indicate that this is due to the complexity of more moving parts in a decentralized model, where there are multiple patient homes with personnel such as sponsor investigators, medical professionals and regulators.

Of the top challenges, clearer regulatory guidance is seen as the largest catalyst to accelerate global adoption of DCTs (38% picked as the top choice; next highest choice was 19%). Increased clarity is needed in areas such as benefit/risk assessment, protocol amendments, documentation, data/IT systems, data privacy and communication cadence. Guidance from regulators on these matters will ease uncertainties and facilitate much greater adoption of DCTs.

Figure 3
Figure 3: Challenges

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.

EY‑Parthenon Adam Berman, Alex Chen, Christina Kim and Megan Shea also contributed to this article.

Summary

Based on survey results and EY-Parthenon analysis, the future for hybrid and DCTs appears optimistic. Accelerated by COVID-19, the underlying factors supporting these types of trials have been anchored to time savings and a shift toward patient-centric approaches. Further adoption of hybrid/DCT approaches will be driven by improvements in regulatory communication and advancements in data integration and usability. Sponsors, CROs and vendors are taking the steps now to address these gaps.

About this article

By Nick Davies, PhD

EY US Principal, EY-Parthenon Ernst & Young LLP R&D Strategy Leader

Scientist, strategist, entrepreneur, leader and C-suite advisor dedicated to accelerating the delivery of innovative medicines to patients. Husband, father, amateur musician and boat captain.