By Nick Davies and Adam Berman, EY-Parthenon
Hybrid or decentralized clinical trials (DCTs) have been top of mind for biotechs in recent years, especially as organizations increase their focus on providing consistent patient care across a variety of platforms. The COVID-19 pandemic, and its resultant disruption to the entire clinical trial industry, only further accelerated decentralization — upending how biotech executives engage with contract research organizations (CROs).
The need for biopharma execs to effectively engage CROs in DCTs will only increase in the years to come. In fact, according to our recent survey of 69 sponsor pharma/biotech companies and CRO decision makers, half of all clinical trials are expected to be either hybrid or completely decentralized within the next few years.
As the clinical trials industry continues to evolve, you and your CRO partners can take several steps to address regulatory uncertainties, investment expectations, and data and IT advancements related to DCTs, including regulatory stakeholder alignment, benefit/risk assessment, and data management integration strategy. Most importantly, it will be essential to develop patient recruitment and engagement strategies across the clinical trial journey.
DCTs Expected To Grow
Hybrid clinical trials deploy strategies from both centralized and decentralized methodologies to enroll, monitor, and collect data from patients. Our survey respondents say that the current clinical trial landscape is split as follows: 60% conventional trials, 24% hybrid trials, and 16% decentralized trials. But by 2024, survey respondents indicate that 28% and 22% of trials will be hybrid and decentralized, respectively.
Benefits Seen As Outweighing Costs
For biotechs, DCTs have several factors in their favor. 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 DCTs 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.
Biotech and pharma sponsors hold mixed perceptions on whether costs will increase or decrease due to decentralization, which may mean similar or improved margins for CROs. 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.
According to CRO executives, investigator- and site-related costs, including site management and monitoring expenses, are expected to be lower in a more decentralized trial environment. On the flip side, the largest expected increase in costs for CROs — and to sponsors — is in drug safety and quality assurance or at-home or remote services and logistics and shipment. Ongoing supply chain challenges may put pressure on logistics and shipment costs. 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%), are expected to have the largest increase in investment over the next three years.
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 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% will be 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 >$10 billion) prefer working with existing vendors and small sponsors (revenue <$1 billion) 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.
The top challenge for biotech or 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. 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. 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.
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. Biotech and pharma 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 ethics submissions, informed consent (e-consent), pharmacovigilance, protocol modifications, MHRA inspections, and archiving.
But even as you await this clarity, you and your CRO can take other steps, which could include:
- Developing or employing patient- or provider-facing technologies that are accessible and easiest to use for all involved in trials. You should prioritize technology investments that meet the needs of these diverse audiences and that align with core business values.
- Establishing protocols for patient recruitment and engagement across the clinical trial life cycle. If not already in place, you should develop standard operating procedures for protocol design, accounting for key DCT considerations such as trial monitoring and management, distribution of clinical supplies, reporting of adverse events, and development of supporting documentation.
- Creating a data management strategy, both to secure patient data and to integrate the data, internally and externally (e.g., in electronic medical records, hospital systems). This should connect the engagement points between patients, sponsor, investigators, and the tech infrastructure.
- Forming an incentive structure and setting KPIs to realize the potential of decentralized trials by level-setting the current global and local model structure and, in the process, identifying pain points and differences to competitors.
- Conducting feasibility studies to ensure sites are ready to conduct trials, through implementing rolling site readiness assessments to ensure sites are “certified” to conduct trials, especially those that are hybrid in nature.
Based on survey results and our analysis, the future for hybrid and DCTs is optimistic and should lead to greater patient outcomes. 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 can work together to take steps now to address these gaps.
About the Authors:
Nick Davies is the EY-Parthenon R&D strategy leader. He has more than 25 years of experience working in and with pharmaceutical companies as a scientist, strategist, entrepreneur, and leader. He works extensively with healthcare and life sciences companies and private equity firms for both front-end strategic analyses and transaction-related advice. Davies’ strategy, consulting, and industry experience covers research and clinical development, compliance, quality, commercial and marketing, business development, M&A, external payer, access, and regulatory environments. He holds a Ph.D. in immunology and genetics from Cambridge University in England.
Adam Berman is a senior director at EY-Parthenon, where he helps companies transform their R&D functions by developing and implementing innovative strategies. His strategy, consulting, and industry experience spans across R&D, where he has advised technology companies, large-cap pharmaceuticals, and biopharma enterprises on their R&D processes and IT services. He holds a BA in history from Union College.
The views expressed by the authors are not necessarily those of Ernst & Young LLP or other members of the global EY organization.