How biopharmas and CROs can create value in decentralized global trials
By Nick Davies and Adam Berman, EY-Parthenon
Hybrid or decentralized clinical trials (DCT) have been a priority for biotechnology in recent years, especially as organizations focus more on delivering consistent patient care across a variety of platforms. The COVID-19 pandemic, and the resulting disruption to the entire clinical trials industry, has only further accelerated decentralization – disrupting the way biotech executives engage with contract research organizations (CROs).
The need for biopharmaceutical executives to effectively involve CROs in DCTs will only increase in the years to come. In fact, according to our recent survey of 69 pharmaceutical / biotech sponsors and CRO makers, half of all clinical trials are expected to be either hybrid or fully decentralized over the next few years.
As the clinical trials industry continues to evolve, there are several steps you and your CRO partners can take to address regulatory uncertainties, investment expectations, and advances in data and information technology related to DCTs, including alignment of regulatory stakeholders, benefit / risk assessment and data management integration strategy. . More importantly, it will be critical to develop patient recruitment and engagement strategies throughout the clinical trial journey.
DCTs should grow
Hybrid clinical trials deploy strategies from centralized and decentralized methodologies to recruit, monitor and collect data from patients. Respondents to our survey say the current clinical trial landscape is divided 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 perceived to outweigh costs
For biotechs, DCTs have several factors in their favor. DCTs offer increased patient convenience and engagement, shorter trial times, and a more diverse representation of patient populations than conventional trials. In fact, 73% of survey respondents believe the costs of CSDs are worth the benefits, which include an expected overall reduction of around 15% in the time required to complete the study. Faster patient recruitment is expected to be a major driver of this reduction in time.
Biotech and pharmaceutical sponsors have mixed perceptions about whether costs will rise or fall due to decentralization, which may mean similar or improved margins for CROs. Consistent with this thinking, most CROs surveyed indicated that project fees paid to sponsors would decrease or stay the same, while margins would likely increase or stay the same.
Investigator and site costs, including site management and monitoring expenses, are expected to be lower in a more decentralized testing environment, according to CRO leadership. On the other hand, the biggest expected increase in costs for CROs – and for sponsors – is in drug safety and quality assurance or in-home or remote services, logistics and shipping. Ongoing supply chain challenges can put pressure on logistics and shipping costs. On the supplier side, the management of patient treatment, such as telemedicine (27%), direct drug and supply logistics (25%), electronic consent (23%) and operational management of trials, such as remote monitoring (23%), are expected to experience the greatest increase in investment over the next three years.
Despite the mixed perception of the costs of DCTs, respondents believe that the benefits of decentralization, such as time savings and patient focus, outweigh any expected increases in costs.
Partnering with the right suppliers is essential
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 managed by a pharmaceutical or biotech company sponsoring the trial, 35% will be exclusively managed by CROs, and 44% will involve both parties.
When selecting suppliers, the average CRO respondent slightly prefers working with new suppliers, while large sponsors (turnover and $ 10 billion GT) prefer to work with existing suppliers and small sponsors (turnover of $ 10 billion GT). business
The main challenge for biotechnology or pharmaceutical sponsors is the ability to integrate DCT data into existing ecosystems. Other challenges include optimizing the delivery of studies 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 this is due to the complexity of more moving parts in a decentralized model, where there are multiple patient homes with staff such as sponsor investigators, healthcare professionals, and regulators.
Among the main challenges, clearer regulatory guidance is seen as the biggest catalyst to accelerate the global adoption of CSDs. Greater clarity is needed in areas such as benefit / risk assessment, protocol changes, documentation, data / IT systems, data privacy and communication cadence. Guidance from regulators on these issues will ease uncertainties and facilitate much wider adoption of CSDs.
Steps to Make DCTs a Greater Part of Drug Development
Regulatory clarity will be a key step in making DCTs and hybrid trials a larger part of the drug development protocol. Biotech and pharmaceutical sponsors and CROs need more guidance on the documentation and training needed to maintain compliance. Stakeholders, including regulatory agencies, sponsors, CROs, patients and providers, will need to align with these requirements.
In addition to early stakeholder alignment, sponsors and CROs can begin to advance the regulatory environment by taking additional DCT considerations into account throughout the study lifecycle. This includes, but is not limited to, alternatives to traditional ethical submissions, informed consent (e-consent), pharmacovigilance, protocol changes, MHRA inspections and archiving.
But even if you expect this clarity, there are other actions you and your CRO can take, including:
- Develop or use patient or provider oriented technologies that are accessible and easier to use for everyone involved in the trials. You need to prioritize the technology investments that meet the needs of these diverse audiences and that align with the core values ââof the business.
- Establish protocols for patient recruitment and engagement throughout the clinical trial lifecycle. If not already done, you should develop standard operating procedures for protocol design, taking into account 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 data, internally and externally (eg, in electronic medical records, hospital systems). This should link the points of engagement between patients, sponsor, investigators and the technology infrastructure.
- Form an incentive structure and define KPIs to realize the potential of decentralized testing by leveling the current structure of the global and local model and, in doing so, identifying weaknesses and differences from competitors.
- Conduct feasibility studies to ensure sites are ready to conduct trials, implementing ongoing site readiness assessments to ensure that sites are âcertifiedâ to conduct trials, especially those that are hybrid in nature.
Based on the survey results and our analysis, the future of hybrids and DCTs is optimistic and should lead to better patient outcomes. Further adoption of hybrid / DCT approaches will be driven by improvements in regulatory communication and advances in data integration and usability. Sponsors, CROs, and vendors can work together to take action now to close these gaps.
About the authors:
Nick Davies is Head of R&D Strategy for EY-Parthenon. He has over 25 years of experience in and with pharmaceutical companies as a scientist, strategist, entrepreneur and leader. He works extensively with healthcare and life science companies and private equity firms for upstream strategic analysis and transaction advice. Davies’ strategy, consulting and industry experience spans clinical research and development, compliance, quality, trade and marketing, business development, mergers and acquisitions, external payers, l access and regulatory environments. He holds a doctorate. in Immunology and Genetics from the University of Cambridge in England.
Adam Berman is Senior Director at EY-Parthenon, where he helps companies transform their R&D functions by developing and implementing innovative strategies. His experience in strategy, consulting and industry spans all R&D, where he has advised technology companies, large-cap pharmaceuticals and biopharmaceuticals 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.