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CRO Industry Update

Digital modernization, decentralized trials and advanced therapies drive outsourcing.

Clinical trials have undergone a fundamental shift over the last year as a result of the pandemic, with many traditional processes taking on new formats to increase clinical development efficiencies. R&D costs, technology and digital modernization of clinical trials, as well as advanced therapies and personalized medicine are key areas impacting outsourcing and growth among Contract Research Organizations (CROs). In this article, top CROs provide insight on key market trends and opportunities, today’s complex trials, and the post-pandemic outlook for clinical development.

According to a recent report by Global Market Insights, “Contract Research Organization Market by Type, Therapeutic Area, End-use, Regional Outlook, Price Trends, Competitive Market Share & Forecast 2027”, the market valuation of CROs will reach $74.2 billion by 2027, with an increasing number of drugs in development coupled with growing R&D expenditure expected to boost growth.1

In addition to pharma/biopharma sponsors outsourcing R&D activities to CROs to gain flexibility and speed the drug development process, key factors impacting market trends include digital health and disruptive technologies, such as AI, advanced therapies and protocol design complexity, and the transition to decentralized clinical trials resulting from the pandemic—all of which harbor inherent complexities driving an increased reliance on CROs to help improve efficiency and productivity.

Key Market Trends
In addition to speed and cost as strong motivators for outsourcing in today’s market, COVID-19 propelled clinical development into a new and changing landscape focused decentralized clinical trial design and remote trial execution. Additionally, navigating the regulatory landscape, gaining therapy area expertise and on-demand services, such as the functional service partnership (FSP), are areas driving outsourcing.

Patient-centric decentralized clinical trials and remote trial execution are key market trends driving opportunities and outsourcing according to Murray Aitken, Executive Director, IQVIA Institute for Human Data Science. “We used to bring the patient to the trial. Now, the idea is to design trials that fit into patients’ lives and reduce burdens placed on them and sites to improve patient engagement. We are seeing a dramatic ramp-up in decentralized trial elements, whether it be telehealth technologies and virtual oversight models to assist sites and engage with patients, or home health visits to perform lab work, infusions and other home care needs. Also, the use of social media and technology-enabled referrals is increasing patient awareness, access, recruitment, and participation at a time when it’s needed most.”

Additionally, with digitization on the rise, remote trial execution is feasible. Aitken noted the use of remote capabilities throughout the entirety of a trial, from start-up to clinical monitoring and data review. Aitken said, “It’s important that CROs and sponsors avoid increased burden on sites and patients when designing such models.”

An evolving regulatory landscape requires greater agility and the ability to proactively adapt to new requirements. For example, the FDA issued 74 new COVID-specific guidance documents since March 2020. A key trend for regulatory affairs is the outsourcing of post-marketing regulatory work to maintain marketed drugs, according to Pete Lassoff, PharmD, Senior Vice President, Head of Regulatory, Syneos Health, “Renewals, labelling changes, variations, regulatory agency commitments, marketing authorization holder changes, regulatory intelligence, publishing and the full gamut of operational work, to keep products on the market, are increasingly outsourced.”

Carol Aliyar, Executive Vice President, Head of Safety & Pharmacovigilance, Syneos Health, added, “The industry has been going through fundamental change with companies reviewing core versus non-core needs. Many companies are looking at innovative ways to handle maintenance work, both regulatory and safety and pharmacovigilance for marketed products, while retaining strategic regulatory work for new, novel products.”

Importantly, automation of data capture and reporting, and leveraging innovative, advanced technologies are becoming vital capabilities to ensure compliance via accuracy and completeness of submissions. “The trends to reduced fixed costs, grow economies of scale and, more recently, leverage new technologies that allow regulatory work to be faster, more economical and of higher quality are not new. Automation, natural language processing, machine learning and even AI are transforming routine regulatory and safety tasks and driving outsourcing in our space,” said Pete Lassoff of Syneos Health.

When it comes to advanced capabilities, outsourcing provides sponsors the flexibility needed to access expertise and experience to improve quality and reduce time-to-market. Serge Bodart, Chief Commercial Officer at IDDI, said, “As the drugs become more targeted, the clinical trials become more complex and a lot of early-stage biotechnology companies lack expertise in clinical trial regulation and clinical trial design. Sponsors often turn to specialized CROs with the knowledge to fit the objective to the study design. For example, sample size re-estimation is in itself a complex model, and far from a one-size-fits-all solution. It takes experts to understand how to build the right study for the right product.”

In the FSP space, sponsors look to fill small gaps and/or large-scale programs that require dedicated capacity management, and now in particular, access highly trained professionals. Les Enterline, Vice President, Global Head of Functional Service Partnerships, PPD, said, “While we recognized fewer marketed products service requests during the pandemic, we are seeing this sector return to pre-pandemic levels and we continue to see a large volume of new RFPs and renewals across all functional areas. One area where we have seen an interesting shift from historical requests is with both large pharma and biotechs requesting more senior and experienced individuals. COVID-19 has accelerated the need for clients to have rapid access to additional highly trained professionals to support their pipelines in what already was a highly competitive market. Clients who used to request one or two “senior” professionals now are asking for 20, 30 or even as many as 90 FTEs across multiple functions. They simply cannot find and hire staff fast enough or they do not want to assume the risk of increasing internal headcount.”

Sponsors increasingly look to leverage professionals from FSP vendors to help establish and drive strategy, as well as expand into the digital/decentralized trials area.

Clinical Development Post Pandemic
The pandemic propelled the need to accelerate trial design and execution under challenging circumstances. Many traditional protocols took on new formats to increase efficiencies, namely decentralized trials supported by digital health technologies. Going forward, Murray Aitken of IQVIA expects greater acceptance of patient-centric trial elements. “Seeing how research was sustained through pandemic-related shutdowns and site closures via decentralized trial solutions, sponsors will consider how virtual they can go with their trials to best meet the needs within their therapeutic areas of focus,” Aitken said.

Carol Aliyar of Syneos added, “Post pandemic, we expect digital health technologies will play a more crucial role in increasing the efficiency and data capture for clinical trials, while creating new ways to accelerate patient access, improve enrollment and retention. Additionally, there has been an increased interest and usage of decentralized trials and collection of more real-world data. This has been an unexpected benefit of the pandemic with sponsors willing to accept these non-traditional virtual and hybrid approaches.”

“For safety and pharmacovigilance (PVG), the ability to detect, assess, understand and prevent adverse events will be of critical importance. With patient safety paramount, successfully collecting, analyzing and sharing drug safety data while aiming to reduce patient risk will be key,” added Aliyar.

The pandemic provided an opportunity to re-evaluate the way clinical research is done. While the pandemic has confirmed there is no alternative to randomized clinical trials (RCTs) in proving a drug’s benefit, it has also exposed their vulnerabilities, according to Serge Bodart at IDDI. “We expect to see more decentralized clinical trials, as well as rolling new drug application reviews potentially becoming more common. Endpoints often require access to limited specialized resources, and the cost-per-participant prohibits recruitment and affects statistical power. What’s more, narrow selection criteria and unnecessarily restrictive protocols mean clinical trials do not always reflect clinical practice.

COVID-19 has demonstrated that RCTs, in their current form, are inflexible and inefficient. But, in the face of necessity, it has also shown that it’s both possible and advisable to embrace new ways of designing, conducting, analyzing and reporting clinical trials. This will have a long-lasting effect on our industry,” Bodart said.

Capabilities Needed for Today’s Complex Trials
With growth in both the number of clinical trials and clinical trial data volume, investing in technology has become essential to advancing drug development. According to Tufts Center for the Study of Drug Development, ever more complex clinical trial designs are collecting much higher volumes of data from a variety of sources, intensifying pressure on drug sponsors to meet speed and efficiency goals.2 Phase III clinical trials currently generate an average of 3.6 million data points, three times the data collected by late stage trials 10 years ago, according to a recent Tufts CSDD study.

Murray Aitken of IQVIA said, “Tech-enabled services and capabilities such as artificial intelligence (AI), machine learning, decentralized trials, telehealth, direct-to-patient models and remote monitoring, not only kept trials moving during the pandemic, but in some cases, accelerated timelines while maintaining data quality and patient safety. While integration and use of these elements increases, it’s equally important for CROs to provide related expertise to ensure the industry’s high quality data standard is maintained, if not elevated, while updating ecosystems in trial design and execution.”

Investment in technology is at the top of the list according to Serge Bodart at IDDI, “Decentralized clinical trials offer flexible tools to screen, enroll and engage patients. These tools also streamline communication between the different stakeholders in a clinical trial. The pandemic has exacerbated the need for tools to be even more flexible. Such systems are becoming more affordable over time but, more importantly, vendors have gained valuable experience in making technology more reliable.”

Additionally, disruptive technologies such as AI are helping to resolve challenges inherent to the clinical trial process. According to Murray Aitken at IQVIA, “Embracing intelligent, intuitive technologies, sponsors and CROs are able to better orchestrate outcomes with heightened productivity and efficiency. The seamless integration of systems and data and interoperability is replacing disparate point solutions. Sponsors and service providers are working to evaluate the implications of these opportunities, both in terms of the technologies themselves, but more importantly, how to integrate and normalize the data from these sources such that valuable insights are fully visible and can be obtained to support more streamlined decision making and effective process improvement.”

Notably, navigating the regulatory landscape is another essential focus area for today’s complex trials. According to Pete Lassoff of Syneos Health, “Staying atop of government and regulatory agency guidelines, regulations and rules to predict developments and submissions will be of paramount importance, as will the ability to work with teams from across organizations, including clinical development, pharmacovigilance, nonclinical, and CMC/Quality, among others, to ensure the effective and efficient delivery of complex studies.”

Conclusion
The pandemic reshaped clinical trials and boosted the adoption of technology solutions for greater flexibility and improved data quality. Also, personalized medicine is rapidly evolving, significantly impacting trial design, drug approval and health technology assessment. For example, in 2020, 31 of the 53 (58%) novel drug approvals by FDA’s Center for Drug Evaluation and Research were approved to treat rare or orphan diseases.3 Often these therapies require specialized development services and complex trial designs. With these and other industry trends, specialized services focusing on areas of expertise will remain a strong suit for CROs going forward. 

ICON to Acquire PRA Health Sciences

ICON recently entered an agreement to acquire PRA Health Sciences Inc. in a cash and stock transaction valued at approximately $12 billion.

The consolidation brings together two growing organizations to create a healthcare intelligence and clinical CRO. Their combined focus will be on applying transformational technology and innovation to execute clinical trials from Phase 1 to post-approval studies.

With increased functional, geographic and therapeutic scale, as well as expansive healthcare technology, the combined company will be able to offer enhanced capabilities and services to meet customer needs. In addition, through a combination of mobile and connected health platforms, a global site network, home health services and wearables expertise, the combined company will offer differentiated decentralized and hybrid trial services.

“While we look forward to bringing the strengths of the combined company to customers, we are committed to remaining fully focused on achieving project delivery goals for all customer studies, both now and in the future,” said Dr. Dave Cutler, CEO, ICON plc.


References:
  1. www.researchandmarkets.com/reports/5232503/north-america-pharmaceutical-contract-research#pos-0
  2. Rising Protocol Design Complexity is Driving Rapid Growth in Clinical Trial Data Volume January/February Vol. 23 No. 1.  https://csdd.tufts.edu/s/Impact-Report-JanFeb-2021-Final-Summary.png
  3. www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2020

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