Outsourcing
Recent works by the Tufts Center for the Study of Drug Development (CSDD) gave some insight into the performance and growth rate of the CRO market. The report revealed that the 10 leading CROs generated $34bn in 2022, which represented an estimated 69% of total revenue spent on contract clinical services globally. The report also looked at growth over the five-year period between 2017 and 2021, in which total revenue increased by 12%, with a 17% growth rate observed between 2020 and 2021 specifically. In terms of market penetration, a 2017 analysis from
CRO PAREXEL suggested that about 64% of all clinical development was outsourced, and that was after a 2015 prediction from Research and Markets forecasted that 72% of clinical trials would be outsourced by 2020. Where the dial actually landed in 2020 and beyond is unclear, but we can safely assume that more than half of all clinical trials are currently outsourced, and it could even be closer to three quarters. This statistic underscores the immense trust and reliance sponsors place on CROs in the pharmaceutical research and development ecosystem.
“Opting for full service versus functional service is often decided on a case-by-case basis and depends on the internal capabilities of the company, willingness, and ability to allocate them, and overlap with the needs of the trial.”
Dave Latshaw II
Full service versus functional service In the dynamic landscape of modern clinical trials, sponsors face many decisions. Importantly, they must strategically decide on involving a CRO partner early, select the most suitable outsourcing model, and evaluate pertinent factors to inform their choices. “Opting for full service versus functional service is often decided on a case-by-case basis and depends on the internal capabilities of the company, willingness, and ability to allocate them, and overlap with the needs of the trial,” says Dave Latshaw II, CEO of BioPhy. In past decades, these two primary models have characterised the approaches to outsourcing. Full service was the most common, but that’s becoming less so as large pharmaceutical companies bring more R&D back in-house to retain regulatory vigilance over a growing number of complex trial designs and an escalating volume of data points. “The proliferation of modalities away from primarily small molecules has created an environment where niche expertise is needed to work with these new technologies,” explains Latshaw II, who spent several years as AI drug development lead at Johnson & Johnson before taking on his executive role. “There is naturally less familiarity
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with those technologies among CROs until they become more mature and gain experience, limiting their ability to be full service, hence the shift to more specialised functional service,” he adds. Penelope Przekop is CEO of PDC Pharma Strategy, a consultancy focused on areas of compliance known as GxP (Good x Practice), as well as quality assurance (QA) during trials. For her, another reason for the move away from full service to functional service outsourcing models has to do with CROs not meeting the industry’s expectations. “As sponsor companies engage with CROs in areas of expertise they lack in-house, they gain oversight over activities outside their areas of expertise,” says Przekop. GxP vendors cover Good Manufacturing Practices, Good Laboratory Practices, Good Pharmacovigilance Practices and Good Clinical Practices. Przekop explains that although there’s a growing trend of large pharma companies bringing R&D back in-house, many of the highly experienced pharma professionals with the knowledge to provide oversight on GxP compliance and quality assurance are approaching retirement, which is leaving a gap in knowledge that needs to be filled
Choosing an outsourcing model Whether sponsors opt for a full service or functional service provider will always depend on a number of factors, with cost being a major consideration. It’s common for (bio)pharmaceutical companies to thoroughly assess the overall budget and cost structure, including potential hidden costs associated with each model.
In addition, a clinical trial project can change due to evolving scientific insights, regulatory adjustments, or emerging patient needs. These variables require a nuanced approach to project management that prioritises adaptability.
“The strategic selection of an outsourcing model must align with the industry’s evolving landscape, ensuring adaptability and robust scalability to effectively address changing priorities,” says Latshaw II. “A flexible outsourcing approach can accommodate dynamic shifts in project focus and seamlessly expand to meet the demands of growing projects, without compromising efficiency or quality.” Speak to Mary Jo Lamberti, research associate professor at Tufts Center for the Study of Drug Development at Tufts University, and it becomes clear that the ongoing trend toward decentralised trials continues to influence the outsourcing decisions of pharma companies. “In a survey we conducted last year, sponsor companies look to CROs to adopt a proactive approach to decentralised clinical trial (DCT) adoption,” she says. “This requires CROs to take the initiative and anticipate needs or challenges before they arise. We need to revisit these
Clinical Trials Insight /
www.worldpharmaceuticals.net
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