Outsourcing
qualifications in a follow-up study, although therapeutic expertise and prior experience with a CRO are still very important to pharmaceutical companies, especially as organisations implement more remote and virtual trial approaches,” she notes. Assessing CRO expertise and choosing an outsourcing model, according to Przekop, can depend on several factors, but the therapeutic area and the study phase in particular stand out. “Those two factors often drive the complexity of the protocol and the types of patients involved, in terms of their health profile,” she says.
Latshaw II, for his part, agrees that the choice of outsourcing model will depend a large amount on the therapeutic area of the trial. “In full service, sponsors want to ensure that the outsourcing partner has domain expertise and a proven track record of navigating the clinical trial spectrum from study design to execution,” he says. “In functional service, where expertise is limited to a particular niche area, the outsourced functions remain in synergy with the therapeutic goal.” By offering specialised services and expertise in distinct areas, specialist providers ensure that specific trial functions are meticulously executed with a profound understanding of the therapeutic, regulatory, and compliance landscape. This contribution can significantly accelerate the pace and enhance the cost-effectiveness of studies. Highlighting the subtle terrain of outsourcing models, the Tufts study mentioned oncology as a driver of the full-service approach, while functional service outsourcing was synonymous with non-oncology trials. But is there something unique about oncology trials that lends itself better to this approach? “Oncology trials are some of the most complex and often involve the most ill patients,” Przekop says. “This requires highly experienced professionals to execute protocols. It also means that a high number of serious adverse events and fairly predictable outcomes are to be expected, whether related to the investigational product or not,” she explains. “As a result of these factors, Investigator Brochure updates are more complex, as are the statistical evaluations.” In oncology trials, full-service CROs are popular because such complex studies have more intricate protocols, as Latshaw II points out, requiring “specialised expertise in patient selection and biomarker analysis. The full-service approach consolidates everything and ensures continuity despite the added complexity.” They’re handy for companies lacking extensive clinical development infrastructure in these areas, he adds.
Optimise AI and QA functions Smaller companies without specialist research expertise naturally look to outsource their research programs.
Clinical Trials Insight /
www.worldpharmaceuticals.net
However, reports from McKinsey & Co. suggest such biotech businesses are dissatisfied with the offerings of the big CROs. They feel they do not provide enough strategic advice or adequately support the integration of technology point solution providers and that there is a “misalignment of incentives,” as the company noted in a survey-led report. Even as biotech and biopharma companies continue to fuel the growth of CROs, there appears to be work for CROs to do to better meet their expectations. Latshaw II believes that following the barbell strategy – an investment concept that suggests that the best way to strike a balance between reward and risk is to invest in the two extremes of high-risk and no-risk assets while avoiding middle-of-the-road choices – can position CROs to efficiently meet the needs of sponsor companies. “Look at the barbell strategy: either become a niche functional service provider or use the whole-stack CRO approach,” he says. “Try incorporating the latest and most remarkable technologies into your processes, because even if you haven’t been asked, ‘What are you doing with AI?’ you will be! Consider performance-based contracts to put your expertise where the money is.”
As sponsor companies engage with CROs in areas of expertise they lack in-house, they gain oversight over activities outside their areas of expertise.”
Penelope Przekop
To better optimise CRO use, Latshaw II advises that biotech and pharma companies be more objective in selecting CRO partners using a data-based approach rather than relying on past personal and institutional relationships. “Going with an organisation because they performed well in one engagement does not guarantee success going forward, and there are likely better potential partners out there you aren’t even considering,” he says. “Past performance is no guarantee of future results.”
For Przekop, evaluating CROs on their QA credentials should be a priority for sponsors. “Always remember, a CRO is as good as its QA function, and ensure that someone qualified makes that decision,” she says.
As with so many sectors transformed by the use of data to lead decision making, successful CROs are likely to be those that can demonstrate a history of competency in numbers. But as the pharma industry continues to grow in the direction of advanced therapeutics developed mostly by smaller biotech companies, the CROs that lead the market will be those that can adapt their services to accommodate what will be their main customers in the future. ●
69%
Tufts Center for the Study of Drug Development
33
The approximate percentage of global spending on contract clinical services ($34 billion) in 2022 by the top ten CROs
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