Running a clinical study is expensive and requires sponsors, vendors, CROs, and sites to move in tandem to ensure trial success.
Three panelists discussed the key drivers behind successful outsourcing strategies at the 13th Annual Clinical Trials in Oncology East Coast 2024 conference, being held 9 – 10 July in Burlington, Massachusetts.
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Though post-pandemic inflation has led to adjustments in the total trial costs, the final determinants of a budget are typically the protocols, procedures, product complexity, and the human hours required to conduct a study, said Claudia Hesselmann, founder and CEO, ARENSIA Exploratory Medicine. However, while the aforementioned factors should be the variables determining cost, it is more often bureaucracy and inefficiency that lead to increased costs, she explained.
A study can be operationally efficient and cost-saving if it is planned accordingly, has an appropriate feasibility processes, an effective patient visibility strategy, and the necessary site relationships, Hesselmann said. This means “separating needs from wants” and determining what processes are truly integral for decision making and data collection, added Kevin Stephenson, Executive Director, Data Management, Karyopharm Therapeutics.
“As an early company, you need to be very clear on what you have, what you can afford, and what you’re going to be able to pay,” said David Sherris, PhD, Board of Director, SiVEC Biotechnologies. But an established trust between the CRO and sponsor is equally critical.
Stephenson stressed that the partnership between the vendor and sponsor must be a functioning relationship. While many vendors look the same on paper, direct communication with a prospective partner can give a sponsor insight into what the vendor might bring to the relationship outside of the applied skillsets they have on paper, he elaborated. Also noteworthy is that vendors need to be assessed individually to gauge their applicability for a particular site, added Sherris.
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By GlobalDataA “human touch” is also required—knowing the site and the principal investigators—to determine if a proposed vendor is a good fit for a study, said Hesselmann. This human relationship can help sponsors understand a participant’s motivation for enrolling in clinical studies, she explained.
