The clinical trial design terrain is evolving. The US Food and Drug Administration (FDA) is trying to increase trial diversity, expedite the delivery of effective treatments to patients, and in the midst of this, with Project Optimus, the agency aims to alter the drug development mentality that “more is better.”
In previous decades, the developmental paradigm for cytotoxic agents followed the hypothesis that higher doses would increase the probability of reducing tumour burden, said Jim Eamma, Executive Director, Therapeutic Strategy Lead, Oncology & Hematology at Worldwide Clinical Trials. However, with increased toxicity going in hand with increased dosage, and more biological, immunological, and molecularly-targeted therapies being developed, the field discovered that more is not necessarily better, he elaborated.
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Eamma was speaking about the key challenges and solutions for complex and adaptive clinical trials at the 13th Annual Clinical Trials in Oncology East Coast 2024 conference, being held 9 – 10 July in Burlington, Massachusetts.
In 2021, the FDA Oncology Center of Excellence’s (OCE) launched Project Optimus to reform the dose optimisation and dose selection for oncology candidates. Eamma said the impact of the Project will be seen in how it changes the time needed in drug development; the time it takes to increase dose escalation levels, employ backfill cohorts, and ultimately take a product to market.
Additionally, Eamma spoke about the role clinical sites play in a trial’s success. A clinical study gains initial traction when pharma and biotech sponsors engage with their principal investigators, and study coordinators to build the foundational solutions and relationships to accelerate the trial’s momentum, explained Eamma. Also, critical to ensuring trial efficiency and site selection is the utilisation of data and satellite sites, which Eamma likens to “fishing with a bigger net.”
“Think about using satellite sites because it might help accelerate enrolment. And that’s the whole idea, getting enrolment months down from 18 to 12 months.”
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By GlobalData“The idea is that 20% of your sites do 80% of the work, and that model just doesn’t apply to clinical research. We have to avoid that. We need to put together the strongest site list possible so that 80% of our sites are enrolling and engaged.”
