It has been a turbulent time for the pharmaceutical industry – especially in regard to the clinical trial sector. From reduced investment, to a lack of public trust in the industry, it has been difficult, especially for small and medium-sized biotechs, to get efficient clinical trials off the ground.
On top of these challenges, the industry has also seen a change in demand, with the types of therapies in the pipeline, such as cell and gene therapies, requiring a shift away from the gold standard randomised controlled trial (RCT) model. As a result, companies have had to learn how to effectively run adaptive trial designs, while tackling small patient numbers and providing sufficient data to regulatory authorities.
Other challenges, including shifts with new government administrations, and new regulatory guidance and legislations are also likely to cause further upheaval in 2025.
Better trial designs will be key in 2025
As more advanced therapies move their way into the clinic, sponsors and biotechs are looking to improve trial designs to better evaluate the efficacy of a therapy.
Steve Herne, CEO at Unlearn says as a result, this is providing new problems for sponsors. “Trials are getting more complex and expensive as they target smaller, more specific patient populations, rely on larger and more diverse datasets, and navigate stricter global regulations,” Herne explains. “We’ll need to design trials that are smarter and more efficient, plan our operations carefully, and stay nimble as the landscape keeps evolving.”
It will therefore be more important than ever, especially for biotechs with less cash reserves, to ensure a higher level of confidence in therapies before clinical trial initiations. Orr Inbar, CEO, and co-founder of Quant Health, an AI-powered clinical trial design company, says: “I think we will see better science before going into a trial to ensure the right therapy and right trial is being conductive. I also think we will see a resurgence of adaptive trials such as umbrella and platform trials. CROs may be worried as CRO costs have been ballooning over the last decade. Efficiency and reducing the number of trials and trial size puts fear into the CROs.”
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