“3 Key Trends” with Claude Price

What are “3 Key Trends” shaping the CDMO industry in 2024 and beyond? Quanticate’s vice president and head of clinical data management, Claude Price, shares his thoughts with Contract Pharma.

Expanding use of Real World Evidence (RWE)
Real World Evidence (RWE) is already revolutionizing clinical research by enabling the use of health data from a variety of sources such as electronic health records, insurance claims, wearables, and patient registries. This data can provide valuable insights into drug effectiveness, safety, and treatment patterns across diverse populations. In 2024, we expect to see regulatory bodies further embracing RWE to complement traditional clinical trial data, streamlining the drug approval process and enhancing post-market surveillance. The shift towards RWE will also encourage collaborations between biotech firms, technology companies, and healthcare providers, fostering a more integrated approach to research and patient care.

Integration of artificial intelligence and machine learning
We’ve seen an increase across the industry of companies exploring the multitude of ways artificial intelligence (AI) and machine learning (ML) technologies can be adopted and implemented into various stages of clinical trials with the aim of enhancing data analysis capabilities and improving the efficiency and accuracy of trials. A key area of focus with AI is the use to design and optimize trials, from patient recruitment to protocol development and real-time monitoring of trial data. Machine learning algorithms can predict patient outcomes, identify potential adverse events more rapidly, and optimize dosing regimens. This leads to not only more efficient trials, but also more personalized medicine, as treatments can be tailored to the individual characteristics of patients. Additionally, AI tools offer the prospect of reducing costs and shortening timelines, making clinical trials more accessible and scalable.

Focus on patient-centric trials
As the industry continues to evolve, there is a growing emphasis on patient-centricity in clinical trials. This trend involves designing studies, that are more aligned with the preferences and needs of patients, which can improve recruitment and retention rates and enhance the overall quality of data. In 2024, we anticipate a greater adoption of decentralized trials, which use digital tools to allow patients to participate in studies remotely. This shift not only makes participation more convenient for patients, but also broadens the demographic diversity of clinical trial populations, leading to outcomes that are more representative of the general patient population. Furthermore, engaging patients more actively in the design of trials and the decision-making process ensures that studies are more aligned with patient priorities, potentially accelerating the acceptance and adoption of new therapies.