Key among the drug development trends shaping the CRO sector, are patient-centricity in clinical trials, the use advanced technologies and methodologies, as well as increasing complexity of clinical trials. The need for sponsors to improve overall trial timelines and gain access to specialized expertise is expected to continue to drive growth for CROs.
 
Sebastien Coppe, Chief Executive Officer at One2Treat, share insight on today’s drug development landscape and the role CROs play in supporting sponsor needs. 
 
Contract Pharma: What are the pharma/biopharma R&D trends impacting CROs and services?
 
Sebastien Coppe: One of the most significant trends impacting clinical research is the shift towards patient-centricity in clinical trials. This approach emphasizes the inclusion of patient perspectives throughout the research process, from trial design to market access. It is therefore critical to prioritize integrating patient input in the trial design, as it is crucial for developing treatments that truly meet their needs. Furthermore, regulatory bodies are increasingly advocating for patient-focused approaches, as reflected in recently published guidelines. These guidelines drive the demand for CROs to adopt more advanced, patient-centered methodologies, ensuring that new therapies are not only effective but also align with what matters most to patients, e.g., quality of life.
 
Contract Pharma: What are the technology trends impacting clinical trials today?
 
Sebastien Coppe: While discussing patient-centricity is essential, implementing these ideas through actionable steps is crucial. By integrating advanced technologies and innovative statistical methodologies to revolutionize clinical trials, we can enhance patient-centricity by incorporating multiple key outcomes into a single comprehensive primary analysis, providing a more nuanced understanding of treatment effects. This holistic assessment increases the clinical relevance of our analyses and significantly reduces sample sizes, improving overall trial timelines and accelerating time to market.
 
Contract Pharma: What factors do you anticipate will drive growth in the CRO sector?
 
Sebastien Coppe: Several factors will drive growth in the CRO sector in the coming years. As previously mentioned, the growing emphasis on patient-centricity in clinical research requires more sophisticated methodologies and personalized approaches, prompting biopharma companies to seek external support to connect with patients in different ways. Secondly, the increasing complexity of clinical trials requires advanced technological solutions and specialized expertise which CROs are well-positioned to provide.
 
Thirdly, the regulatory landscape is evolving, with agencies advocating for more comprehensive benefit-risk assessments and patient-focused outcomes to be included in the pre-approval development phase. This is influenced by the changes occurring on the HTA side, both in the EU and in the USA, with the Inflation Reduction Act (IRA).
 
By staying at the forefront of these trends, CROs can continue to deliver value to biopharma companies, driving growth and innovation in the sector.