In addition to pharmaceutical and biopharmaceutical sponsors outsourcing clinical trials to Contract Research Organizations (CROs) to gain flexibility and speed the drug development process, key factors impacting market trends include technology and digital modernization of clinical trials, advanced therapies and protocol design complexity, and the transition to decentralized trials resulting from the pandemic. Each of these trends harbor inherent complexities, driving an increased reliance on CROs to help improve efficiency and productivity.
 
Serge Bodart, Chief Commercial Officer at IDDI Group discusses key market trends and opportunities, today’s complex trials, and the post-pandemic outlook for clinical development.
 
Contract Pharma: What are the key market trends impacting clinical trials?
 
Serge Bodart: The COVID-19 crisis has shaken our industry; one outcome is that it has boosted the adoption of eClinical Systems. Today, successful clinical trials are the ones using state-of-the art clinical trial management systems and eClinical Solutions in order to provide sites with flexibility while improving data quality.
 
Precision medicine is another inevitable way forward as we learn more about the molecular basis of diseases and develop better medications that target pathogenic mechanisms. Personalized medicine is also evolving rapidly and promises to have a significant impact in trial design, drug approval and health technology assessment, as well as in the clinic. 
 
CP: What are the current drug development challenges?
 
SB: As drugs become more targeted, clinical trials become more complex. But a lot of early-stage biotechnology companies lack expertise in clinical trial regulation and in clinical trial design.
 
Sponsors often turn to specialized CROs because they offer the knowledge to fit the objective to the study design. For example, sample size re-estimation is in itself a complex model, and far from a one-size-fits-all solution. It takes experts to understand how to build the right study for the right product and that is why they want a specialized CRO with a laser focus on the subject.
 
CP: What do you anticipate for clinical development post-pandemic?
 
SB: The challenge of the COVID-19 crisis represents an exceptional opportunity to question the way we carry out clinical research. While the pandemic has confirmed there is no alternative to randomized clinical trials (RCTs) in proving a drug’s benefit, it has also exposed their vulnerabilities.
 
We expect to see more decentralized clinical trials, as well as rolling new drug application reviews potentially becoming more common. Endpoints often require access to limited specialized resources, and the cost-per-participant prohibits recruitment and affects statistical power. What’s more, narrow selection criteria and unnecessarily restrictive protocols mean clinical trials do not always reflect clinical practice.
 
COVID-19 has demonstrated that RCTs, in their current form, are inflexible and inefficient. But, in the face of necessity, it has also shown that it’s both possible and advisable to embrace new ways of designing, conducting, analyzing and reporting clinical trials. This will have a long-lasting effect on our industry.
 
CP: What capabilities are needed for today’s complex clinical trials?
 
SB: Investment in technology is top of the list. Decentralized clinical trials offer flexible tools to screen, enroll and engage patients: these tools also streamline communication between the different stakeholders in a clinical trial.
 
The pandemic has exacerbated the need for tools to be even more flexible. Such systems are becoming more affordable over time but, more importantly, vendors have gained valuable experience in making technology more reliable.
 
CP: What’s critical to driving clinical trial efficiency?
 
SB: Growth in clinical trial data volume is at the forefront here. Large datasets promise to revolutionize our understanding of diseases and treatments, but the implication of this knowledge to drug development is still unclear. Results are only as good as the quality of the data.
 
Arguably, data availability and curation may improve considerably over time, especially concerning measurements of biomarkers and ascertainment of outcomes. In addition, the identification of rare side effects and the generation of new hypotheses to be tested prospectively might become important consequences of using big data.
 
But real-world evidence is inadequate in assessing causal links between treatments and outcomes. The methods of causal inference can be applied to real-world data in an attempt to overcome selection biases and spurious correlations – and this approach can prove very useful to generate hypotheses – but it cannot, and should not, replace randomized evidence to confirm and quantify the benefits and harms of new therapies.
 

---

Serge Bodart has worked in the Pharmaceutical Industry for 20 years. He co-founded SYMFO, a European-based electronic Patient Reported Outcome (ePRO) provider where he has been involved in all aspects of the electronic Clinical Outcome Assessments (eCOA) life cycle from concept to commercialization. As an internationally recognized thought-leader, he acted as the eCOA Subject Matter Expert and Scientific advisor for companies such as Biomedical Systems, Bracket Global and Signant Health. In his career, he also gained extensive International expertise in business development. He currently serves as Chief Commercial Officer at IDDI, an eClinical and Biostatistics services CRO based in Raleigh, NC and in Belgium.