Clinical trials have undergone a fundamental shift over the last year as a result of the pandemic, with many traditional processes taking on new formats to increase clinical development efficiencies, such as designing trials to be more patient-centric. R&D costs, technology and digital modernization of clinical trials, as well as advanced therapies and personalized medicine are key areas impacting outsourcing and growth among Contract Research Organizations (CROs).

ICON’s Chief Medical Information Officer, Dr. Greg Licholai, discusses considerations for the future of clinical trials, the capabilities needed and the company’s acquisition of PRA Health Sciences.

Contract Pharma: What are the key market trends and challenges driving opportunities and outsourcing?

Dr. Greg Licholai: The outsourcing market has become more agile. Traditionally, pharma companies would hire extra staff to help run trials internally or outsource full projects to CROs. Now we’re seeing a trend towards functional service provision (FSP) where companies are looking for specific expertise and will outsource only what they need. That way companies retain ownership, infrastructure, and central control. We’re also seeing more inquiries into how to utilize technology and data for decentralized and hybrid clinical trials. As one of the world’s largest CROs, we have leveraged our breadth and technical expertise to help pharma companies adapt to the changing landscape and become more efficient in their R&D programs.

Contract Pharma: What do you anticipate for clinical development post pandemic? (i.e. decentralized clinical trials)

Dr. Greg Licholai: The future of clinical trials post-pandemic will see companies considering five key points to increase study success: deciding endpoints, protecting intellectual property, determining specific patient population needs, study design, and understanding regulatory considerations. The COVID-19 crisis has heightened the demand for an alternative to the traditional, on-site model. This has paved the way for hybrid and decentralized models to be considered as a viable option in almost all types of trials. 

Contract Pharma: What capabilities are needed for today’s complex clinical trials?

Dr. Greg Licholai: Today’s clinical trials demand two intertwined priorities. Firstly, a mindset of innovation and creativity, not just in terms of technology, but in terms of how CROs operate in partnership with companies. Secondly, patient centricity, offering personalized medicine to meet the needs of the patient in an ever-changing environment. Bringing patients, their advocates and caregivers to the table and involving them more when designing trials. We have to meet patients where they are and take away the barriers of participation. Lastly, the intersection of clinical trials and real-world evidence will be critical to see the entire patient journey. CROs will have to expand their data capabilities and their partnerships with data providers to give companies a deeper view of patient healthcare journey – that will improve outcomes and patient health overall. As clinical trials increase in complexity, CROs have an important part to play by providing advice to companies and guiding them through this ever-changing landscape.

Contract Pharma: What were the driving factors influencing the acquisition of PRA?

Dr. Greg Licholai: Our separate organizations already had similar customer-centric cultures and complementary offerings, so our approaches to growth and client service were very much aligned right from the start. Together, the new ICON is in the best position to create a new paradigm for bringing clinical research to patients and consumers and to meet market demands—while providing companies and partners with broader therapeutic offerings, greater geographic coverage, as well as enhanced clinical and commercial solutions.

Contract Pharma: In what specific areas does the combined company gain expertise and scale?

Dr. Greg Licholai: We’re working at a greater scale than our competitors, in more locations with broader and deeper expertise from the industry’s brightest talent. Our 38,000 staff members across 47 countries are operating as one to transform clinical trials and accelerate commercial success. We have a renewed focus on leveraging data, technology, and giving access to diverse patients to speed up drug development and bring much needed medicines to market. Our combined expertise across therapeutic areas including oncology, cardio-metabolic, vaccines and infectious diseases, rare disease, neurology (to name just a few) means we have a team that can advise and be true partners in developing differentiated trial solutions with our clients.