Among the trends impacting clinical trials today are an increased focus on diversity of patient populations, an increase in functional service and hybrid FSP/full-service outsourcing, as well as increased protocol and regulatory complexity and the use of technology solutions to improve efficiency and reduce costs. 

Thermo Fisher Scientific’s PPD clinical research business SMEs, Lloryn Hubbard, director, patient diversity, Cris Nieto, senior vice president of clinical operations, and Les Enterline, global head, functional service partnership solutions, share insights on key challenges CROs face and outsourcing and technology trends impacting clinical trials today.

Contract Pharma: What significant R&D trends are impacting CROs and services?

Lloryn Hubbard: One notable R&D trend impacting drug development is the increased focus on planning for the inclusion of historically underrepresented populations in clinical research. In the past year, ensuring diversity in clinical trials has transitioned from being seen as a mere “nice to have” to an absolute “need to have” for drug and device developers. This shift has been influenced by more directed efforts from U.S. legislators and the U.S. Food and Drug Administration to ensure medical products are safe and effective for all intended populations. 

As part of these efforts, sponsors are now required to submit and implement diversity action plans for their late-stage studies. However, the historical approach to diverse patient recruitment has been largely reactive, resulting in varying levels of readiness across the industry to respond to these new mandates. Sponsors are actively seeking CRO partners who help meet regulatory requirements and contribute to the broader goal of fostering inclusivity in clinical research. In light of these developments, CROs need to be prepared to offer nuanced subject matter expertise and tailored end-to-end solutions that effectively engage and retain clinically relevant patient populations throughout the trial lifecycle. 

Contract Pharma: Where do you see the most growth in outsourcing?

Les Enterline: We’re seeing significant growth in the use of global resources to keep projects on or ahead of schedule and at or below budget. This increase is most pronounced within functional service provider (FSP) solutions and hybrid FSP/full-service outsourcing (FSO) engagements, where we leverage functional expertise in regions such as Asia-Pacific, Latin America, and parts of Europe, Africa, and the Middle East to maintain operations around the clock and employ follow-the-sun models that seamlessly transition work and tasks across different geographic locations as the sun rises and sets. 

These types of arrangements provide readily available support and responsiveness regardless of time or location to ensure business continuity and minimize the risk of bottlenecks or delays in our client’s clinical development and post-marketing surveillance operations. Global resources also provide a larger pool of candidates to draw from and the ability for drug developers to expand their operations into regions and countries outside of their geographic footprint, which gives our clients greater expertise, efficiencies and flexibility to meet their timeline and budget commitments.

Contract Pharma: What are the biggest challenges CROs face in today’s market?

Cris Nieto: Some of the key challenges CROs are facing are:

• Increased protocol complexity: Protocols are becoming more complex in terms of procedures, involving multiple vendor interactions and an increase of the overall data volume to process. Investing in technology and digital solutions will be crucial to increase efficiency of study procedures, decrease site burden and help to bring research directly to the patient.
• Regulatory complexities: The regulatory landscape in clinical research is constantly evolving, with new guidelines and requirements being introduced. CROs must stay updated and ensure compliance with these regulations, which can be a complex and time-consuming process.
• Talent acquisition and retention: CROs require a highly skilled and agile workforce, capable of managing and reviewing large volumes of data with critical thinking. However, to achieve this, CROs need to invest in developing and retaining this top talent. 
• Data quality and security: With the increasing reliance on electronic data capture and digital platforms, ensuring data quality and security is of utmost importance. CROs must have robust systems and processes in place to protect patient data and ensure the integrity of clinical trial results.
• Technological advancements: The rapid advancement of technology in the healthcare and pharmaceutical industry presents both opportunities and challenges for CROs. While new technologies such as electronic data capture and remote monitoring can improve efficiency and data quality, CROs need to invest in these technologies and ensure their staff is trained to effectively utilize them. Most CROs lack a unified and streamlined system that can connect all the different steps of the clinical trial, providing a realistic end-to-end solution. Currently, in most cases, there are still many different solutions being used in silos without a true combined approach.

Addressing these challenges requires CROs to be adaptable, innovative, and proactive in their approach to meet the evolving needs of the industry and their clients.

Contract Pharma: What are the technology trends impacting clinical trials today?

Cris Nieto: In terms of study startup, current technology trends are aimed at improving efficiency, reducing costs and enabling faster initiation and enhanced collaboration among stakeholders. For example:

1.     Integrated Technology Platforms provide end-to-end management of clinical trial activities, including study startup processes such as site selection, document collection, contract negotiations and budgeting. The use of a single platform can streamline workflows, enhance communication within the team and with sites, and improve overall trial efficiency.

2.     Site Selection and Patient Recruitment Tools: Advanced data analytics and machine learning algorithms are being used to identify suitable trial sites and potential participants. These tools help optimize site selection and accelerate patient recruitment, thereby shortening study startup timelines.

3.     Regulatory Compliance Solutions: During study startup, technology solutions can streamline the preparation and submission of regulatory documents, ensuring adherence to local and international regulations.

In terms of monitoring, we are seeing increased usage of electronic medical records by sites. Various configurations of these records require clinical research associates (CRAs) to possess greater technological and validation knowledge to assess the adequacy of data. Real-time remote monitoring of multiple systems/platforms (eCOA, eDiaries, wearables, etc.) is becoming crucial for early detection of site trends and quality issues. This approach further enhances the delivery of high quality data.

 

Les Enterline serves as the global head of PPD™ Functional Service Partnership (FSP) solutions within the PPD clinical research business of Thermo Fisher Scientific. Prior to his current role, Les was instrumental in growing and developing government and public health services, vaccines, and the dedicated global project delivery group in peri- and post-approval. Les joined the business in 2014 and has more than 25 years of global experience in clinical research in the pharmaceutical industry.

 

 

Lloryn Hubbard is the director of patient diversity at the PPD clinical research business of Thermo Fisher Scientific, responsible for leading the company’s enterprise-wide vision and strategy to enhance health equity in clinical research. With over 14 years of clinical development experience at industry-leading pharmaceutical companies and CROs, Lloryn works to embed inclusive research solutions throughout the clinical development lifecycle to ensure clinical trials accurately reflect real-world patient populations.

 

 

Cris Nieto serves as senior vice president of clinical operations for the PPD clinical research business of Thermo Fisher Scientific. She is responsible globally for strategic leadership and operational oversight for in-country site startup, monitoring and support teams, as well as teams managing centralized monitoring. Since joining the business as an associate manager in 2001, Cris has held positions of increasing responsibility, including director and executive director of clinical management, and vice president of clinical operations and clinical team management.