Enhancing Patient Recruitment in Clinical Trials: Strategies for Sponsors to improve CROs and Research Site Partnerships

09 Nov 2023

Optimizing patient recruitment for clinical trials

Widespread adoption of Decentralized Clinical Trials has made patient recruitment and engagement, much more competitive and challenging for pharmaceutical organizations. As Contract Research Organizations (CRO) and Clinical Research Sites are key stakeholders in recruiting and executing clinical trials, engaging with the right partners, and enabling them with digital excellence can significantly reduce these challenges, accelerate study timelines, and boost the quality of clinical study outcomes for sponsors.

To further explore these challenges and understand the state of digital maturity in patient recruitment, we hosted a webinar “Unlocking the potential of CROs and Research Sites’ partnerships to drive patient centricity”. In this discussion, our industry leaders Deepak Gandotra, Senior Director, Digital patient Recruitment and Engagement, Indegene and Francesca Properzi, Research Director, DT Consulting, an Indegene company, shared a few impactful strategies sponsors can adopt to enhance the execution of clinical studies. These strategies ensure interests of all stakeholders are aligned and existing processes and operations with these stakeholders are not disrupted.

Navigating diverse business priorities to successfully deploy digital engagement initiatives

The clinical trials ecosystem is complex involving clinical research sites, contract research organizations, and clinical trial participants. While the pandemic spurred digital transformation across the ecosystem, there is a huge variation in the scale of adoption and the extent of digital maturity by CROs and research sites mainly due to factors such as budget, strategic priorities, and ease of implementation. Consequently, at an ecosystem level, these efforts lead to poor trial design, delays in execution and most importantly low patient enrolment for new clinical studies as well as weak patient engagement for ongoing clinical trials.

The stakeholders’ business priorities in this ecosystem is different, their access to technology varies, and so does the culture of innovation. Hence, although they all strive towards a common goal of accelerating clinical studies, the siloed adoption of digital initiatives leads to delays rather than process efficiencies. When interacting with CROs to deploy digital tools for patient recruitment for ongoing trials, sponsors need to understand the CRO's recruitment activities in detail, ensure flexibility for collaboration with complementary recruitment channels, and have robust KPI tracking from day one.

As a sponsor of clinical trials, pharmaceutical companies can help CROs and research sites streamline their operations and prioritize their respective digital investments to meet the ultimate objective of achieving patient-centric clinical trials. Also, sponsors can consider whether to run digital engagement initiatives trial by trial or centrally depending on factors such as trial portfolio, budget constraints, and the ability to measure the impact of these initiatives. However, irrespective of the deployment model, it is important for them to measure the impact of these initiatives with discipline. Standardized frameworks, gap analysis, and roadmap creation are some of the necessary tools they need to adopt to measure the success of digital engagement initiatives.

Explore how Indegene used AI/ML Tools to help a biopharma accelerate patient recruitment and engagement.

Improve the CXQ (Customer Experience Quotient) score from research sites; support them with infrastructure, data, and seamless communication

Our research findings from the fourth DT Clinical tracker shows that almost 80% of the research sites are using digital tools. However, while the adoption of these tools for internal operations is on the rise, the adoption of patient-facing tools has stagnated. Understanding patient requirements, their ability to use digital tools, and costs associated with implementing them are some of the hurdles sites need to overcome to improve the usage of digital tools for patient recruitment. The research findings also revealed that 70% of patients still become aware of clinical trials through traditional methods, such as interactions with HCPs. This clearly indicates that although a wide range of tools is designed for clinical sites to recruit patients, challenges remain in effectively implementing them. To overcome this, and unlock the full potential of using digital channels, change management, along with effective workflow design is crucial, especially for rare diseases and oncology clinical trials.

Meanwhile, our other research survey which was on research site interactions with pharmaceutical companies revealed that the CXQ score given by research sites to sponsors is just fair indicating the wide gap that pharma companies need to address to improve this score, as sites with better scores have a stronger inclination to adopt advanced technologies to improve patient recruitment. The research further revealed that key factors that sites value in their relationship with sponsors are technical support, flexibility, and seamless communication, all of which have a direct impact on the quality of clinical studies they conduct. Transparent communication across stakeholders, including investigators and site staff, is vital; they should be treated as equal partners in the ecosystem, not just as execution arms.

Sponsors should address site-level infrastructure needs, data sharing, and privacy concerns to facilitate the use of advanced technologies such as real-world data and clinical trial analytics by research sites. For instance, adoption of Electronic Patient Records (EPRs) and electronic informed consent (e-consent) is largely influenced by sponsor support hence, additional support from sponsors will ensure they can be used more effectively. The potential of real-world evidence in patient recruitment is largely untapped by research sites and CROs. By using RWE, they can create effective omnichannel patient outreach programs tailored to the specific therapy area and geography. This becomes even more critical for rare diseases, where the reliance on patient advocacy groups to identify target population is very high and given the close-knit nature of such groups, access to valuable insights about these patients can strongly enhance study design for orphan drug trials.

Conclusion: Seamless communication and real-time KPI tracking are vital to drive sustainable digital initiatives with CROs and research sites

It is important for sponsors to maintain a flexible approach in adopting digital initiatives for patient recruitment for ongoing trials and upcoming clinical studies. For this, they should invest in site-level infrastructure, ensure data privacy, and drive effective and transparent communication with CROs and research sites. This will help them understand CROs’ and research sites’ capabilities, identify areas where they require assistance, and deploy digital tools that align with their operations. Along with this, they should use site-level CRM systems for insights and implement real-time KPI tracking. All these strategies will enhance the utilization of advanced technologies in clinical settings for improved patient care and research outcomes.

Author

Francesca Properzi