Biotechs Increasingly Turn to CROs for Early-Phase Clinical Trial Support

In the ever-evolving landscape of pharmaceutical development, early-phase clinical trials have emerged as a critical juncture for biotech companies. A recent survey conducted by ICON sheds light on the challenges faced by these companies and the growing trend of partnering with contract research organizations (CROs) to navigate the complexities of phase 1 and early phase 2a studies.

Challenges in Early-Phase Clinical Development

Early-phase clinical trials represent a significant hurdle for biotech companies, with nearly half of all drugs failing to progress beyond phase 1. The financial stakes are high, as the average phase 1 trial costs millions of dollars and consumes valuable time. According to the ICON survey of 149 biotech professionals, the top anticipated obstacles when preparing for phase 1 trials include:

1. Navigating compliance and regulatory requirements (38%)
2. Biomarker selection (35%)
3. Protocol uncertainty (31%)

These challenges are compounded by the fact that many small and mid-sized biotechs operate with lean staffing, leaving little capacity for additional responsibilities. For companies developing complex and emerging modalities, balancing the need for deep therapeutic expertise with specialized knowledge in trial strategy and execution can be particularly daunting.

The Rise of CRO Partnerships

In response to these challenges, an overwhelming 84% of survey respondents indicated they were considering partnering with a CRO for their phase 1 clinical trials. These partnerships offer a range of support services, including:

1. Consulting and advisory services for funding and regulatory compliance
2. Therapeutic expertise across various indications
3. Operational perspectives on clinical site management and enrollment

When selecting a CRO partner, biotechs prioritize operational services and experience. The most sought-after offerings include:

• Access to healthy volunteers and patient populations (40%)
• Dedicated early-phase data sciences and reporting (35%)
• Asset development consulting, including dose selection (34%)

Strategic Insights and Development Planning

Beyond operational support, CROs bring valuable strategic insights to the table. Their experience with similar modalities or indications can help de-risk and expedite clinical development. This is particularly evident in the formulation of clinical development plans, a critical component of a drug candidate's success.

The survey revealed that the majority of biotechs seek external expertise for creating these plans:

• 37% partner with CROs
• 25% engage at least one, but often two or three consultants
• Only 38% rely solely on internal resources

This trend underscores the complexity of early-phase clinical development and the value that experienced partners can bring to the process. As the pharmaceutical industry continues to evolve, strategic partnerships between biotechs and CROs are likely to play an increasingly important role in bringing innovative therapies to market.