The Clinical research industry is constantly evolving, and as a result, the need for a world-class clinical organization to optimize operational excellence has become more paramount than ever. Vial is a leading San Francisco-based contract research organization (CRO) dedicated to improving clinical trial management solutions and patient outcomes globally. Vial hosts a top biotech panel series called First in Human (FIH): The Panel Series. (Watch the first session here)

In Episode 2 of Vial CRO’s ‘FIH: The Panel Series’, four influential leaders in the clinical research industry discussed the importance of effective collaboration, avoiding bottlenecks caused by communication disconnect, streamlining protocol development, as well as considering the unique challenges of ophthalmology trials. The insights shared by the panelists are invaluable in understanding the complexities of ophthalmology clinical research and how to stay ahead of the curve in this rapidly evolving field.

In this article, we take a look at the five key takeaways from Vial CRO’s ‘First in Human (FIH): The Panel Series October Session’ that can help clinical professionals gain in-depth insight into the landscape of navigating clinical operations (ClinOps) for ophthalmology clinical trials.

Episode 2 of ‘First In Human: The Panel Series’: Meet the Host and Panelists

This episode was hosted by Bruce Gagnon, Senior Vice President of Global Clinical Operations at Opthea, as three influential biotech and pharma ClinOps executives shared their unique insights and experiences in the field of ophthalmology and clinical research.

• Jen Watts, VP of Clinical Operations – Early Development at Oculis
• Dr. Raj Agrawal, VP of Clinical Development and Ophthalmology Lead at Rezolute, Inc.
• Amy Del Medico, VP of Ophthalmology at Vial CRO

Read more on the panelists here. Continue reading to discover the top five insights from Episode 2 of Vial’s ‘FIH: The Panel Series’!

‘First In Human: The Panel Series’: Navigating the Ophthalmology Clinical Operations Landscape

FIH Insight 1 | The Crucial Need for Communication between Clinical Development and Clinical Operations

One of the main topics discussed during the panel was the importance of effective collaboration between the Clinical Development and ClinOps departments within biotech and pharma companies. It was emphasized that bringing these teams together early in the process can lead to more efficient trial design and execution because by consulting with ClinOps colleagues, clinical development teams can gain valuable insights into operational feasibility, patient recruitment, and realistic timelines.

Strengthening this collaboration ensures that the study design is practical and aligned with real-world scenarios, ultimately speeding up the access to new drugs. The collaboration between clinical development and ClinOps is also crucial in ensuring that the objectives of the study are met, while also considering the practical aspects of conducting the trial. By working together from the beginning, these teams can address potential challenges, identify solutions, and optimize the trial design to enhance patient recruitment and engagement.

FIH Insight 2 | Proactively Addressing Bottlenecks from a Collaboration Disconnect

The panel also addressed the common pitfalls and bottlenecks that can arise when there is a disconnect between the clinical development and ClinOps departments. Dr. Agrawal discussed the need for these two sides to work together closely to prevent such issues. Clinical development teams should consider the practicality and cost-effectiveness of the study design, while ClinOps teams should be aware of the clinical development perspectives in terms of site selection and study execution.

When there is a lack of communication and collaboration between these departments, it can lead to delays, inefficiencies, and increased costs. For example, if clinical development designs a study without considering the operational feasibility, it may result in challenges during site selection or patient recruitment. On the other hand, if the ClinOps team is not aware of the specific objectives and requirements of the study, they may face difficulties in executing the trial effectively. By fostering open communication and collaboration, these pitfalls and bottlenecks can be minimized, leading to smoother trial operations and better outcomes.

FIH Insight 3 | Streamlining Protocol Development to Cut Costs and Patient Burden

During the live panel, the experts also highlighted the importance of streamlining protocol development in early-phase trials by biotech and pharma sponsors. Jen Watts suggested that early development teams should focus on essential exploratory measures and secondary endpoints that have scientific importance. By conducting protocol leaning exercises and utility reviews, both clinical development and ClinOps teams can evaluate the feasibility and relevance of the included assessments. Protocol development plays a crucial role in determining the success of a clinical trial. Streamlining the protocol ensures that unnecessary assessments and procedures can be eliminated, reducing the burden on patients and improving overall trial efficiency. This approach allows for a more patient-friendly and cost-effective study design, ultimately benefiting both the patients and the company.

FIH Insight 4 | Understanding the Unique Characteristics of Ophthalmology Trials

The panelists also discussed the unique challenges and opportunities in conducting clinical trials in ophthalmology. One of the key challenges mentioned was the need to recruit patients within a specific period, which may require expanding the trial to multiple countries or regions. When entering new countries, considerations such as the availability of potential sites, standard of care, competitive landscape, and startup timelines must be considered.

Understandably, ophthalmology trials have their own set of challenges due to the specific nature of the diseases being studied. The experts emphasized the importance of understanding the specific therapeutic landscape in ophthalmology, including the various diseases and treatment modalities, to effectively design and execute trials in this field. By considering the unique characteristics of ophthalmology trials, such as the need for specialized equipment and technological expertise, study sponsors can better plan and execute their trials, leading to improved patient recruitment and more meaningful results.

FIH Insight 5 | The Importance of Cross-Functional Collaboration

Throughout the panel discussion, the significance of cross-functional collaboration was emphasized. The experts stressed the importance of involving various stakeholders, including clinical development, ClinOps, and service providers, in the trial planning and execution process. Cross-functional collaboration brings together diverse perspectives and expertise to ensure that all aspects of the trial are considered. By involving multiple key stakeholders and opinion leaders, the trial design can be optimized, potential challenges can be addressed, and innovative solutions can be explored. This collaborative approach ensures that the trial is conducted efficiently, while also meeting the needs and expectations of all stakeholders involved.

In conclusion, the second episode of Vial’s ‘FIH: The Panel Series’ provided valuable insights into the collaboration between clinical development and clinical operations, the challenges and opportunities in ophthalmology trials, and the importance of streamlining protocol development. By embracing cross-functional collaboration and considering the practicality and feasibility of trial designs, the field of ophthalmology can continue to advance and bring new treatments to patients more efficiently.

Stay Tuned for More from Vial CRO’s ‘First in Human: The Panel Series’

Vial CRO’s ‘FIH: The Panel Series’ is a live online panel discussion bringing together influential leaders in the clinical research industry. For this 60-minute panel, we feature a handpicked selection of ClinOps executives and ophthalmology experts, where panelists engaged in insightful discussions tailored to their specific areas of expertise. Access the recording of Episode 2 here to watch on demand.