Having your drug candidate make it out of preclinical and early phase studies is a major milestone – as many oncology candidates don’t make it past Phase 1. But now what? How do you transition from early phase studies to commercialization?
To take this step in the drug development journey to commercialization, biotech companies often engage a contract research organization (CRO) with the required experience and capabilities for running successful clinical trials. A partner with global knowledge can help biotech companies define and implement the best strategies and pathways to move their therapy forward rapidly and cost-effectively, giving them a tremendous competitive advantage. Key considerations must also be made as they navigate the next phase.
Going global
For many biotech companies, early phase and Phase 1 studies are typically small scale, taking place in just a few sites within a single country or region. When transitioning to Phase 2 studies, companies now must shift to a broader, often global approach, which can bring many challenges, especially if this is a new area of operation.
What’s more, the budgetary impact of such a transition must be acknowledged – as a clinical trial's duration is most often the primary driver of clinical trial cost. Phase 2 studies are a more expensive undertaking than Phase 1 work. Many biotechs are focused on raising funds to advance their research, and therefore need to ensure their budget allows for that.
Flexibility
In recent years, the transition from early phase to Phase 2 studies has become more streamlined. Companies are now taking a more adaptive approach and implementing protocol amendments which allows them to easily move into Phase 2 studies. However, this approach requires an incredible amount of flexibility.
In the oncology space, flexibility, and quick but calculated decision-making becomes even more crucial. Patient populations have life-threatening conditions greatly affecting their quality of life – there’s a strong sense of urgency, which along with internal corporate milestones results in aggressive timelines to find impactful therapeutics. A successful Phase 2 trial can benefit from a CRO partner that can create a tailored service that matches exactly what the sponsor needs, when they need it, and with the shortest duration possible.
Data-driven capabilities
Patient recruitment can be one of the biggest challenges when moving into Phase 2 studies, as well as one of the risks to completing the study on time. In fact, nearly half of clinical trial sites miss patient enrollment targets for various reasons.
Today’s complex protocols and competing trials lead to exponentially greater challenges to recruiting and retaining qualified participants. IQVIA Biotech can connect the right resources and IQVIA capabilities together to build the patient recruitment and engagement solutions needed to keep complex clinical trials running on time and on budget.
With real world data, insights and advanced technology, IQVIA broadens the identification of patients within and beyond the site’s database, delivers strategies to support site-based recruitment, and engages directly with patients. These capabilities provide a direct impact on individual studies and inform overall delivery strategies.
Scientific strategy considerations
Most biotech companies may undersize their clinical trials due to funding constraints and having their expectations influenced by their own (or external consultant) expertise during study planning. This can increase the risk of the study failing to satisfactorily achieve its objectives and disrupting progress through the drug development journey. This is why scientific strategy considerations should be discussed prior to trial delivery. The most efficient trial delivery has its roots in proper planning and the development of accurate study assumptions.
Companies may want to reach out to experts in the field for input as early as possible in the clinical development planning process. It’s important to get feedback from a variety of stakeholders on study design, including enrollment projections, study duration and budget. This can help avoid incorrect study assumptions while simultaneously establishing expectations around cost, milestone setting and program goals. Having a CRO provide a detailed set of study assumptions based on a protocol synopsis with a detailed schedule of events, or schedule of assessments, ensures you are comparing the same specifications for a more accurate cost and capabilities comparison.
Summary
In the race to get urgently needed treatments to patients, time is of the essence. The move from early phase studies to Phase 2 is an exciting, yet demanding transition that requires the need to move quickly. To help with this transition, working with a CRO should be considered, particularly one with global knowledge and expertise to provide guidance through this next phase in drug development. Flexibility, clear communication, and a comprehensive strategy with data-driven capabilities will help ensure success.
IQVIA Biotech employs a flexible and adaptable approach to align with each customer’s needs. The process begins with the initial alignment meeting where we listen to our customer and have an open conversation in order to outline the approach and discuss the most efficient way to perform the study. This helps clarify the scope of the trial, allowing for the development of a sound strategy and to ensure the work is achieved in a timely, efficient manner. Our goal is to help our customers get their life-saving therapeutics to commercialization as efficiently and cost-effectively as possible so that patients can receive the treatments they need.
Contact us to discuss how we can help support your Phase 2 clinical trial.