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Complex therapeutic development requires deep integration across clinical, regulatory, statistical, and operational functions. Whether optimizing dose, navigating regulatory pathways, or accelerating timelines, early and sustained collaboration is essential to designing and executing high-quality clinical programs. No single discipline can manage this complexity alone.
Success in this new era requires breaking down silos between teams from the earliest stages of development. As John Balser, Ph.D., Veristat’s Founder, President, and Chief Statistical Officer, noted during a recent Veristat Oncology Center of Excellence discussion:
"We don't simply stick with mathematics for doing a sample size calculation. You have to look at other clinical and regulatory implications. What it really implies is that we need a team approach."
👉 FDA's New Direction
An integrated approach helps sponsors:
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Design more informative studies: Multidisciplinary input leads to stronger study designs that better characterize dose-response relationships.
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Interpret data holistically: Safety, efficacy, PK/PD, and patient experience must be considered together.
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Present cohesive regulatory narratives: Input from all functions strengthens the justification for key decisions.
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Anticipate operational challenges: Early involvement of operations ensures scientific goals remain feasible.
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Adapt to evolving science: Tailored strategies are essential across small molecules, biologics, and advanced therapies.
👉 Starting Collaboration Early
Cross-functional collaboration should begin before the first protocol is drafted. Engaging all key functions early— especially ahead of regulatory interactions like pre-IND meetings— results in more aligned strategies and stronger development programs.
Successful early planning brings together:
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Clinical input on patient populations, endpoints, and practical dosing considerations
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Statistical perspective on study design, endpoint measurements, missing data handling, sources of bias, sample sizes, and analytic approaches
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Regulatory insight on regulatory expectations and precedents
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Operational assessment of feasibility, timelines, and resource requirements
👉 Building Effective Cross-Functional Processes
To achieve meaningful collaboration, it's not enough to simply assemble a multidisciplinary team—organizations must also establish structured processes that enable alignment and informed decision-making. When roles, communication pathways, and shared goals are clearly defined, cross-functional teams can operate more cohesively and efficiently. Key elements include:
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Joint strategy development: Cross-functional teams should collaboratively develop strategy for dose optimization, including a structure for ranking doses for comparison during trial planning.
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Regular integrated data reviews: As data emerges, all functions should participate in data review and interpretations.
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Shared responsibility for regulatory interactions: Preparation for FDA meetings should draw on expertise from all relevant functions.
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Transparent decision-making: Criteria for dose selection should be established with input from all disciplines and communicated clearly.
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Continuous knowledge sharing: Regular forums for discussing emerging data, regulatory precedents, and methodological advances help keep the entire team aligned.
👉 The Path Forward
As the clinical development landscape continues to evolve, sponsor organizations that build strong cross-functional collaboration models will gain a clear competitive edge. By integrating expertise across disciplines, these teams can design better studies, streamline development, and improve outcomes in regulatory interactions. This approach leads to higher success rates, reduces the risk of post-approval dose modifications, and enhances the ability to optimize dosing for special populations. Ultimately, it ensures teams are better prepared to address complex regulatory questions. At Veristat, we bring together clinical, statistical, regulatory, and operational expertise in a fully integrated way, empowering sponsors to meet regulatory expectations with confidence.
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