Expertise in Adaptive Trial Design and Logistics
Your Guide to Successful Oncology Drug Development
Combining Adaptive Trial Design with Logistical Solutions
Phase Clinical Services enables you to accelerate drug development by providing two key success factors: expertise in adaptive trial design and leadership in providing logistical solutions.
You can accelerate the progress of oncology drug development, and reduce costs and research time through our in-depth knowledge of adaptive clinical trial design and operational management.
Realize the Benefits of Adaptive Trial Designs
Adaptive design makes the process of drug development more informative and efficient by pre-planning incremental decisions, using data and clinical feedback as it accrues. We work with you throughout the planning and execution of your study to identify beneficial adjustments to a trial procedure or data analysis while preserving the integrity and validity of the study.
We carefully assess the value of each type of adaptation — prospective, concurrent, and retrospective — to optimize the benefits realized from your study.
Improve the Success of Strategies Using Adaptive Trial Design Methods
You can achieve greater clinical development success with our accumulated experience in adaptive design methods, including:
- Adaptive randomization
- Group sequential design
- Sample size re-estimation
- Bayesian (drop-the-loser) design
- Adaptive dose finding
- Biomarker-adaptive design
- Adaptive treatment-switching
- Hypothesis-adaptive design
To ensure successful outcomes, we bridge the needs and expectations of sponsors with the reality of doctors and staff at the hospital sites.
Our trial managers regularly interact with hospital staff to gather research data and important practical feedback for further analysis – especially about parts of the process they think could be adjusted within the confines of the protocol – to make the trial more successful.
We also understand the growing value of genomic data to improve the efficacy of cancer treatment. For instance, predictive biomarkers are becoming increasingly important to enable biomarker-adaptive design. That is why we are developing new information resources to make more data about the patient population accessible. We can now assess 112 oncology biomarkers locally in network hospitals.
Reduce Risk Through Operational Management
We work to avoid the incidence of failure due to logistical issues. Reducing or eliminating the loss of opportunity and resources is a priority.
In building our research partner network, we look realistically at the capacity of sites and ways to work with staff to implement protocols correctly. We do this by managing information on the real patient population and the obligations of doctors that may be relevant to their participation.
By integrating our efforts, the needs of oncology drug developers, and feedback from clinical staff at study sites, we can develop solutions that minimize risk and provide the greatest clinical benefit.
Another crucial aspect of successful oncology clinical trials is patient enrollment.
In traditional approaches to clinical trial design, drug developers may resort to using theoretical patient recruitment numbers. Realistic patient enrollment information is vital if clinical data lags significantly behind other study arms.
Phase Clinical Services accumulates patient data and brings this to you – upfront for open, transparent discussion – to ensure the proposed trial can have a successful outcome.
As your CRO partner, we take an active role to limit reliance on theoretical data in trial design by providing real-world data on accessible patient populations.
Why Choose Phase Clinical Services
Oncology clinical development is becoming more costly and complex, which can make innovation of safe drug products take too long, especially for life-threatening diseases.
You can save considerable drug development resources and bring new products to market faster with our expertise in adaptive trial design and logistics:
- We are experts in addressing the complexities of oncology drug development with adaptive clinical trial designs.
- We proactively manage logistics that slow progress or cause failure and bring solutions to operational issues.
- We are a full-service oncology CRO, with a complete range of lab and research services available, including consultation to address your specific goals.