Email:
global@GCP-ClinPlus.com
In the life-critical exploration of anticancer drug development, the success or failure of clinical trials largely depends on the scientific rigor and
foresight of their statistical strategies. As a global CRO with 22 years of experience, having supported the successful approval of 210+ products,
GCP ClinPlus's Data Science Business Unit is consistently at the forefront of methodological innovation. We conducted an in-depth conversation
with the Head of the Data Science Business Unit, sharing how we translate statistical science into our clients' success.
Q: Facing the unique challenges in oncology clinical trials, such as endpoint selection and population definition, what insights has GCp ClinPlus accumulated?
A: The challenges in the oncology field are rooted in its scientific and ethical complexities. Drawing from our practical experience in over 550 oncology projects, we recognize that a single go ld-standard endpoint (like OS) is often insufficient to meet the needs of efficient R&D. The key lies in how to scientifically utilize surrogate endpoints such as PFS and ORR, and to deeply un derstand their relationship with ultimate clinical benefit. This is precisely where our professional value manifests – we not only perform analyses but are also committed to working with clients from the protocol design stage to define clear scientific questions. Simultaneously, we possess deep expertise in leveraging biomarkers to precisely define populations. Our Oncology Business Unit works closely with the Medical Science department to ensure precision and accuracy in every step from strategy to execution.
Q: With the increasing prevalence of Multiregional Clinical Trials (MRCTs) in oncology, what experience and strategies does GCp ClinPlus have in this area?
A: Globalization is an inevitable path in oncology drug development. We have accumulated experience in over 120 FDA/EMA submission projects and supported the approval of 4 products in Europe and the US, for instance, by participating in the entire global R&D process of Orelabrutinib. The core challenge in executing MRCTs lies in handling regional heterogeneity—this encompasses not just differences in efficacy, but also variations in medical practices, epidemiological backgrounds, and regulatory requirements.
Our strategy is systematic: First, during the trial design phase, we leverage the experience of our former FDA reviewers and global regulatory affairs team to align strategies with regional regulatory agencies in advance, ensuring the protocol's scientific validity and acceptability. Second, on the statistical front, we employ so phisticated techniques to assess the consistency of treatment effects across regions and, when necessary, design bridging studies to provide a solid foundation for extrapolating global evidence. Finally, operationally, our teams spanning Asia, Europe, and North America, coupled with our mature centralized server platform, ensure compliant, consistent, and efficient global data collection and management.
Q: How does GCp ClinPlus employ modern statistical methods to address these challenges and ensure both R&D efficiency and scientific rigor?
A: Our methodology is built on three pillars: Innovation, Rigor, and Foresight. On innovation, we widely apply adaptive designs like group sequential and basket designs to enable "learning while testing." This is supported by over 110 online tools developed by our AI Innovation Center and AI-assisted QC processes, which can improve timeliness by 40%-50% during the statistics and programming phase.
Regarding rigor, we mandate the use of the "Estimand Framework," systematically addressing complex scenarios like treatment switching at the design stage to ensure clear and robust efficacy evaluation. The core members of our Biostatistics team have an average of over 17 years of experience, and are proficient in multiple testing control strategies, including graphical approaches and fixed-sequence testing, ensuring the reliability of results is not compromised when exploring multiple hypotheses.
Q: Looking ahead, what are Gcp ClinPlus's strategic focuses in the statistics of oncology clinical trials?
A: We will continue to focus on the deep integration of data science and cutting-edge therapies. On one hand, our AI Innovation Center is dedicated to further integrating Artificial Intelligence into data cleaning, patient stratification, and trend prediction to enhance the intelligence level of R&D decision-making.
On the other hand, we are systematically extending our profound statistical experience from traditional oncology into frontier areas like Cell and Gene Therapy (CGT). Our CGT Business Unit already has experience in over 80 CGT projects and successfully supported the approval of China's first stem cell product. We deeply understand the unique complexities of CGT products (such as CAR-T, AAV vector therapies) in areas like cell kinetics and biodistribution, and have established specialized analysis and modeling capabilities to meet the new statistical challenges posed by next-generation therapies.