Multi-cancer detection assays offer new opportunities to screen for many different cancers that currently have
limited options for early detection. The Cancer Screening Research Network (CSRN) will conduct definitive
clinical trials and studies to evaluate these assays. Design and implementation of screening trials involve many
challenges. Cancer incidence and death are rare events in an average risk population.Trial designs must
balance screening frequency, trial duration, and sample size to achieve trial objectives in a cost-efficient
manner. Implementation must anticipate issues such as non-adherence, non-compliance, and contamination.
Analysis must accommodate the design while adapting to the circumstances of implementation. The Statistics
and Data Management Center (SDMC) of the CSRN will offer a rigorous system for CSRN trial design,
management and analysis so that the information generated by CSRN trials forms a sound basis for national
cancer screening policy.
Our team brings together statistical leaders and clinical trial management experts with experience in major
clinical trials networks, including the Women’s Health Initiative Clinical Coordinating Center, the SWOG
Statistics and Data Management Center and the Early Detection Research Network Data Management and
Coordinating Center. We have expertly designed, implemented, analyzed and reported cancer screening,
prevention, and treatment trials. This work has required developing procedures and processes for expert
execution of trials and production of reliable results. It has necessitated creating close collaborations with
clinicians, scientists, patient advocates, and subject matter experts. And, particularly in the case of screening
trials, it has inspired development of novel statistical methods that have become established in the field.
Our goal is to promote excellence in all aspects of statistical and data management for the CSRN. To address
the critical questions regarding potential benefits and risks of new cancer screening methodologies, the CSRN
clinical trials must be designed and implemented with great integrity and efficiency to produce the most
knowledge possible within realistic constraints of time and resources. To attain these goals, the SDMC for the
CSRN has four specific aims: (1) Integrate the SDMC with the other CSRN components. (2) Provide rigorous
and high-quality designs and analysis for CSRN studies. (3) Build a state-of-the-art data system to ensure data
quality and integrity for CSRN trials. (4) Develop statistical and data management approaches to a large CSRN
screening clinical trial that would build upon the Vanguard study.
MCD testing represents a potential paradigm shift for cancer early detection. Successful execution of these
aims will ensure that the CSRN produces valid and reliable quantitative results concerning the efficacy and
benefit-harm tradeoffs of candidate products to support evidence-based policies concerning their use.