Clinical Trials

The QSU Clinical Trials Program stands at the forefront of designing and implementing clinical trials. As the largest group of biostatisticians within Stanford Medicine, we are leading efforts in AI evaluation, healthcare optimization, and clinical trials to ensure that data-driven decisions are advancing patient care and improving clinical outcomes. Through our Clinical Trials Program, we are advancing the science of clinical research, ensuring the rigorous design, execution, and analysis of clinical trials that form the backbone of medical discoveries.

Our expertise spans across comprehensive study design, leadership of Data Coordinating Centers and Biostatistics Cores, providing robust statistical support as the Independent Statistical Group to Data and Safety Monitoring Boards (DSMB), and conducting independent validation of statistical analyses. The QSU Clinical Trials Program meticulously oversees all clinical trials activities, ensuring rigorous standards and reliable outcomes.

Our Clinical Trials subprogram is led by a team of expert faculty and staff biostatisticians who collaborate with peer scientists and clinicians in designing, analyzing, and interpreting clinical trial data. Our work ensures that clinical trials are scientifically robust and that their findings are actionable, reproducible, and impactful for advancing patient care.

At the QSU, we collaborate closely with partners to design scientifically robust and replicable analysis plans.  Our team boasts profound expertise in handling challenges such as missing data, modeling of correlated and clustered data, and analyzing right-censored data, among other complexities. We prioritize timely implementation of analyses and offer comprehensive guidance on interpreting findings, ensuring rigorous scrutiny and clarity in research outcomes.

The QSU excels in developing databases and software tools essential for executing sophisticated analyses.  Collaboratively, we partner with research teams to design secure, IRB-compliant databases specifically customized for our studies. Our focus is on integrating robust data management solutions that streamline processes and uphold the highest standard of data security and regulatory compliance.

The QSU Clinical Trials Program works to translate research findings into clinical practice, ensuring that promising therapies move efficiently from the research phase to patient care. The insights generated from our clinical trials directly inform evidence-based clinical practice. We work closely with clinical departments to ensure that trial findings are translated into actionable healthcare interventions, ensuring that medical discoveries benefit patients as quickly and safely as possible.

The QSU Clinical Trials Program plays a key role in the national influence of clinical trials standards, as significant contributors to national conversations around clinical trials design, methodologies, regulations, and operational guidelines and standards. Our program is a recognized leader in developing innovative trial designs that improve the efficiency and accuracy of clinical research. Our research is setting new standards for the clinical trials industry and informing national guidelines and best practices.

The QSU is highly experienced is serving as an Independent Statistical Group (ISG), providing crucial statistical and logistical support for Data and Safety Monitoring Boards (DSMB), also called Data Monitoring Committees (DMC). Prior to trial commencement, we play a pivotal role in developing the DSMB charter and mock tables, listings, and figures for comprehensive review by the DSMB. Throughout the trial, our team meticulously compiles and presents reports to ensure DSMB members are equipped to make well-informed decisions. We also oversee the coordination of DSMB meetings and archive all documentation related to DSMB activities. With a focus on independence and accuracy, the QSU diligently verifies primary trial findings and monitors randomization processed, reinforcing our role as a trusted Independent Statistical Group in clinical research.

The QSU delivers comprehensive training to biostatisticians, data scientists and clinicians on clinical trials and Data and Safety Monitoring Boards activities through engaging and interaction lectures, tailored short courses and hands-on shadowing opportunities with seasoned clinical trial experts. Our commitment to nurturing expertise ensures proficiency and confidence among collaborators and partners in navigating the complexities of clinical research.

For further information, please contact Dr. Haley Hedlin, Associate Director of the QSU Clinical Trials Program at hedlin@stanford.edu.