The QSU Clinical Trials Program is a leader in the design and analysis of clinical trials, including study design, independent statistical support of Data and Safety Monitoring Boards (DSMB), and independent validation of statistical analyses. This program oversees all clinical trials-related activities under the purview of the QSU.

Study Design. QSU members have expertise in designing both observational and experimental trials across all phases, including adaptive study designs.  We work with our collaborators to arrive at optimal study designs for the studies that we coordinate.

Statistical Analysis.  QSU members work with our collaborators to design scientifically sound and reproducible analysis plans. QSU members have strong expertise in how to handle missing data, the modeling of correlated and clustered data, and the analysis of right-censored data, among others.  QSU members work closely with our collaborators to implement analyses in a timely manner and to provide guidance on interpretation of findings. 

Data Management. QSU members have expertise in the creation of databases and development of software to implement tools for carrying out analyses.  We work with the research team to design secure IRB-compliant databases that are tailored for studies in which we are involved. 

Independent Statistical Group. QSU members are experienced in the role of Independent Statistical Group (ISG) providing statistical and logistical support for Data and Safety Monitoring Boards (DSMB), also called Data Monitoring Committees (DMC). Prior to the trial’s start, we guide the development of the DSMB charter and mock tables, listings, and figures for the DSMB’s review. During the trial, we prepare reports to ensure DSMB members are able to make informed decisions. In addition, we coordinate DSMB meetings and archive all documentation related to DSMB activities. The QSU is an experienced ISG who independently verify primary findings for clinical trials and to monitor randomization.

Education and Training. QSU members provide training to biostatisticians and clinicians in clinical trials and DSMB activities, including lectures, short courses, and shadowing experienced clinical trialists.

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

Featured Papers

1.     Rosas LG, Vasquez JJ, Naderi R, Jeffery N, Hedlin H, Qin F, LaFromboise T, Megginson N, Pasqua C, Flores O, McClinton-Brown R. Development and evaluation of an enhanced diabetes prevention program with psychosocial support for urban American Indians and Alaska natives: A randomized controlled trial. Contemporary Clinical Trials. 2016 Sep 30;50:28-36.

2.     Robinson TN, Matheson D, Desai M, Wilson DM, Weintraub DL, Haskell WL, McClain A, McClure S, Banda JA, Sanders LM, Haydel KF. Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS—a randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention. Contemporary Clinical Trials. 2013 Nov 30;36(2):421-35.

3.     Desai M, Pieper KS, Mahaffey K. Challenges and Solutions to Pre-and Post-Randomization Subgroup Analyses. Current Cardiology Reports. 2014 Oct 1;16(10):1-8.