Clinical Trials Division

Clinical Trials Division

 

The Clinical Trials (CT) Division in the Center for Biostatistics is a diverse assembly of faculty and staff with a wealth of biostatistical experience in collaborative clinical research. Members offer comprehensive biostatistical support across a spectrum of research projects, including clinical trials, observational studies, cohort studies, and retrospective studies. The CT Division ensures rigorous, reproducible research through export collaboration through all stages of the research process, from conception to dissemination including clinical trial and study design, hypotheses generation and testing, analytical strategies development, data management, and research outcomes. Dr. Lai Wei leads the CT Division, overseeing all activities and operations.

 

Expertise

The CT Division provides expertise in the following main areas:

· Clinical Trial Designs

  • Sample size calculation
  • Power simulation
  • Multiple comparisons
  • Sample size re-estimation
  • Safety and efficacy monitoring

· Statistical Methods

  • Bayesian optimal interval designs
  • Group sequential designs
  • Adaptive designs
  • Mixed model for repeated measures
  • Survival and Competing Risk modeling
  • WinRatio for composite outcomes

· Clinical Trials Monitoring and Data Management

  • Randomization
  • Interim monitoring
  • Database support

CT Members

The CT Division is comprised of a group of faculty and staff biostatisticians who provide support and develop collaborative relationships with various departments in College of Medicine and other Colleges. For a full listing of members please see “Our People” on the CFB page. For more information about CT, email biostatistics@osumc.edu.

 

Select Successful Collaborations

 

· The NCI-funded UM1 grant (The Ohio State University as a lead academic organization (LAO) for the experimental therapeutics clinical trials network): We are helping to design phase I and II clinical trials to identify new agents with promising laboratory studies and develop them into new drugs for the treatment of patients with advanced cancer who have exhausted their treatment options.

· The NCI funded R01 (Targeting immunosuppressive adenosine in patients with metastatic non-small cell lung cancer): Conduct a phase 1b clinical trial of combination therapy with A2B adenosine receptor antagonist PBF-1129 and anti-PD-1 antibody nivolumab in patients with metastatic non-small cell lung

cancer (NSCLC); Also Evaluate the efficacy of combination treatment with PBF-1129 and nivolumab to reverse immunosuppressive phenotype of immune cells and TME in patients with advanced NSCLC.

· The NIH funded R01 (ABVENTURE-P: Pilot trial of abdominal core rehabilitation to improve outcomes after ventral hernia repair): Test with a feasibility randomized controlled trial of standardized post-operative physical therapy to improve function and patient-reported outcomes after ventral hernia repair.

· The NIH funded R01 (Randomized trial on mobile technology to reduce young drivers’ cellphone use). Conduct a randomized controlled trial to determine the effects of a cellphone app and a driving mode intervention in reducing cellphone use and high-risk driving events in drivers aged 18-24 years.

· The NIH funded R01 (Evaluating a multi-modal maternal infant perinatal outpatient delivery system: A randomized controlled trial (MOMI PODS RCT)). To address alarming trends in pregnancy-related mortality, we designed a program that delivers care to mothers and infants together and provides multiple types of support during the year after pregnancy – the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS).

· The NIH funded R01 (Short-term and long-term impact of COVID-19 on multiple sensory systems): Extensively investigate and capture short- and long-term COVID-associated multisensory dysfunctions, which will enable more comprehensive screening as well as better future support for patient recovery and care.

· The NIH funded R01 (Novel mechanisms and therapeutic approaches for nasal obstruction and olfactory losses): Develop novel clinical tools to better evaluate and relieve patients’ nasal obstructive symptoms and to enable patients and clinicians to make more informed, personalized decisions regarding treatment strategy.