Office of Research and Development at The Queen's Medical Center

Introduction

The John A. Burns School of Medicine (JABSOM), University of Hawaii, and The Office of Research and Development (ORD), The Queen's Medical Center (QMC), see the need for coordinated and streamlined biostatistical/bioinformatical support for biomedical researchers (includes clinical, translational, basic). ORD has established a limited budget for QMC staff and affiliates to request biostatistical support through the JABSOM Office of Biostatistics & Quantitative Health Sciences (BQHS; http://biostat.jabsom.hawaii.edu). To manage the available funds, QMC staff in need of biostatistical support can access ORD funds under the following criteria: ** Note that QMC employees or clinical staff have to be the lead on a project for eligibility, and be present at the initial 1 hour consultation meeting.

Study Design

It is imperative that a research study be designed properly so that the conclusions are sound and valid. Basic study design (e.g. case-control, randomized), study objectives, and the appropriate subject population must be considered at an early stage of protocol development. The statistician depends on the researcher to provide information such as the minimum benefit that would be clinically relevant.

Sample Size and Power Calculations

Sample size and power calculations to ensure that the study will have adequate power to detect both the efficacy and safety outcomes of interest. The researcher needs to provide the minimum benefit that would be clinically relevant for the respective study population and research objective.

Statistical Analysis Plan

For most investigator initiated studies, a statistical analysis plan (SAP) is a brief summarization of the statistical approaches to be used when analyzing the data. For complex studies, an additional, more detailed statistical plan can be developed. Analyses must be planned prior to the start of the a study as changes to the SAP may affect the integrity, and therefore the validity of the data.

Note that in human research any changes to the SAP may also entail accountability to funding agencies, in particular the FDA. Any changes to the SAP have to be IRB re-reviewed to ensure that the rights, safety and welfare of the participants continue to be protected.

Randomizations and Sampling Techniques

Depending on the study design, we can provide you with the following:

Data Listings, Tables, and Figures

Data listings, statistical tables, and figures can be developed along with analysis results. They support the written analysis results and clinical findings of the study. Data listings are usually needed for formal submissions to regulatory agencies such as the FDA, and show subject data in an organized way such as patient demographics, vital signs, medical history, adverse events, and efficacy data. Statistical tables show summary data comparisons and include descriptive statistics such as n, mean, median, std and probabilities (p-values).

Publication and Presentation Preparation

Statistical writing requires specific terminology to describe the study outcome(s) accurately, and is complementary to the clinical aspects of the study. To request biostatistical support through the ORD/BQHS collaboration, submit ORD Form 7 (download here) to:

Lori Tsue
Fiscal Specialist
1301 Punchbowl Street, UH Tower 619
Honolulu, Hawaii 96813
Phone: 808.691.4121
Fax: 808.691.4055
Email: ltsue@queens.org