Support for grant applications by CFAR principal investigators
In clinical trials, power calculation for sample size ensures that we have sufficient sample size for achieving a desired power for detecting a clinically meaningful treatment effect at a pre-specified type I error rate. Power calculation for sample size is critical especially when only limited budget and/or resources are available. The BCB Core will assist CFAR PIs in (i) power calculation for sample size estimation and/or justification, (ii) evaluation the merits and disadvantages of alternative designs, and (iii) preparation of statistical section for inclusion in the grant application for statistical/scientific validity of the grant application.
Support for clinical studies sponsored by CFAR principal investigators
The BCB Core will provide data management (including data quality and verification), statistical programming, and data analysis support to clinical studies sponsored by CFAR investigators to ensure unbiased (accurate) and fair (reliable) assessment of test treatments under investigation. In addition, the BCB Core will work closely with the investigators for interpreting the analysis results and preparing the manuscripts for publication consideration in leading medical journals.
Training on statistical issues commonly encountered in AIDS clinical research
In clinical trials, some critical statistical/scientific issues such as the selection of non-inferiority margin in non-inferiority (active control) trials, appropriate methods for missing data imputation, the establishment of predictive model using genomic markers, and advantages of clinical trial simulation are commonly encountered in AIDS clinical research. BCB will identify specific issues/topics that are of particular to CFAR investigators and then provide training such as seminars, tutorials, short courses, or workshops to CFAR investigators at regulatory basis.
Design and analysis of AIDS clinical research, especially on the potential use of adaptive clinical trial designs and statistical design for small scale exploratory studies
In recent years, the use of innovative adaptive methods in clinical trial has become very popular due to its flexibility and efficiency for identifying any signal, pattern, and trend of clinical benefits of test treatments under investigation. However, the quality, validity, and integrity of data collected from clinical studies utilizing adaptive clinical trial designs are of great concern to principal investigators and regulatory agencies. BCB Core will provide statistical consultation and support to clinical studies intend to use adaptive designs such as group sequential design, adaptive dose finding design, phase I/II seamless adaptive design, biomarker-adaptive design (target clinical trials), and other innovative adaptive clinical trial designs that are commonly used in AIDS clinical research to make sure the quality, validity and integrity of the intended clinical trials utilizing innovative adaptive clinical trial designs.
Perhaps a more pressing problem for typical CFAR investigators is how to design effective small-scale exploratory studies on a shoestring budget. Good statistical planning is critical for such studies, since small poorly designed studies may provide no useful information at all. We are interested in combining exploratory HIV/AIDS studies with clinical trial simulations in order to provide insight into the optimal design and strategies for using these small scale studies to launch randomized clinical trials.
Software and algorithms for analysis of immunological assays
Sometimes, vendor-provided software for the analysis of data from immunological assays perform poorly on specific data sets or are simply not available (for newly developed assays). We are happy to work with CFAR investigators to help find or develop the appropriate algorithms or software packages to analyze and summarize immunological assay data. For example, we have previously developed software and algorithms for the analysis of iTopia, Luminex and polychromatic flow cytometry assay data in collaboration with CFAR investigators.
Mathematical and statistical modeling of host-pathogen dynamics
We are happy to work with CFAR investigators who wish to develop and calibrate mathematical models of some aspect of host, pathogen or host-pathogen dynamics. Such models are typically expressed as systems of nonlinear difference equations or ordinary differential equations, and can provide insight into biological mechanisms typically not available with standard statistical approaches. For example, the effect of combination antiviral therapy was initially evaluated with the help of such models for viral dynamics.
Workshops on practical computing for research scientists
The BCB core runs annual workshops on practical computing for CFAR research scientists. The objective of these workshops is to increase the productivity of researchers by the use of software tools such as the Unix shell, text editors, databases, Python and R to facilitate data management, manipulation, analysis and reporting. These workshops are intended to convert novices into competent (not expert) users of powerful computational tools.