Study Design & Protocol Development
ACORN CRO can design studies that will meet a sponsor’s research objectives, and will compare the feasibility of alternative designs to maximize the return on the sponsor’s research investment. ACORN CRO can provide complete protocol development services. With basic research concept or background documents provided, ACORN CRO will develop a high quality protocol draft, revise following review and input from sponsor and key opinion leaders, and finalize a protocol suitable for submission to institutional review boards.
Protocol and CRF Review
ACORN CRO provides biostatistical review of protocols, case report forms (CRF), and other study documents. Review of protocols includes consideration of the appropriateness of the biostatistical content, including consistency of objectives with study measures and planned analyses. It also includes evaluation of the completeness of biostatistical content, and the quality of scientific presentation.
Review of CRFs entails matching of CRF content to protocol and/or statistical analysis plans. It also includes evaluation of the nesting structure of the data as implied by the CRF.
ACORN CRO can produce random allocation sequences for multiple group designs, with specified proportions assigned to each group, and with the number of stratification variables allowed by the sample size. The allocation sequence can be generated in blocks, with varying block length to reduce the risk that assignment will be determined and known by research staff.
Analysis Plan Development
ACORN CRO can produce or assist in the production of statistical analysis plans (SAP) for studies of varying complexity. Typical SAPs are free standing documents with abbreviated study background, a complete description of raw and derived variables, and specification of all descriptive and inferential procedures to be conducted. The SAP also specifies scheduled interim and final analyses by accrual or calendar schedule, the assessment points (for repeated measures) and the cohorts to be included in each analysis. For intervention studies, the SAP generally includes table shells, definition of figures to be generated, and listings to be produced (TFLs). For observational and retrospective research, TFLs generally include labeling and description of tables without production of table shells.
Analysis and Interpretation
ACORN CRO has expertise in the application of a wide range of statistical methodologies, including the following:
- Descriptive analysis of continuous, count, categorical, and censored outcomes
- Comparison of group means (univariate, multivariate, and repeated measures analysis of variance)
- Multiple linear regression
- Multiple binary and multinomial logistic regression
- Ordinal regression
- Linear mixed models for assessment of longitudinal data
- Nonparametric, parametric, and semi-parametric survival analysis methods
- Covariance structure modeling, including path analysis and latent variable modeling