Designing and analyzing clinical trials comes with specific challenges. Our group can help address these challenges and increase your chances of obtaining funding, or avoid delays in receiving approval from an institutional review board. Already in the grant writing phase, we can advise on the most suitable trial design, required sample size and preferred analysis method. In later stages, we write statistical analysis plans and perform or support statistical analyses. We have both experience with trials that use a standard randomized controlled trial design and trials that use innovative designs (see the applications tab for some examples). In addition to the services listed below, we also offer general statistical support through Julius support.
For inquiries about services below, contact Peter van de Ven.
We provide expert methodological and statistical input in grant applications for clinical trials, including advice on the most suitable trial design, the required sample size, and a summary of the planned statistical analyses.
We help select the most appropriate design for a clinical trial and provide you with the required sample size, considering both the research question, operational and feasibility aspects.
We write statistical analysis plans (SAPs) for trials. SAPs contain detailed information about all statistical analyses to be performed upon study completion. High-impact journals require sharing the SAP at time of manuscript submission. A SAP is also essential for trials with intent to file for marketing authorization applications.
Trials become more complex in terms of their design, but also in terms of their analysis. An example is the need for complex imputation strategies to align with the defined estimand and procedures to control type I error across multiple endpoints. We write scripts for (complex) statistical analyses and support with interpretation and reporting of results and methods.
We have expertise in serving as statisticians on (external) data safety monitoring boards and as independent statisticians providing the tables for the interim DSMB reports.