Smooth Drug Development provides biomedical statistics services in clinical trials.
Statistical analysis is one of the main stages in clinical trials. The work of a statistician is vital during study design preparation, study Protocol writing, patients sample size calculation and during the analyses of data obtained during a clinical study.
It is well known that requirements of Regulatory Authorities to biostatistics are getting stricter. A wrong selection of hypothesis or incorrect sample size calculation can lead to a clinical study failure.
Sample size calculation affects not only the results of the clinical study but also its timelines and cost. The results of various hypotheses and calculation methods can result in enormous differences.
In cases when it is scientifically grounded, our specialists can prepare Protocols with an adaptive design, which can result in shorter timelines and a lower budget of the trial.
An adaptive clinical trial is a clinical trial that evaluates a treatment by observing participant outcomes on a prescribed schedule, and modifying parameters of the trial protocol in accord with those observations. Such modifications may include inclusion and exclusion criteria, randomization procedures, patient sample size, treatment regimen of different therapeutic groups, treatment procedures schedule, concomitant medication, study endpoint and methods of statistical analysis. Our company has good experience in clinical studies with adaptive designs including studies with interim analysis resulting in sample size recalculation and phase II-III combination studies.
Biostatistician’s work starts during Protocol synopsis development when different options of the study plan are calculated based on available literature data.
After the client approves the Protocol, a statistical analysis plan is prepared. Statistical analysis plan is a document describing all activities connected with statistical analysis. The document regulates the procedures of software usage, variables, outliers and defines results comparison and assessment criteria.
Before the database lock, biostatistician assesses if obtained data is in accordance with statistical analysis plan. After the database lock, biostatistician performs analysis and develops statistical report, which includes analytical and descriptive parts.
Depending on client’s requirements our specialists use software packages of SAS/STAT®, Statistica® and program package R, Pass 12 and others.
Our company provides the following services:
- Hypothesis and endpoints determination
- Development of various study designs
- Patient sample size calculation
- Sample size re-calculation using specific tests
- Randomization list preparation
- Development of statistical analysis plans
- Statistical analysis and results interpretation
- Interim and final statistical report development
Statistical report is provided to a medical writer, who prepares a clinical study report.