Clinical trials are complex projects, whether it is a late phase study involving hundreds of individuals and spanning multiple years and centres, or a smaller early phase safety study. To ensure a successful trial, Sponsors need to carefully and precisely define all aspects of their trial, and this is where Datapharm’s expertise is vital. 

Before the trial begins, a significant amount of statistical work is required, such as selecting a scientifically defensible study design. We write the statistics section to be included in your study protocol in close collaboration with toxicologists, pharmacologists, and clinical experts.

Datapharm has experience with many study designs. First-in-humans (FIH) with single ascending dose (SAD) establish the maximum tolerated single dose of a drug. A multiple ascending dose (MAD) design can establish a steady state safety dose. We have also developed studies with parallel, Bayesian adaptive, crossover, and factorial designs. 

Also included in the protocol is the sample size for your study, which needs to be carefully determined and justified. Datapharm’s expertise is invaluable in providing sample size scenarios based on different effect sizes, power, and variability in the outcome so that the sponsor can select a scenario that suits their capabilities and budget.

Another document written early in the clinical trial timeline is the statistical analysis plan (SAP) containing more details about the analyses presented in the protocol. Datapharm writes this to ensure smooth clinical trial experience and compliance with ICH guidelines, and minimise bias. 

Most studies require a randomisation list to be prepared to allow packaging of the investigational product. Randomisation can be as simple or complex as the study requires, but our experienced statisticians can account for sentinel groups, stratification by various factors such as gender, site and country.

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5 Takeaways: Clinical trial preparation

  1. Early involvement with an experienced CRO, such as Datapharm, will make for a smoother and optimised trial experience 
  2. A well written protocol with a clear statistics section justifying the study design is essential to present to an Ethics Committees for approval and to design an appropriate database for data collection.
  3. Sample size calculation is critical and requires knowledge of the analyses to be performed, the intended significance and power levels, and estimated factors from previous studies, most commonly the expected effect size and variability in the primary outcome.
  4. A SAP contains details about analysis populations, primary and secondary endpoints, interim analyses, statistical tests, tables, figures, and is best signed off prior to finalising the data set to be analysed.
  5. All randomisation lists are kept securely so that the sponsor and our team cannot become unblinded during the study. If a code break is needed, investigators are provided with a codebreak password within an electronic data capture system.


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