SERVICES

CLINICAL TRIAL DESIGN

Design of a clinical trial requires consideration of statistical issues on the ability of a trial to show a treatment is efficacious.

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These statistical issues can be quite complex.

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Design issues to consider are:

Choice of patient population

Choice of Comparator

Choice of estimands

Avoidance of bias in trial design i.e. blinding, randomization.

Missing data

Data monitoring/interim analyses.

Multiplicity

Protocol statistical section authorship

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OSTATISTICS can partner with you to help designing a clinical trial that provides the proof you need while addressing the various complex design issues. 

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POWER AND SAMPLE SIZE

Generally a clinical trial protocol requires a sample size justification that looks something like: 

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A sample size of N in each group will have P Power to detect a difference in means of D (dd being the difference between a GroupNew mean of Mnew and a GroupControl mean Mcont on the primary endpoint) assuming that the common SD of the primary endpoint is SDc using a two group t-test with a alpha=0.050 two-sided significance level. 

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OSTATISTICS will partner with you to develop a sample size and power justification that will be able to proof that the new treatment works considering the provided scientific assumptions.  

REGULATORY AND ETHICAL COMMITTEE INTERACTION ON TRIAL DESIGN

Regulatory agencies have developed a large number or global (ICH), national (FDA, NMPA, MHRA) or regional (EMA) documents to provide guidance to companies and investigators designing and planning clinical trials to confirm a future product claim. 

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Gonnie van Osta has a longstanding experience in applying drug development guidances and participating in sponsor interactions with regulatory authorities. 

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OSTATISTICS can assist you during your regulatory and ethical committee interactions on clinical trial design and analysis. 

SAP

Regulatory Authorities regularly request sponsors to submit both a protocol and a so-called SAP (Statistical Analysis Plan). 

OSTATISTICS can develop a detailed Statistical Analysis Plan adressing the relevant statistical design and analysis issues corresponding to a protocol.