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THE PHARMA REVIEW (JAN – FEB 2019)

The Benefits of Statistical Consultancy for Clinical Trials

Quanticate

Introduction:

In the pharmaceutical industry, Statistical Consultancy services are often employed to provide statistical input to drug or device development programmes. This service offers independent statistical advice from outside the sponsor company, and this advice may cover issues from study design and strategies, to the analysis of study data and informed interpretation of results.
Statistics is regarded as one of the core disciplines of pharmaceutical research, which relies on the collection of objective data to demonstrate clinical effect. Data are the realm of the statistician: supervising data collection to provide meaningful measurable quantities; coding and manipulating data for a suitable analysis, having selected from a wide array of possible analysis options; and interpreting data with an appreciation of the play of random chance. Statisticians are often seen to bring an objective approach, consistent with their training (for example, they might rigidly insist on predefined ‘hypotheses’) which, coupled with the clinician/scientist’s knowledge and optimism, provides a framework for solid scientific advance.
Statistical Consultancy, therefore, brings the statistical perspective into the sponsor company - often from a practitioner with a good number of years’ service, who will have seen data of all shapes and sizes, the play of chance fall in all directions, and studies of different designs that either succeed or otherwise - to help achieve the objective of the trial at the point of conception.
So where do you look for such expert advice? Whilst in some situations Statistical Consultants may be individual contractors, more often they are embedded within a company such as a Clinical Research Organisation (CRO), where there is a high throughput of on-going studies at different phases, and consultants are part of a wider team of statisticians who can cross-fertilise their knowledge of current issues and developments in the field.

 

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