The role of statistics in clinical trials
Statisticians and biostatisticians are more and more present in clinical trials, since the early stages, like for instance the design itself. On the contrary, until recent years statistics was referred to only after the conclusion of the trial, often with negative effects.
Today it is neither ethical not scientifically acceptable that patients undergo therapies, tests and treatments that are not necessary and whose use is not rational.
In the light of these reflections, the role of the biostatistician becomes essential to manage and interpret any data from clinical research. It is a very important figure in any clinical trial, from its design to its carrying out, from analysis to documentation, for the control and containment of distortions and misleading factors and for the calculation of casual errors. Mastering statistical methods is essential to understand the methods and results of randomised clinical trials.
Today anyone can make complex statistic calculations thanks to statistic softwares that are more and more powerful, but one must be aware of the scopes of the trial as well as the more suitable method to use to generate statistic data and understand their significance. Therefore, the task of the sponsor and of all the other parties involved in the trial is to start specific procedures to ensure that statistic principles are appropriately implemented.
A clinical statistician should then possess a combination of training and experience that are sufficient to apply statistic methods in a suitable way and take in the responsibility of the trial statistic result.
The principle of an appropriate statistic design regarding a clinical investigation are finalised at minimising unknown or suspected sources of bias (that could compromise the ability of drawing valid conclusions) maximising at the same time its precision.
A responsible planning of a clinical trial should take place in a synergic cooperation between the clinician and the biostatistician, as the first contributes to the investigation rationale, providing the suitable background on the type of trial, with a definition of the primary and/or secondary scopes, while the second should be able to turn raw data from the information collected and filed in the electronic records (CRF) into concrete answers on the trial progression.
It is in fact from the final confrontation between the clinician and the biostatistician in the submission of the trial results, that new inputs for investigation and new scopes to achieve can arise.
