Step 5

The analysis of clinical trials

Clinical trials produce vast amounts of raw data requiring careful handling and analysis.

The results of the clinical trials are then presented at medical meetings and published in medical journals. Clinical trials follow a clear plan or ‘design’. Each sub study serves to answer a single important question.

To analyse trial data, researchers rely on tried and tested statistical methods, which have to be specified in a filing with the regulatory authorities before the trial even begins. This makes it possible to monitor and check what’s happening to the data at any time.

At participating trial centres, the bulk of the data is entered directly online and electronically processed for submission to the authorities.

Phase III clinical trials are conducted under the direction of an independent specialist in the disease area of interest. This ‘principal investigator’ is also the one who will present the results at a medical meeting or in a medical journal — even if the trial medication fails to produce the desired treatment response.

All of Roche’s trial protocols are posted along with the results of trials once they are completed on two websites that are available to the public: www.clinicaltrials.gov and www.rochetrials.com. We are also committed to publishing all of our global studies in medical journals.